Roche to present clinical data from six different medicines at ASH

Basel, 05 December 2014

Presentations include data on Roche’s broad portfolio of hematology medicines as well as emerging investigational agents including ACE910 (RG6013) in hemophilia A

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data on four investigational medicines and investigational uses for two approved hematology medicines will be presented during the 56th American Society of Hematology (ASH) Annual Meeting, which starts on 6 December. Of the 49 abstracts representing the breadth and depth of Roche’s hematology portfolio, nine have been accepted for oral presentation during the meeting.

“We are excited about our contribution to ASH this year because we are presenting data across a range of diseases and treatment settings, including combinations with Gazyva in a variety of blood cancers,” said Sandra Horning MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Blood diseases go beyond the oncology setting, and we will provide an update on our investigational hemophilia A medicine, ACE910, which is being developed to improve outcomes for people with this rare but serious life- long condition.”

Data to be presented at ASH in part focus on Roche’s anti-CD20 medicines, Gazyva®/Gazyvaro® (obinutuzumab) and MabThera®/Rituxan® (rituximab). Results from the maintenance phase of the phase Ib study (GAUDI), investigating Gazyva in combination with chemotherapy or bendamustine in follicular lymphoma as well as preliminary safety results from the phase IIIb study (GREEN) of Gazyva alone or in combination with chemotherapy for previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL) will be featured. In addition to updated data on the use of MabThera in CLL, results from the phase Ib (SAWYER) study of MabThera subcutaneous in previously untreated CLL will be available.

Beyond Roche’s anti-CD20 medicines, data from multiple studies will be shown for venetoclax (GDC- 0199/ABT-199), an investigational BCL-2 inhibitor being developed in collaboration with AbbVie, across a range of blood cancers. Roche will also present new data on the investigational MDM2 antagonist RG7388 and updated data on the anti-CD79b antibody drug conjugate polatuzumab vedotin.

Data from a phase Ib study of ACE910 in people with hemophilia A, including those who have developed inhibitors against factor VIII, will also be presented. ACE910 is an investigational bispecific antibody allowing for subcutaneous administration. ACE910 was initially developed by Chugai Pharmaceutical Co., Ltd. and was opted into by Roche Pharma Research and Early Development earlier in 2014.

Overview of key presentations featuring Roche medicines
MedicineDescription of studyAbstract number

ACE910 (RG6013)


Safety and Prophylactic Efficacy Profiles of ACE910, a Humanized Bispecific Antibody Mimicking the FVIII Cofactor Function, in Japanese Hemophilia A Patients Both without and with FVIII inhibitors: First-in-Patient Phase 1 Study



Gazyva/Gazyvaro (investigational use)Obinutuzumab (GA101) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or bendamustine for the first-line treatment of follicular NHL: final results from the maintenance phase of the phase Ib GAUDI study



Gazyva/Gazyvaro (investigational use)Preliminary safety results from the phase IIIb GREEN study of obinutuzumab (GA101) alone or in combination with chemotherapy for previously untreated or R/R CLL



Gazyva/Gazyvaro (investigational use)A phase Ib study of obinutuzumab combined with lenalidomide for relapsed/refractory follicular B-cell lymphoma



MabThera/Rituxan (investigational use)Value of minimal residual disease (MRD) negative status at response evaluation in chronic lymphocytic leukemia (CLL): a review of response of two phase III studies of the German CLL Study Group (GCLLSG)




(investigational use)

Non-inferior pharmacokinetics (PK) and comparable safety and response rates for subcutaneous (SC), compared with intravenous (IV), rituximab in combination with fludarabine and cyclophosphamide (FC) in patients (Pts) with untreated CLL: part 2 of the phase Ib SAWYER study (BO25341)



Polatuzumab vedotin (investigational)Updated results of a phase II randomized study (ROMULUS) of polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed/refractory non-Hodgkin lymphoma





Phase 1/1b study of RG7388, a potent MDM2 antagonist, in acute myelogenous leukemia (AML) patients (pts)



Venetoclax (investigational)A Phase 2 Study of ABT-199 (GDC-0199) in Patients with Acute Myelogenous Leukemia (AML)



Venetoclax (investigational)Determination of Recommended Phase 2 Dose of ABT-199 (GDC-0199) Combined with Rituximab (R) in Patients with Relapsed / Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)



Venetoclax (investigational)The BCL-2 Inhibitor ABT-199 (GDC-0199) in Combination with Bendamustine and Rituximab in Patients with Relapsed or Refractory Non-Hodgkin’s Lymphoma



Venetoclax (investigational)Preliminary Results of a Phase 1b Study (GO28440) Combining GDC-0199 (ABT-199) with Bendamustine/Rituximab in Patients with Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia



Venetoclax (investigational)Preliminary results of a phase 1b study (GP28331) combining GDC-0199 (ABT-199) and obinutuzumab in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL)



About Roche in hematology

For more than 20 years, Roche has been developing medicines with the goal of redefining treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood.

In addition to approved products MabThera/Rituxan and Gazyva, Roche’s pipeline of investigational hematology medicines includes the antibody-drug conjugate polatuzumab vedotin, a small molecule antagonist of MDM2 and, in collaboration with AbbVie, the small molecule BCL-2 inhibitor venetoclax.

Furthermore, Roche’s dedication to developing novel molecules in hematology expands beyond oncology, with the development of the investigational hemophilia A treatment ACE910.

About Roche in Oncology

Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anticancer chemotherapy drug, 5-Flourouracil (5-FU), to patients in 1962. Roche remains committed to developing innovative medicines and diagnostics for cancer.

The Roche Group’s portfolio of innovative cancer medicines includes Avastin (bevacizumab), Erivedge (vismodegib), Gazyva/Gazvyaro (obinutuzumab), Herceptin (trastuzumab), Kadcyla (trastuzumab emtamsine), MabThera/Rituxan (rituximab), Perjeta (pertuzumab), Tarceva (erlotinib), Xeloda (capecitabine) and Zelboraf (vemurafenib). In addition, the Group has a robust oncology pipeline focusing on new therapeutic targets and novel combination strategies.

In addition to its innovative portfolio of cancer medicines, Roche is constantly developing new diagnostic tests that will have a significant impact on disease management for cancer patients. Within Roche there are more than 350 pharma and diagnostics collaborations, most of which are in the field of oncology. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreatic and lung cancer, as well as a range of tissue and molecular oncology tests that contribute to personalised cancer care today, Roche is leading a new era of innovation in the fight against cancer.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty- four medicines developed by Roche are included in the WHO Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit

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