Roche to present new data at ASH 2023 showcasing breadth of haematology portfolio spanning 10 different types of blood disorders

Basel, 2 November 2023 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it will be presenting more than 45 abstracts at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, spanning 10 haematology indications.

New data reflect Roche’s commitment to advancing treatment standards even further to help improve the lives of people with blood disorders. This includes new areas, as well as diseases where its medicines have already changed the standard of care, such as haemophilia A, diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). These data also support Roche’s mission to develop more convenient treatment solutions that are tailored to meet the unique needs of both healthcare professionals and patients. The 2023 ASH Meeting and Exposition will take place 9-12 December 2023, in San Diego, California.
Key presentations include:

• Longer follow-up data from the pivotal Phase II NP30179 and GO29781 studies continue to demonstrate the durability of fixed-duration Columvi® (glofitamab) and Lunsumio® (mosunetuzumab), and their potential to address the unique and diverse needs of people with lymphoma and help improve clinical outcomes. ^[1,2]
• Data from studies investigating Lunsumio and Columvi in combination with other molecules including Polivy® (polatuzumab vedotin), R-CHOP and lenalidomide, provide evidence for the potential of these novel combination regimens to optimise outcomes even further for people with DLBCL and FL across earlier treatment lines, and support further exploration of these treatments in ongoing Phase III studies. ^[3,4,5]
• Exploratory biomarker analyses from the Phase III POLARIX study of Polivy in previously untreated DLBCL which help us to further understand the different molecular subtypes of this complex and aggressive disease. ^[6,7]
• Early safety and preliminary efficacy results from a Phase I study of P-BCMA-ALLO1, a fully allogeneic chimeric antigen receptor T-cell therapy targeting B-cell maturation antigen (a protein expressed on cancerous plasma cells) for the treatment of relapsed or refractory multiple myeloma, being developed in collaboration with Poseida Therapeutics. ^[8]
• Phase III HAVEN 7 primary data provide additional evidence in infants with severe haemophilia A without factor VIII inhibitors, adding to the body of efficacy and safety data for Hemlibra® (emicizumab). ^[9]
• New patient reported outcomes and safety data from the pivotal Phase III COMMODORE clinical trial programme of crovalimab for the treatment of paroxysmal nocturnal haemoglobinuria (PNH), which is currently in review by regulatory authorities around the world. ^[10,11,12]

Further information on key abstracts featuring Roche medicines that will be presented at ASH can be found in the table below.

Medicine	Abstract title	Abstract number/ Presentation details
Columvi® (glofitamab)	A Phase III, Open-label, Multicenter, Randomized Trial Evaluating Glofitamab Monotherapy in Patients with Relapsed or Refractory Mantle Cell Lymphoma	#3052 poster presentation Session: 623 Sunday, December 10, 2023 18:00 - 20:00 PT / 03:00 – 05:00 CET [+1 day]
	Glofitamab Monotherapy in Relapsed or Refractory Large B-Cell Lymphoma: Extended Follow-Up from a Pivotal Phase II Study and Subgroup Analyses in Patients with Prior Chimeric Antigen Receptor T-Cell Therapy and by Baseline Total Metabolic Tumor Volume	#433 oral presentation Session: 626 Sunday, December 10, 2023 09:30 - 11:00 PT / 18:30 - 20:00 CET
	Glofitamab Plus R-CHOP Induces High Response Rates with a Manageable Safety Profile in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A 12-Month Analysis from a Phase Ib Study	#3085 poster presentation Session: 626 Sunday, December 10, 2023 18:00 - 20:00 PT / 03:00 – 05:00 CET [+1 day]
Lunsumio® (mosunetuzumab)	Mosunetuzumab Monotherapy Continues to Demonstrate Durable Responses in Patients with Relapsed and/or Refractory Follicular Lymphoma after ≥2 Prior Therapies: 3-Year Follow-Up from a Pivotal Phase II Study	#603 oral presentation Session: 623 Sunday, December 10, 2023 16:30 - 18:00 PT / 01:30 AM – 03:00 CET [+1 day]
	Mosunetuzumab Plus Polatuzumab Vedotin Demonstrates a Favorable Safety Profile and Efficacy in Patients (Pts) with Relapsed or Refractory (R/R) Large B-cell Lymphoma (LBCL): Primary analysis of a Phase Ib/II Study	#613 oral presentation Session: 627 Sunday, December 10, 2023 16:30 - 18:00 PT / 01:30 – 3:00 CET [+ 1 day]
	Subcutaneous mosunetuzumab is active and has a manageable safety profile in patients with previously untreated, low-tumor burden follicular lymphoma: initial results from the Phase II MorningSun study	#3029 poster presentation Session: 623 Sunday, December 10, 2023 18:00 - 20:00 PT / 03:00 – 05:00 CET [+1 day]
	Preliminary findings of a Phase Ib/II Trial Indicate Manageable Safety and Promising Efficacy for Mosunetuzumab in Combination with Lenalidomide (M+Len) in Previously Untreated (1L) Follicular Lymphoma (FL)	#605 oral Session: 623 Sunday, December 10, 2023 16:30 - 18:00 PT / 01:30 – 3:00 CET [+ 1 day]
Polivy® (polatuzumab vedotin)	Deciphering the Clinical Benefit of Pola-R-CHP versus R-CHOP in Different Genetic Subtypes Beyond Cell of Origin in the POLARIX Study	#3000 poster presentation Session: 621 Sunday, December 10, 2023 18:00 - 20:00 PT / 03:00 AM - 05:00 CET [+1 day]
	Plasma Circulating Tumor DNA (ctDNA) as an Alternative to Tissue DNA for Genotyping of DLBCL: Results from the POLARIX Study	#169 oral presentation Session: 621 Saturday, December 9, 2023 14:00 - 15:30 PT / 23:00 – 00:30 CET
P-BCMA-ALLO1 (in collaboration with Poseida Therapeutics)	Early Safety Results of P-BCMA-ALLO1, a Fully Allogeneic Chimeric Antigen Receptor T-Cell (CAR-T), in Patients with Relapsed / Refractory Multiple Myeloma (RRMM)	#3479 poster presentation Session: 704 Sunday, December 10, 2023 18:00 - 20:00 PT / 03:00 AM - 05:00 CET [+1 day]
Venclexta/Venclyxto® (venetoclax)	Response to Subsequent Novel Therapies and Time to Second Progression-Free Survival Event in the MURANO Trial in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia Previously Treated with Fixed-Dose Venetoclax Plus Rituximab	#1898 poster presentation Session: 642 Saturday, December 9, 2023 17:30 - 19:30 PT / 02:30 - 04:30 CET [+1 day]
Hemlibra® (emicizumab)	Emicizumab Prophylaxis in Infants with Severe Hemophilia A without Factor VIII Inhibitors: Results from the Primary Analysis of the HAVEN 7 Study	#505 oral presentation Session: 322 Sunday, December 10, 2023 12:00 - 13:30 PT / 21:00 – 22:30 CET
	Factor VIII Use in the Treatment of Breakthrough Bleeds in People with Moderate or Mild Hemophilia A without Factor VIII Inhibitors Receiving Emicizumab Prophylaxis: The Phase III HAVEN 6 Experience	#3999 poster presentation Session: 322 Monday, December 11, 2023 18:00 - 20:00 PT / 03:00 AM - 05:00 AM CET [+1 day]
	Pharmacodynamic Biomarkers in Infants with Hemophilia A Receiving Emicizumab in HAVEN 7	#1238 poster presentation Session: 322 Saturday, December 9, 2023 17:30 - 19:30 PT / 02:30 - 04:30 CET [+1 day]
Crovalimab	Biomarker Analyses in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Treated with Crovalimab and Eculizumab: Results from the Phase III Randomized COMMODORE 2 Trial	#4088 poster presentation Session: 508 Monday, December 11, 2023 18:00 - 20:00 PT / 03:00 AM - 05:00 CET [+1 day]
	Patient-Reported Outcomes (PROs) in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Treated with Crovalimab and Eculizumab: Results from the Phase III Randomized COMMODORE 2 and COMMODORE 1 Trials	#4090 poster presentation Session: 508 Monday, December 11, 2023 18:00 - 20:00 PT / 03:00 - 05:30 CET [+1 day]
	Safety of Crovalimab versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH): Pooled Results from the Phase III COMMODORE 1, COMMODORE 2, and COMMODORE 3 Studies	#575 oral presentation Session: 508 Sunday, December 10, 2023 16:30 - 18:00 PT / 01:30 - 03:00 CET [+1 day]

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, Tecentriq® (atezolizumab), and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

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 www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Hutchings M, et al. Glofitamab Monotherapy in Relapsed or Refractory Large B-Cell Lymphoma: Extended Follow-Up from a Pivotal Phase II Study and Subgroup Analyses in Patients with Prior Chimeric Antigen Receptor T-Cell Therapy and by Baseline Total Metabolic Tumor Volume. Presented at American Society of Hematology (ASH) virtual congress; 2023 December 10. Abstract 433.
[2] Schuster S.J, et al. Mosunetuzumab Monotherapy Continues to Demonstrate Durable Responses in Patients with Relapsed and/or Refractory Follicular Lymphoma after ≥2 Prior Therapies: 3-Year Follow-Up from a Pivotal Phase II Study. Presented at American Society of Hematology (ASH) virtual congress; 2023 December 11. Abstract 4460.
[3] Budde L.E, et al. Mosunetuzumab Plus Polatuzumab Vedotin Demonstrates a Favorable Safety Profile and Efficacy in Patients (Pts) with Relapsed or Refractory (R/R) Large B-cell Lymphoma (LBCL): Primary analysis of a Phase Ib/II Study. Presented at American Society of Hematology (ASH) virtual congress; 2023 December 10. Abstract 613.
[4] Topp M.S, et al. Glofitamab Plus R-CHOP Induces High Response Rates with a Manageable Safety Profile in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A 12-Month Analysis from a Phase Ib Study. Presented at American Society of Hematology (ASH) virtual congress; 2023 December 10. Abstract 3085.
[5] Morschhauser F, et al. Preliminary findings of a Phase Ib/II Trial Indicate Manageable Safety and Promising Efficacy for Mosunetuzumab in Combination with Lenalidomide (M+Len) in Previously Untreated (1L) Follicular Lymphoma (FL). Presented at American Society of Hematology (ASH) virtual congress; 2023 December 10. Abstract 605.
[6] Jardin F, et al. Plasma Circulating Tumor DNA (ctDNA) as an Alternative to Tissue DNA for Genotyping of DLBCL:Results from the POLARIX Study. Presented at American Society of Hematology (ASH) virtual congress; 2023 December 9. Abstract 169.
[7] Morschhauser F, et al. Deciphering the Clinical Benefit of Pola-R-CHP versus R-CHOP in Different Genetic Subtypes Beyond Cell of Origin in the POLARIX Study. Presented at American Society of Hematology (ASH) virtual congress; 2023 December 10. Abstract 3000.
[8] Kocoglu M, et al. Early Safety Results of P-BCMA-ALLO1, a Fully Allogeneic Chimeric Antigen Receptor T-Cell (CAR-T), in Patients with Relapsed / Refractory Multiple Myeloma (RRMM). Presented at American Society of Hematology (ASH) virtual congress; 2023 December 10. Abstract 3479.
[9] Pipe S, et al. Emicizumab Prophylaxis for the Treatment of Infants with Severe Hemophilia A without Factor VIII Inhibitors: Results from the Primary Analysis of the HAVEN 7 Study. Presented at American Society of Hematology (ASH) virtual congress; 2023 December 10. Abstract 505.
[10] Lundberg P, et al. Biomarker Analyses in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Treated with Crovalimab and Eculizumab: Results from the Phase III Randomized COMMODORE 2 Trial. Presented at American Society of Hematology (ASH) virtual congress; 2023 December 11. Abstract 4088.
[11] Panse J, et al. Patient-Reported Outcomes (PROs) in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Treated with Crovalimab and Eculizumab: Results from the Phase III Randomized COMMODORE 2 and COMMODORE 1 Trials. Presented at American Society of Hematology (ASH) virtual congress; 2023 December 11. Abstract 4090.
[12] Röth A, et al. Safety of Crovalimab versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH): Pooled Results from the Phase III COMMODORE 1, COMMODORE 2, and COMMODORE 3 Studies. Presented at American Society of Hematology (ASH) virtual congress; 2023 December 10. Abstract 575.

Roche Investor Relations
Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr. Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com	Dr. Gerard Tobin Phone: +41 61 68-72942 e-mail: gerard.tobin@roche.com
Investor Relations North America
Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com

 

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