BASEL, Switzerland
,
November 2, 2023
(press release)
–
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. Further information on key abstracts featuring Roche medicines that will be presented at ASH can be found in the table below. About Roche in haematology About Roche 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 Attachment
Key presentations include:
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]
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.
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.
[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.comDr. 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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