Product Development PortfolioLast update: Oct. 17, 2018

Therapeutic Area
Partner
Managed By
Compound/
Generic name
Trade name
Indication
Phase
123f
Expected Filing

1. Oncology

1. Oncology
CHU
solid tumours
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. ERY974 is a bispecific antibody designed to elicit T cell activation and T cell-dependent cellular cytotoxicity by simultaneously binding to glypican-3, a protein expressed in certain cancers, and CD3 on the surface of T cells.

Managed By:
3. Chugai
Partner:
Chugai
1. Oncology
CHU
solid tumors
4. Phase 1

Description/Summary:

CKI27 is a small molecule MEK inhibitor with a novel structure based on a coumarin skeleton. It selectively inhibited Raf1 (C-Raf), B-Raf, mutant B-Raf (V600E), and MEK1 in in vitro studies and showed a strong and broad spectrum of antitumor activities both in vitro in various tumor cell lines and in vivo in mouse xenograft models.

Managed By:
3. Chugai
Partner:
Chugai
1. Oncology
RG6026
relapsed or refractory non-Hodgkin's lymphoma
4. Phase 1

Description/Summary:

RG6026 (anti-CD20 CD3 TCB) is a 2:1 format T cell-engaging bispecific antibody, designed to engage both CD20 on B cells and CD3 on T cells. By engaging both targets simultaneously, the antibody activates the T cells to attack and eliminate the B cells, allowing treatment of B cell cancers such as non-Hodgkin’s lymphoma.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6058 tiragolumab
solid tumours, combination regimen with Tecentriq
4. Phase 1

Description/Summary:

RG6058 (anti-TIGIT, MTIG7192A) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor.

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6109
Acute Myeloid Leukemia (AML)
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6114
hormone receptor-positive breast cancer
4. Phase 1

Description/Summary:

RG6114 (GDC-0077) is a small molecule PI3 kinase (PI3K) inhibitor. Dysregulation of PI3K signalling is implicated in a broad range of human cancers, and activating mutations in the PI3K alpha-isoform gene (PIK3CA) are common oncogenic drivers. The PI3K/Akt/mTOR pathway regulates cell growth and survival.

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6123
Solid tumours
4. Phase 1

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6146
oncology
4. Phase 1

Description/Summary:

RG6146 is a small-molecule inhibitor of BET (bromodomain and extraterminal family) proteins (BRD2/3/4/T), interfering with the protein-chromatin interaction. By preventing binding to acetylated histones, RG6146 inhibits pTEFb-dependent transcription from enhancer and super-enhancer regions, leading to down-regulation of genes regulating growth and survival of cancer cells (e.g., MYC).

Managed By:
2. Pharma Research and Early Development
Partner:
Tensha acquisition
1. Oncology
RG6148
HER2+ Breast Cancer
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6160
multiple myeloma
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6171
ER+/HER2- metastatic Breast Cancer
4. Phase 1

Description/Summary:

RG6171 (GDC-9545) is a selective estrogen receptor degrader (SERD) that is designed to bind to the estrogen receptor to limit its function. In addition, when SERDs bind to the estrogen receptor, they may be able to change the shape of the receptor in such a way that the cell eliminates it by degradation.

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6174
Inflammatory diseases
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6180
oncology
4. Phase 1

Description/Summary:

RG6180 is a messenger RNA (mRNA)-based, individually tailored, personalised cancer vaccine. Each vaccine will be made using unique neoantigen signatures from an individual patient’s tumour, which is expected to elicit an effective immune response against that patient’s tumour.

Managed By:
4. Genentech Research and Early Development
Partner:
BioNTech AG
1. Oncology
RG6185
oncology
4. Phase 1

Description/Summary:

RG6185 (GDC-5573, HM95573) is a selective small-molecule inhibitor of the RAF family kinases designed to inhibit the MAPK pathway, which is frequently activated in human tumours and drives tumour growth.

Managed By:
4. Genentech Research and Early Development
Partner:
Hanmi Pharmaceutical
1. Oncology
RG6194
Breast Cancer
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG7159 obinutuzumab
Gazyva/Gazyvaro
hematological indications, multiple combination regimens
4. Phase 1

Description/Summary:

Obinutuzumab, GA101, is the first glycoengineered, type II, humanized anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on malignant B cells and to bind with high affinity to the cell surface in a type II configuration.

Managed By:
1. Roche Group
Partner:
Biogen Idec
1. Oncology
RG7421 cobimetinib
Cotellic
metastatic melanoma (BRAF non-mutated), second-line treatment
4. Phase 1

Description/Summary:

Cotellic (cobimetinib, RG7421) is a selective inhibitor of MEK, also known as mitogen activated protein kinase kinase (MAPKK), a key component of the RAS/RAF/MEK/ERK pathway that is frequently activated in human tumours. Inappropriate activation of the MEK/ERK pathway promotes cell growth in the absence of exogenous growth factors. A phase I trial is investigating Cotellic in combination with Tecentriq as a potential second-line treatment in patients with BRAF non-mutated metastatic melanoma previously treated with cancer immunotherapy.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7421 cobimetinib
Cotellic
Metastatic colorectal cancer, 2nd and 3rd line treatment, combination regimen with Tecentriq + Avastin
4. Phase 1

Description/Summary:

Cotellic (cobimetinib, RG7421) is a selective inhibitor of MEK, also known as mitogen activated protein kinase kinase (MAPKK), a key component of the RAS/RAF/MEK/ERK pathway that is frequently activated in human tumours. Inappropriate activation of the MEK/ERK pathway promotes cell growth in the absence of exogenous growth factors. A phase I trial of Cotellic in combination with Tecentriq (atezolizumab, anti-PDL1) and Avastin as a 2nd or 3rd line treatment in patients with advanced or metastatic colorectal cancer is ongoing.

Managed By:
1. Roche Group
Partner:
Exelixis
1. Oncology
RG7421 cobimetinib
Cotellic
Renal Cell Carcinoma (RCC), Urothelial Bladder Cancer (UC), Head and Neck Cancer
4. Phase 1

Description/Summary:

Cotellic (cobimetinib, RG7421) is a selective inhibitor of MEK, also known as mitogen activated protein kinase kinase (MAPKK), a key component of the RAS/RAF/MEK/ERK pathway that is frequently activated in human tumours. Inappropriate activation of the MEK/ERK pathway promotes cell growth in the absence of exogenous growth factors. A phase I trial is investigating Cotellic in combination with Tecentriq as a potential treatment in patients RCC, UC and H&N cancers.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7440 Ipatasertib
Triple Negative Breast cancer
4. Phase 1

Description/Summary:

Ipatasertib (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival. A phase I trial is investigating Cotellic in combination with Tecentriq and Taxane as a potential treatment in patients with TNBC.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
advanced gynecologic cancers, ovarian cancer
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase Ib trial is evaluating Tecentriq in combination with rucaparib (a small-molecule PARP inhibitor) in advanced gynecologic cancers, with a focus on ovarian cancer.

Managed By:
1. Roche Group
Partner:
Rucaparib in collaboration with Clovis
1. Oncology
RG7446 atezolizumab
Tecentriq
non-muscle-invasive bladder cancer
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase Ib/II clinical trial investigating Tecentriq as a potential treatment for non-muscle-invasive bladder cancer is ongoing.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
metastatic melanoma, combination regimen with Zelboraf, with or without Cotellic
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating atezolizumab in combination with Zelboraf (vemurafenib), with or without Cotellic (cobimetinib), for metastatic melanoma is ongoing.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
HER2-positive breast cancer
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase Ib trial evaluating Tecentriq in combination with Kadcyla (trastuzumab emtansine) or with Herceptin (trastuzumab) and Perjeta (pertuzumab), with or without chemotherapy, as appropriate, in patients with HER2-positive breast cancer is ongoing.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
metastatic castration-resistant prostate cancer
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial investigating Tecentriq combined with radium-223 dichloride in patients with prostate cancer is ongoing.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
solid tumors
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating Tecentriq for solid tumours is ongoing.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
non-small cell lung cancer, EGFR mutation-positive or ALK-positive, combination with Tarceva or Alecensa
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating Tecentriq in combination with Tarceva (erlotinib) or Alecensa (alectinib) in patients with non-small cell lung cancer is ongoing.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
solid tumors
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating Tecentriq in combination with Avastin (bevacizumab) and chemotherapy for solid tumours is ongoing.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
multiple myeloma, single-agent regimen or in combination with lenalidomide
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating atezolizumab alone and in combination with lenalidomide in multiple myeloma is planned to start in Q3 2015.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
lymphoma, combination regimen with Gazyva or tazemetostat
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating atezolizumab in combination with Gazyva (obinutuzumab) or tazemetostat (EZH2 inhibitor) in relapsed/refractory follicular lymphoma and diffuse large B cell lymphoma is ongoing.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
Pancreatic, gastric, non-small cell lung (NSCLC) and Her2+Breast Cancer (MORPHEUS platform)
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab) is a monoclonal antibody that targets PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. MORPHEUS pancreatic cancer study is testing a number of cancer immunotherapy combinations to inform future development. MORPHEUS is a phase Ib/II adaptive development platform established by Roche to assess the efficacy and safety of combination cancer immunotherapies.

Managed By:
1. Roche Group
Partner:
Cotellic in collaboration with Exelixis, BL-8040 in collaboration with BioLineRX, PEGPH20 in collaboration with Halozyme
1. Oncology
RG7461
solid tumours
4. Phase 1

Description/Summary:

RG7461 is a targeted immunocytokine combining an engineered interleukin-2 variant (IL2v) with an antibody against fibroblast activation protein (FAP), a protein expressed in several cancers. A phase I clinical trial evaluating RG7461 in solid tumours is ongoing.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
chronic lymphocytic leukemia, combination regimen with Gazyva
4. Phase 1

Description/Summary:

RG7601 is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. Gazyva, (obinutuzumab), is the first glycoengineered, type II, humanized anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on malignant B-cells and to bind with high affinity to the cell surface in a type II configuration.

Managed By:
1. Roche Group
Partner:
AbbVie, WEHI
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed/refractory myelodysplastic syndromes, combination regimen with azacitidine
4. Phase 1

Description/Summary:

Venclexta (venetoclax, RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. A phase I clinical trial is investigating Venclexta as a single agent and in combination with the hypomethylating agent azacitidine in patients with relapsed or refractory myelodysplastic syndromes.

Managed By:
1. Roche Group
Partner:
AbbVie
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory AML not eligible for cytotoxic therapy, combination regimen with Cotellic or idasanutlin
4. Phase 1

Description/Summary:

Venclexta (venetoclax, RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. A phase I clinical trial is investigating Venclexta in combination with Cotellic (cobimetinib, RG7421, selective MEK inhibitor) or with idasanutlin (RG7388, selective MDM2 antagonist) for the treatment of relapsed or refractory acute myeloid leukemia that is not eligible for cytotoxic therapy.

Managed By:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute (Venclexta); Exelixis (Cotellic)
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory chronic lymphocytic leukemia
4. Phase 1

Description/Summary:

Venetoclax is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance.

Managed By:
1. Roche Group
Partner:
Abbott, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
Relapsed or refractory Multiple Myeloma
4. Phase 1

Description/Summary:

Venclexta (venetoclax, RG7601, GDC-0199, ABT-199) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. A study of Venclexta in combination with Cotellic +/- Tecentriq in relapsed or refractory Multiple Myeloma

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7802 Cibisatamab
solid tumors
4. Phase 1

Description/Summary:

RG7802 is a bispecific antibody designed to simultaneously target carcinoembryonic antigen (CEA) expressed on tumor cells and the CD3 receptor present on T cells, triggering T cell activation, migration and tumor killing. RG7802 is currently being investigated as a potential treatment for CEA-expressing solid tumors, as a single agent and in combination with atezolizumab.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7813
solid tumors
4. Phase 1

Description/Summary:

RG7813 is a targeted immunocytokine combining an engineered cytokine (IL2v) with an antibody against carcinoembryonic antigen (CEA), a protein expressed in several cancers. A phase I clinical trial evaluating RG7813 in solid tumors is ongoing.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7813
Solid tumors, combination regimen with Tecentriq
4. Phase 1

Description/Summary:

RG7813 is a targeted immunocytokine combining an engineered cytokine (IL2v) with an antibody against carcinoembryonic antigen (CEA), a protein expressed in several cancers. RG7813 is being developed in combination with other immunotherapies, and it is currently being tested in combination with Tecentriq (atezolizumab, anti-PD-L1, RG7446).

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7827 FAP 4-1BBL FP
Solid tumours
4. Phase 1

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7828 mosunetuzumab
hematologic tumours
4. Phase 1

Description/Summary:

Anti-CD20/CD3 TDB (BTCT4465A, RG7828) is a humanised full-length T cell–dependent bispecific antibody designed to target both CD20 on B cells and CD3 on T cells. This dual-targeting antibody is designed to redirect T cells to attack cancer cells.

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG7876 selicrelumab
solid tumors, combination regimen with Tecentriq
4. Phase 1

Description/Summary:

Selicrelumab (RG7876) is a fully human (IgG2) agonistic antibody against CD40. The antibody induces T cell-driven tumor killing by activation of CD40 on antigen-presenting cells which in turn prime T cells to attack the tumor. The antibody is being developed in combination with other immunotherapies and is currently being tested in combination with Tecentriq (atezolizumab, anti-PD-L1, RG7446).

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7876 selicrelumab
solid tumours, combination regimen with vanucizumab
4. Phase 1

Description/Summary:

Selicrelumab (RG7876) is a fully human (IgG2) agonistic antibody against CD40. The antibody induces T cell-driven tumor killing by activation of CD40 on antigen-presenting cells which in turn prime T cells to attack the tumor. The antibody is being developed in combination with other immunotherapies and is also being tested in combination with vanucizumab (Ang2-VEGF biMAb, RG7221).

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6268 Entrectinib
Non-Small Cell Lung Cancer (NSCLC) testing positive for activating ROS1 rearrangements.
3. Phase 2
2019

Description/Summary:

Entrectinib, is a potent, selective CNS active tyrosine kinase inhibitor being developed for NTRK or ROS1 tumours. Activating ROS1 rearrangements are concentrated in NSCLC, accounting for 1-2% of NSCLCs. Activating rearrangements in TRK have been identified across >30 different solid tumor types, including head and neck, thyroid, sarcoma and brain.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG6268 Entrectinib
Solid Tumors positive for NTRK1 activating rearrangements
3. Phase 2
2019

Description/Summary:

Entrectinib, is a potent, selective CNS active tyrosine kinase inhibitor being developed for NTRK or ROS1 tumours. Activating ROS1 rearrangements are concentrated in NSCLC, accounting for 1-2% of NSCLCs. Activating rearrangements in TRK have been identified across >30 different solid tumor types, including head and neck, thyroid, sarcoma and brain.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7388 idasanutlin
polycythemia vera
3. Phase 2
2021+

Description/Summary:

Idasanutlin is an oral, selective, small molecule MDM2 antagonist that inhibits binding of MDM2 to p53. Blocking the MDM2-p53 interaction stabilizes p53 and activates p53-mediated cell death and inhibition of cell growth.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7421 cobimetinib
Cotellic
1st line metastatic triple-negative breast cancer
3. Phase 2
2021+

Description/Summary:

Cotellic (cobimetinib, RG7421), a selective inhibitor of MEK, also known as mitogen activated protein kinase kinase (MAPKK), is a key component of the RAS/RAF/MEK/ERK pathway, which is frequently activated in human tumors. Inappropriate activation of the MEK/ERK pathway promotes cell growth in the absence of exogenous growth factors. A phase II trial of Cotellic in combination with paclitaxel, with paclitaxel and atezolizumab, or with nab-paclitaxel and atezolizumab in patients with triple-negative breast cancer is ongoing.

Managed By:
1. Roche Group
Partner:
Exelixis
1. Oncology
RG7440 ipatasertib
triple-negative breast cancer, neoadjuvant treatment
3. Phase 2
2021+

Description/Summary:

Ipatasertib (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival.

Managed By:
4. Genentech Research and Early Development
Partner:
Array BioPharma
1. Oncology
RG7596 polatuzumab vedotin
relapsed / refractory B-cell Lymphoma
3. Phase 2
2018

Description/Summary:

Anti-CD79b is an antibody drug conjugate (ADC) that consists of a monoclonal antibody, conjugated to a potent anti-cancer agent that is selectively delivered to tumor cells.

Managed By:
1. Roche Group
Partner:
Seattle Genetics
1. Oncology
RG7596 polatuzumab vedotin
relapsed / refractory Follicular lymphoma
3. Phase 2
2020

Description/Summary:

Anti-CD79b is an antibody drug conjugate (ADC) that consists of a monoclonal antibody, conjugated to a potent anti-cancer agent that is selectively delivered to tumor cells.

Managed By:
4. Genentech Research and Early Development
Partner:
Seattle Genetics
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
HR+ breast cancer second line plus
3. Phase 2
2021+

Description/Summary:

Venclexta (venetoclax, RG7601, GDC-0199, ABT-199) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance.

Managed By:
1. Roche Group
Partner:
AbbVie
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
front-line diffuse large B cell lymphoma
3. Phase 2
2021+

Description/Summary:

Venetoclax (RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance.

Managed By:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed/refractory follicular lymphoma, combination regimen with MabThera/Rituxan
3. Phase 2
2021+

Description/Summary:

RG7601 is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. A phase II clinical trial evaluating the combination of RG7601 and MabThera/Rituxan (rituximab) in relapsed or refractory follicular lymphoma is ongoing.

Managed By:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
myelodysplastic syndromes, first-line treatment, combination regimen with azacitidine
3. Phase 2
2021+

Description/Summary:

Venclexta (venetoclax, RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. A phase II clinical trial is investigating Venclexta in combination with the hypomethylating agent azacitidine in patients with previously untreated myelodysplastic syndromes.

Managed By:
1. Roche Group
Partner:
AbbVie
1. Oncology
RG7686 codrituzumab
metastatic liver cancer
3. Phase 2
2021+

Description/Summary:

RG7686 is a first in class monoclonal humanized anti-glypican 3 antibody being developed as single agent and in combination against metastatic hepatocellular carcinoma. Its therapeutic activity in pre-clinical models was shown to take place via antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Managed By:
2. Pharma Research and Early Development
Partner:
Chugai
1. Oncology
RG3502 trastuzumab emtansine
Kadcyla
3rd line HER2-positive metastatic breast cancer
2. Phase 3

Description/Summary:

Trastuzumab emtansine (T–DM1) is a novel antibody–drug conjugate that combines the therapeutic effect of trastuzumab (the active substance of Herceptin) with intracellular delivery of DM1, a highly potent chemotherapy agent, to specifically target HER2-positive tumors.

Managed By:
1. Roche Group
Partner:
ImmunoGen
1. Oncology
RG3502 trastuzumab emtansine
Kadcyla
early HER2-positive breast cancer, adjuvant treatment, combination regimen with Perjeta
2. Phase 3
2020

Description/Summary:

Trastuzumab emtansine (T–DM1) is a novel antibody–drug conjugate that combines the therapeutic effect of trastuzumab (the active substance of Herceptin) with intracellular delivery of DM1, a highly potent chemotherapy agent, to specifically target HER2-positive tumors. Pertuzumab is a humanized monoclonal antibody designed to prevent HER2 dimerisation, a process that is believed to play an important role in the growth and formation of several different cancer types. The mechanism of action of pertuzumab is thought to be complementary to Herceptin, as both bind to the HER2 receptor but on different regions. The goal of combining pertuzumab with T-DM1 is to determine if the combination may provide a more comprehensive blockade of HER signalling pathways.

Managed By:
1. Roche Group
Partner:
Immunogen
1. Oncology
RG3502 trastuzumab-DM1
Kadcyla
HER2-positive breast cancer, adjuvant treatment
2. Phase 3
2020

Description/Summary:

Trastuzumab emtansine (T–DM1) is a novel antibody–drug conjugate that combines the therapeutic effect of trastuzumab (the active substance of Herceptin) with intracellular delivery of DM1, a highly potent chemotherapy agent, to specifically target HER2-positive tumors.

Managed By:
1. Roche Group
Partner:
ImmunoGen
1. Oncology
RG6264 Pertuzumab FDC SC
early Breast Cancer in combination with Herceptin
2. Phase 3
2020

Description/Summary:

Pertuzumab is a humanized monoclonal antibody designed to prevent HER2 dimerisation, a process that is believed to play an important role in the growth and formation of several different cancer types. The mechanism of action of pertuzumab is thought to be complementary to Herceptin, as both bind to the HER2 receptor but on different regions. The goal of combining pertuzumab with Herceptin and chemotherapy is to determine if the combination may provide a more comprehensive blockade of HER signalling pathways.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7388 idasanutlin
acute myeloid leukemia
2. Phase 3
2020

Description/Summary:

Idasanutlin is an oral, selective, small molecule MDM2 antagonist that inhibits binding of MDM2 to p53. Blocking the MDM2-p53 interaction stabilizes p53 and activates p53-mediated cell death and inhibition of cell growth.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7421 cobimetinib
Cotellic
BRAF-wild type or unresectable metastatic locally advanced melanoma first-line treatment, combination regimen with Tecentriq
2. Phase 3
2019

Description/Summary:

Cotellic (cobimetinib, RG7421) is a selective inhibitor of MEK, also known as mitogen activated protein kinase kinase (MAPKK), a key component of the RAS/RAF/MEK/ERK pathway that is frequently activated in human tumours. Inappropriate activation of the MEK/ERK pathway promotes cell growth in the absence of exogenous growth factors. A phase III trial of Cotellic in combination with Tecentriq as a first-line treatment in patients with BRAF-wild type or unresectable metastatic locally advanced melanoma is ongoing. (IMspire170)

Managed By:
1. Roche Group
Partner:
Exelixis (Cotellic), Plexxikon/Daiichi Sankyo (Zelboraf)
1. Oncology
RG7421 cobimetinib
Cotellic
BRAFv600 mutation-positive advanced melanoma, first-line treatment, combination regimen with Tecentriq + Zelboraf
2. Phase 3
2019

Description/Summary:

Cotellic (cobimetinib, RG7421) is a selective inhibitor of MEK, also known as mitogen activated protein kinase kinase (MAPKK), a key component of the RAS/RAF/MEK/ERK pathway that is frequently activated in human tumours. Inappropriate activation of the MEK/ERK pathway promotes cell growth in the absence of exogenous growth factors. A phase III trial of Cotellic in combination with Tecentriq and Zelboraf as a first-line treatment in patients with BRAF-mutated advanced melanoma is ongoing.

Managed By:
1. Roche Group
Partner:
Exelixis (Cotellic), Plexxikon/Daiichi Sankyo (Zelboraf)
1. Oncology
RG7440 ipatasertib
triple-negative breast cancer, first-line treatment
2. Phase 3
2020

Description/Summary:

Ipatasertib (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival.

Managed By:
4. Genentech Research and Early Development
Partner:
Array BioPharma
1. Oncology
RG7440 ipatasertib
castration-resistant prostate cancer
2. Phase 3
2020

Description/Summary:

Ipatasertib (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival.

Managed By:
4. Genentech Research and Early Development
Partner:
Array BioPharma
1. Oncology
RG7446 atezolizumab
Tecentriq
extensive-stage small-cell lung cancer, first-line treatment
2. Phase 3
2018

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III trial is evaluating Tecentriq in combination with chemotherapy in people with previously untreated extensive-stage small-cell lung cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
first-line non-squamous non-small cell lung cancer, combination regimen with chemotherapy and pemetrexed
2. Phase 3
2018

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being tested in a phase III clinical trial as a potential first-line treatment, in combination with chemotherapy and pemetrexed, for non-squamous non-small cell lung cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
first-line non-squamous non-small cell lung cancer, combination regimen with chemotherapy
2. Phase 3
2018

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being tested in a phase III clinical trial as a potential first-line treatment, in combination with chemotherapy, for non-squamous non-small cell lung cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
first-line non-squamous and squamous non-small cell lung cancer, PDL1-selected patients
2. Phase 3
2019

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being evaluated in a phase III clinical trial as a potential first-line treatment for patients with non-squamous or squamous non-small cell lung cancer whose tumours express PDL1.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
first-line squamous non-small cell lung cancer, combination regimen with chemotherapy
2. Phase 3
2018

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being tested in a phase III clinical trial as a potential first-line treatment, in combination with chemotherapy, for squamous non-small cell lung cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
renal cell cancer, combination regimen with Avastin
2. Phase 3
2018

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III trial evaluating atezolizumab in combination with Avastin (bevacizumab) for renal cell cancer is ongoing.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
Hepatocellular carcinoma (HCC)
2. Phase 3
2021+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III trial is evaluating Tecentriq in combination with Avastin in people with previously untreated Hepatocellular carcinoma (HCC)

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
Adjuvant squamous cell carcinoma of the head and neck (SCCHN)
2. Phase 3
2021+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III trial is evaluating Tecentriq in patients with adjuvant squamous cell carcinoma of the head and neck (SCCHN).

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
renal cell carcinoma, adjuvant treatment
2. Phase 3
2021+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
non-small cell lung cancer, adjuvant treatment
2. Phase 3
2021+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being evaluated in a phase III clinical trial as a potential adjuvant treatment, following surgery and adjuvant cisplatin-based chemotherapy, for patients with non-small cell lung cancer whose tumours express PDL1.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
first-line non-squamous non-small cell lung cancer diagnostic positive via a blood based Tumour mutational burden(TMB) assay
2. Phase 3
2021+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being tested in a phase II/III clinical trial for non-squamous non-small cell lung cancer patients who are positive via a blood based Tumour mutational burden(TMB) assay, BFAST trial.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
first-line metastatic urothelial carcinoma
2. Phase 3
2020

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III trial is evaluating Tecentriq in combination with chemotherapy or as monotherapy in patients with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
ovarian cancer, front-line treatment
2. Phase 3
2020

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III trial is evaluating Tecentriq in combination with chemotherapy and Avastin in women with newly diagnosed Stage III or IV ovarian, fallopian tube or primary peritoneal cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
castration-resistant prostate cancer
2. Phase 3
2020

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
muscle-invasive bladder cancer, adjuvant treatment
2. Phase 3
2021+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III clinical trial evaluating atezolizumab as a potential adjuvant treatment (after surgery) for muscle-invasive bladder cancer is expected to start in Q3 2015.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
adjuvant triple-negative breast cancer
2. Phase 3
2021+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being evaluated in a phase III clinical trial as a potential adjuvant treatment, in combination with paclitaxel, for triple-negative breast cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
triple-negative breast cancer, neoadjuvant treatment
2. Phase 3
2019

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III clinical trial is investigating Tecentriq in combination with nab-paclitaxel (Abraxane®) as a potential neoadjuvant (before surgery) treatment for triple-negative breast cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
metastatic triple-negative breast cancer, first-line treatment
2. Phase 3
2018

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being evaluated in a phase III clinical trial as a potential first-line treatment, in combination with nab-paclitaxel (Abraxane®), for metastatic triple-negative breast cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
metastatic triple-negative breast cancer, first-line treatment
2. Phase 3
2019

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being evaluated in a phase III clinical trial as a potential first-line treatment, in combination with paclitaxel, for metastatic triple-negative breast cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446-35 atezolizumab
Tecentriq
metastatic triple-negative breast cancer, first-line treatment with capecitabine or carboplatin / gemcitabine
2. Phase 3
2018

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being evaluated in a phase III clinical trial as a potential first-line treatment, in combination with capecitabine or carboplatin / gemcitabine, for metastatic triple-negative breast cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7596 polatuzumab vedotin
First line Diffuse Large B-cell Lymphoma
2. Phase 3
2021+

Description/Summary:

Anti-CD79b is an antibody drug conjugate (ADC) that consists of a monoclonal antibody, conjugated to a potent anti-cancer agent that is selectively delivered to tumor cells.

Managed By:
1. Roche Group
Partner:
Seattle Genetics
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
acute myeloid leukemia, first-line treatment in combination with LDAC
2. Phase 3
2021+

Description/Summary:

Venclexta (venetoclax, RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. A phase III clinical trial is investigating Venclexta in combination with low dose cytarabine in patients with previously untreated acute myeloid leukemia.

Managed By:
1. Roche Group
Partner:
AbbVie
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
acute myeloid leukemia, first-line treatment
2. Phase 3
2021+

Description/Summary:

Venclexta (venetoclax, RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. A phase III clinical trial is investigating Venclexta in combination with the hypomethylating agent azacitidine in patients with previously untreated acute myeloid leukemia who are not eligible for standard induction therapy.

Managed By:
1. Roche Group
Partner:
AbbVie
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
First-line chronic lymphocytic leukemia, combination regimen with Gazyva
2. Phase 3
2019

Description/Summary:

RG7601 is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. Gazyva, (obinutuzumab), is the first glycoengineered, type II, humanized anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on malignant B-cells and to bind with high affinity to the cell surface in a type II configuration.

Managed By:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory multiple myeloma
2. Phase 3
2019

Description/Summary:

Venclexta (venetoclax, RG7601, GDC-0199, ABT-199) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance.

Managed By:
1. Roche Group
Partner:
AbbVie
1. Oncology
RG7853 alectinib
Alecensa
ALK-positive non-small cell lung cancer, first-line treatment
2. Phase 3
2021+

Description/Summary:

Alecensa (alectinib, RG7853) is a small molecule designed to selectively target ALK (anaplastic lymphoma kinase) and to penetrate and stay in the central nervous system. Alectinib binds ALK, inhibiting downstream malignant pathways that contribute to tumorigenesis and disease progression. Alecensa is being tested in a phase II/III clinical trial for non-squamous non-small cell lung cancer patients who are ALK+, BFAST trial.

Managed By:
1. Roche Group
Partner:
Chugai
1. Oncology
RG7853 alectinib
Alecensa
ALK-positive non-small cell lung cancer, adjuvant
2. Phase 3
2021+

Description/Summary:

Alectinib is a small molecule designed to selectively target ALK (anaplastic lymphoma kinase) and to penetrate and stay in the central nervous system. Alectinib binds ALK, inhibiting downstream malignant pathways that contribute to tumorigenesis and disease progression. Alectinib is available under the brand name Alecensa.

Managed By:
1. Roche Group
Partner:
Chugai
1. Oncology
RG7446 atezolizumab
Tecentriq
first-line non-squamous non-small cell lung cancer, combination regimen with chemotherapy, with or without Avastin
1. Filed
2018

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being tested in a phase III clinical trial as a potential first-line treatment in combination with chemotherapy, with or without Avastin (bevacizumab), for non-squamous non-small cell lung cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7601-14 venetoclax
Venclexta/Venclyxto
acute myeloid leukemia, first-line treatment in combination with LDAC or HMA
1. Filed
2018

Description/Summary:

Venclexta (venetoclax, RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. Two phase 1B clinical trial are investigating Venclexta in combination with low dose cytarabine or Hypomethylating agents in patients with previously untreated acute myeloid leukemia.

Managed By:
1. Roche Group
Partner:
AbbVie

2. Immunology

2. Immunology
RG6107
paroxysmal nocturnal hemoglobinuria
4. Phase 1

Description/Summary:

RG6107 (SKY59) is a humanised complement inhibitor C5 monoclonal antibody discovered by Chugai using recycling antibody technology. By blocking cleavage of C5 to C5a and C5b, it is expected to inhibit complement activation, which is the cause of a number of diseases. As the complement system is a key innate immune defence mechanism, we plan to study the potential of this antibody in a broader range of complement-mediated diseases.

Managed By:
2. Pharma Research and Early Development
Partner:
Chugai
2. Immunology
RG6151
asthma
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
2. Immunology
RG6173
Asthma
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
2. Immunology
RG7835
autoimmune diseases
4. Phase 1

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
2. Immunology
RG7880
inflammatory diseases
4. Phase 1

Description/Summary:

RG7880 (IL22-Fc, UTTR1147A) is a recombinant human protein with potential application across multiple inflammatory and metabolic diseases.

Managed By:
4. Genentech Research and Early Development
Roche Only
2. Immunology
CHU nemolizumab
pruritus in dialysis patients
3. Phase 2

Description/Summary:

Nemolizumab (CIM331) is a humanised monoclonal antibody directed against the interleukin-31 receptor. It is currently being investigated in a phase II study as a therapy for pruritis in dialysis patients.

Managed By:
3. Chugai
Roche Only
2. Immunology
RG6149
asthma
3. Phase 2
2021+

Description/Summary:

RG6149 (anti-ST2, AMG 282) is a fully human monoclonal antibody designed to inhibit binding of interleukin-33 (IL-33) to the ST2 receptor.

Managed By:
4. Genentech Research and Early Development
Partner:
Amgen
2. Immunology
RG7159 obinutuzumab
Gazyva/Gazyvaro
lupus nephritis
3. Phase 2
2021+

Description/Summary:

Obinutuzumab, GA101, is the first glycoengineered, type II, humanised anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on B cells and to bind with high affinity to the cell surface in a type II configuration. A phase II trial is investigating obinutuzumab in patients with lupus nephritis.

Managed By:
1. Roche Group
Partner:
Biogen Idec
2. Immunology
RG7625
autoimmune diseases
3. Phase 2
2021+

Description/Summary:

Cathepsin S antagonist

Managed By:
2. Pharma Research and Early Development
Roche Only
2. Immunology
RG7845 Fenebrutinib
autoimmune diseases
3. Phase 2
2021+

Description/Summary:

RG7845 (GDC-0853) is a novel Bruton’s tyrosine kinase (BTK) inhibitor that helps block B cell proliferation and the resulting excessive immune response seen in autoimmune disorders. RG7845 binds to BTK in a novel way that is believed to increase its effectiveness. RG7845 is being investigated as a potential therapeutic option in difficult-to-treat autoimmune diseases.

Managed By:
4. Genentech Research and Early Development
Roche Only
2. Immunology
RG3648 omalizumab
Xolair
Chronic Rhinosinusitis With Nasal Polyps
2. Phase 3
2020

Description/Summary:

Xolair is a monoclonal antibody that specifically targets the antibody IgE (immunoglobulin E). In nasal polyps (NP) IgE is increased in mucosal tissue and frequently in serum.

Managed By:
1. Roche Group
Partner:
Novartis
2. Immunology
RG7413 etrolizumab
ulcerative colitis
2. Phase 3
2021+

Description/Summary:

Etrolizumab is a humanized IgG1 MAb targeting the beta 7 integrin subunit. It binds to two integrin receptors, alpha4beta7 and alphaEbeta7. These receptors are required for trafficking and retention in lymphocytes in the gastrointestinal tract and appear to play a role in inflammatory bowel diseases.

Managed By:
1. Roche Group
Roche Only
2. Immunology
RG7413 etrolizumab
Crohn's disease
2. Phase 3
2021+

Description/Summary:

Etrolizumab is a humanized IgG1 MAb targeting the beta 7 integrin subunit. It binds to two integrin receptors, alpha4beta7 and alphaEbeta7. These receptors are required for trafficking and retention in lymphocytes in the gastrointestinal tract and appear to play a role in inflammatory bowel diseases.

Managed By:
1. Roche Group
Roche Only
2. Immunology
RG1569 tocilizumab
Actemra/RoActemra
rheumatoid arthritis Acterma Auto Injector
1. Filed
2018

Description/Summary:

Actemra/RoACTEMRA (tocilizumab) is a humanised monoclonal antibody to the interleukin-6 receptor, inhibiting the activity of interleukin-6 , a protein that plays a major role in the rheumatoid arthritis inflammation process.

Managed By:
1. Roche Group
Partner:
Chugai

3. Ophthalmology

3. Ophthalmology
RG6147
geographic atrophy
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
3. Ophthalmology
RG3645 ranibizumab
Lucentis
AMD port delivery device (ranibizumab port delivery system)
2. Phase 3
2021+

Description/Summary:

Ranibizumab, the active ingredient of Lucentis, is a monoclonal antibody fragment. It is designed to bind to and inhibit VEGF (vascular endothelial growth factor), a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. A randomised comparative phase II trial is evaluating the the safety and efficacy of ranibizumab delivered via the ranibizumab port delivery system implant in patients with subfoveal neovascular age-related macular degeneration. The primary outcome measure of the trial is the time until a patient first requires a refill of the implant.

Managed By:
1. Roche Group
Partner:
Novartis, ForSight VISION4
3. Ophthalmology
RG7716 faricimab
wet age-related macular degeneration
2. Phase 3
2021+

Description/Summary:

RG7716 is a bispecific antibody developed with CrossMab technology to tightly bind VEGF-A on one arm and angiopoietin (Ang)-2 on the other arm. A randomised, active comparator-controlled phase II study is currently investigating the safety and efficacy of RG7716 in patients with choroidal neovascularisation secondary to age-related macular degeneration

Managed By:
2. Pharma Research and Early Development
Roche Only

4. Infectious Diseases

4. Infectious Diseases
RG6004
chronic hepatitis B
4. Phase 1

Description/Summary:

HBV LNA

Managed By:
2. Pharma Research and Early Development
Roche Only
4. Infectious Diseases
RG6080 nacubactam
bacterial infections
4. Phase 1

Description/Summary:

Nacubactam (RG6080, OP0595, FPI-1459) is a diazabicyclooctane (DBO) beta-lactamase inhibitor (BLI). Beta-lactamases are enzymes produced by some bacteria that make them resistant to beta-lactam antibiotics. BLIs restore and/or potentiate the activity of beta-lactam antibiotics. The combination of RG6080 with a beta-lactam antibiotic targets severe infections caused by Enterobacteriaceae, including multi-drug-resistant strains.

Managed By:
2. Pharma Research and Early Development
Partner:
Meiji and Fedora
4. Infectious Diseases
RG7854
hepatitis B infection
4. Phase 1

Description/Summary:

TLR7 agonist

Managed By:
2. Pharma Research and Early Development
Roche Only
4. Infectious Diseases
RG7861
infections caused by Staphylococcus aureus
4. Phase 1

Description/Summary:

RG7861 (anti-S. aureus TAC, DSTA4637S) is a THIOMAB™ antibiotic conjugate (TAC) that consists of a human monoclonal antibody directed against Staphylococcus aureus, conjugated to an antiobiotic agent. Anti-S. aureus TAC is designed to bind to the surface of Staphylococcus aureus bacteria.

Managed By:
4. Genentech Research and Early Development
Partner:
Seattle Genetics, Symphogen
4. Infectious Diseases
RG7907
hepatitis B infection
4. Phase 1

Description/Summary:

HBV capsid

Managed By:
2. Pharma Research and Early Development
Roche Only
4. Infectious Diseases
RG6152-1 baloxavir marboxil
influenza high risk
2. Phase 3
2019

Description/Summary:

RG6152 is an oral cap-dependent endonuclease inhibitor with broad and potent antiviral activity against seasonal influenza A and B viruses. Baloxavir marboxil is being investigated in A global Phase III study in people with flu who are at high risk of complications

Managed By:
1. Roche Group
Partner:
Shionogi
4. Infectious Diseases
RG6152 baloxavir marboxil
influenza, otherwise healthy
1. Filed
2018

Description/Summary:

RG6152 is an oral cap-dependent endonuclease inhibitor with broad and potent antiviral activity against seasonal influenza A and B viruses. Baloxavir marboxil is being investigated in A global Phase III study in people with flu but otherwise healthy

Managed By:
1. Roche Group
Partner:
Shionogi

5. CardioMetabolism

5. CardioMetabolism
CHU
hyperphosphatemia
4. Phase 1

Description/Summary:

NME

Managed By:
3. Chugai
Roche Only
5. CardioMetabolism
CHU
hypoparathyroidism
4. Phase 1

Description/Summary:

PCO371 is an orally available small molecule parathyroid hormone (PTH1) receptor agonist for hypoparathyroidism. The compound is expected to stabilize blood calcium levels without causing hypercalciuria, a major concern in conventional treatment with oral activated vitamin D and calcium.

Managed By:
3. Chugai
Roche Only
5. CardioMetabolism
RG7992
metabolic diseases
4. Phase 1

Description/Summary:

RG7992 (anti-FGFR1/KLB, BFKB8488A) is a bispecific antibody designed to mimic the metabolic hormone FGF21. It is currently being investigated as a therapy for type 2 diabetes.

Managed By:
4. Genentech Research and Early Development
Roche Only

6. Neuroscience

6. Neuroscience
RG6000
amyotrophic lateral sclerosis
4. Phase 1

Description/Summary:

RG6000 (GDC-0134) is an investigational small molecule dual leucine zipper kinase (DLK) inhibitor being evaluated for the potential treatment of amyotrophic lateral sclerosis. DLK is a neuronally-enriched kinase that is designed to mediate stress-induced cell death. DLK inhibition may exhibit neuroprotective potential.

Managed By:
4. Genentech Research and Early Development
Roche Only
6. Neuroscience
RG6042 ASO-HTT
Huntington's Disease
4. Phase 1

Description/Summary:

ASO-HTT is an antisense drug in development for the treatment of Huntington's Disease. ASO-HTT is designed to reduce the production of all forms of the huntingtin (HTT) protein, which in its mutated variant (mHTT) is responsible for Huntington's Disease.

Managed By:
2. Pharma Research and Early Development
Partner:
Ionis
6. Neuroscience
RG7816 GABA-Aa5 PAM
Autism spectrum disorder (ASD)
4. Phase 1

Description/Summary:

RG7816 is a small molecule highly selective positive allosteric modulator of the GABAA α5 receptor, which are expressed in key brain regions for autism spectrum disorder (ASD)

Managed By:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG7906
psychiatric disorders
4. Phase 1

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG1662 basmisanil
cognitive disorders
3. Phase 2
2021+

Description/Summary:

Basmisanil (RG1662) is a small molecule negative allosteric modulator that acts on a specific subset of receptors called gamma-aminobutyric acid (GABA) A receptors alpha 5, GABRA5. They are present in discrete brain regions associated with cognitive processing.

Managed By:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG6100
Alzheimer's disease
3. Phase 2
2021+

Description/Summary:

RG6100 is an investigational medicine being evaluated as a potential treatment for Alzheimer’s disease.

Managed By:
4. Genentech Research and Early Development
Partner:
AC Immune
6. Neuroscience
RG7916 Risdiplam
spinal muscular atrophy
3. Phase 2
2020

Description/Summary:

RG7916 is an investigational oral SMN2 splicing modifier being studied in the treatment of spinal muscular atrophy.

Managed By:
2. Pharma Research and Early Development
Partner:
PTC Therapeutics, SMA Foundation
6. Neuroscience
RG7935 Prasinezumab
Parkinson's disease
3. Phase 2
2021+

Description/Summary:

RG7935 is a monoclonal antibody targeting alpha-synuclein, a protein that may misfold and be involved in the pathogenesis of Parkinson's disease. It has been tested in preclinical models of synuclein-related disease and has shown a reduction of neurodegeneration.

Managed By:
2. Pharma Research and Early Development
Partner:
Prothena
6. Neuroscience
RG1450 gantenerumab
Alzheimer's disease
2. Phase 3
2021+

Description/Summary:

Gantenerumab is a fully human monoclonal antibody that binds and neutralises disease-relevant aggregated forms of amyloid-beta: those that accumulate as plaques in the brain and those which interfere with brain-cell functioning.

Managed By:
1. Roche Group
Partner:
Morphosys
6. Neuroscience
RG6168 satralizumab
neuromyelitis optica
2. Phase 3
2019

Description/Summary:

A humanized monoclonal antibody to the interleukin-6 receptor.

Managed By:
1. Roche Group
Partner:
Chugai
6. Neuroscience
RG6206
Duchenne muscular dystrophy
2. Phase 3
2020

Description/Summary:

RG6206 (BMS-986089) is a novel anti-myostatin adnectin IgG1-Fc fusion protein that binds to myostatin and inhibits its function. Myostatin is a negative regulator of muscle growth. Inhibition of myostatin has emerged as a potential therapeutic target for a number of muscle-wasting conditions, including Duchenne muscular dystrophy (DMD). A randomised, placebo-controlled, double blind phase II/III study of RG6206 is currently ongoing in ambulatory boys with DMD, regardless of genetic mutation.

Managed By:
1. Roche Group
Partner:
Bristol-Myers Squibb
6. Neuroscience
RG7314 balovaptan
autism
2. Phase 3
2021+

Description/Summary:

RG7314 is a potent and specific small molecule antagonist of the V1A vasopressin receptor, which is implicated in modulating emotional processing and key social deficits exhibited in patients with Autism spectrum disorders.

Managed By:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG7412 crenezumab
Alzheimer's disease
2. Phase 3
2021+

Description/Summary:

Crenezumab is a humanized monoclonal antibody, which binds to amyloid beta (Abeta). Abeta is the main constituent of amyloid plaque in the brains of patients with Alzheimer's disease and is proposed to be causative in the development of the disease.

Managed By:
1. Roche Group
Partner:
AC Immune

7. Other

7. Other
CHU
Endometriosis
4. Phase 1

Description/Summary:

Managed By:
3. Chugai
Roche Only

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Phase 1
Phase 2
Phase 3
Filed
Approved
00

New / Advanced

 
 

RG7596

r/r Follicular lymphoma

relapsed / refractory Follicular lymphoma

 
 

RG7601

Venclexta/Venclyxto

HR+ breast cancer

HR+ breast cancer second line plus

 
 

RG7446

Tecentriq

adjuvant TNBC, with paclitaxel

adjuvant triple-negative breast cancer

 
 

RG7853

Alecensa

Non-small cell lung cancer, adjuvant

ALK-positive non-small cell lung cancer, adjuvant

 
 

RG1569-8

Actemra/RoActemra

CRS

Cytokine release syndrome

 
 

RG3648-2

Xolair

Chronic idiopathic urticaria and asthma PFS

Chronic idiopathic urticaria and asthma pre filled syringe

 
 

RG3645

Lucentis

AMD port delivery device

AMD port delivery device (ranibizumab port delivery system)

 
 

RG7716

wAMD

wet age-related macular degeneration

 
 

RG7314

autism

autism

 
 

RG6013

hemophilia A, administered every 4 weeks

hemophilia A, administered every 4 weeks

 
 

RG6013

hemophilia A, without FVIII inhibitors

hemophilia A, patients without FVIII inhibitors

00

Removed

 
 

RG7741

solid tumors or lymphoma

solid tumors or lymphoma

 
 

RG7155

solid tumors, combination regimen with Tecentriq

solid tumors, combination regimen with Tecentriq

 
 

RG7155

solid tumors, combination regimen with RG7876

solid tumors, combination regimen with RG7876

 
 

RG7990

asthma

asthma

 
 

RG6069

fibrosis

fibrosis

 
 

RG6125

rheumatoid arthritis

rheumatoid arthritis

 
 

RG1569

Actemra/RoActemra

systemic sclerosis

systemic sclerosis

 
 

RG6029

pain

pain

 
Oncology
 
Immunology
 
Ophthalmology
 
Infectious Diseases
 
CardioMetabolism
 
Neuroscience
 
Other
Area
Product name
Description
Market

Instruments/devices planned for 2018

Central Laboratory
cobas pro integrated solution
Serum Work Area solution for medium throughput to lower high throughout labs
CE
Specialty Testing
cobas m 511
World's first fully digital morphology analyzer and cell counter
US
Workflow
CCM connectivity to cobas c513
Connection of cobas c 513 to CCM Automation System for high volume HbA1c testing
WW
Tissue Dx
BenchMark ULTRA Plus
New and differentiated Advanced Staining System
CE
Digital Pathology
VENTANA DP200
Reliable low-volume scanner with superior image quality
CE
Diabetes care
Solo Patch Pump
Small and tubeless insulin delivery device operated through a remote control which includes a blood glucose meter
CE

Tests/Assays planned for 2018

Endocrinology
IGFBP3
Completion of the existing growth hormone menu of hGH and IGF-1
CE
Infectious Diseases
Zika IgG
Highly specific immunoassay for the in vitro qualitative detection of IgG antibodies to Zika virus in human serum and plasma
CE
Microbiology
cobas CT/NG
Highest throughput CT/NG test on the market with workflow efficiency benefits
US
cobas 6800/8800 MTB/MAI
High volume solution for MTB/MAI testing; efficient approach to disease management (mixed testing) for infectious disease
CE
Virology
Plasma Separation Card
Card-like sample collection device; separates plasma from whole blood; for use with CAP/CTM HIV- 1 & cobas HIV-1 (6800/8800)
CE
Sequencing
AVENIO FFPET RUO oncology kits
3 separate tissue based assay kits for solid tumors
WW

Software

Decision Support
NAVIFY Tumor Board v 1.x
EMR integration
WW

Area
Market

WW - Worldwide.
EU - European Union.
US - United States.
* - Achieve commercial readiness, dependent on Pharma label and approval.