- Phase III POLARIX trial showed Polivy plus R-CHP was the first treatment in two decades to significantly improve outcomes in newly diagnosed diffuse large B-cell lymphoma (DLBCL) versus the standard of care1
- Pivotal data on mosunetuzumab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, showed high response rates in relapsed or refractory follicular lymphoma (FL)2
- HAVEN 6 phase III interim data demonstrated Hemlibra’s favourable safety and efficacy profile in people with moderate or mild haemophilia A3
Results from three pivotal studies will be featured:
- First presentation of efficacy and safety data from the phase III POLARIX study as a late-breaking abstract and in the ASH press programme. POLARIX met its primary endpoint of improving progression-free survival, showing Polivy® (polatuzumab vedotin) plus MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin, and prednisone (R-CHP) reduced the likelihood of disease worsening or death, versus the standard-of-care, MabThera/Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), for people with newly diagnosed diffuse large B-cell lymphoma (DLBCL). The safety profile was comparable for Polivy plus R-CHP versus R-CHOP.1 POLARIX is being conducted in collaboration with
The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC). - Pivotal results from the phase I/II GO29781 study, presented for the first time and featured in the ASH press programme, showing mosunetuzumab, a CD20xCD3 T-cell engaging bispecific antibody immunotherapy, achieved high response rates with a manageable safety profile. These data suggest that it could be a new treatment option for people with relapsed or refractory follicular lymphoma (FL)
who have received two or more prior therapies.2 FL is the most common indolent (slow growing) form of non-Hodgkin lymphoma, a type of blood cancer, which often returns after initial therapy.4 - Interim data from the phase III HAVEN 6 study, which demonstrated the favourable safety and efficacy profile of Hemlibra® (emicizumab) in people with moderate or mild haemophilia A without factor VIII inhibitors.3 This patient population has historically not used prophylactic (preventative) treatments, likely due to delayed or missed diagnosis and a lack of treatments and treatment guidelines, meaning these patients have a significant unmet clinical need.5, 6
“For 20 years, we have remained committed to deepening our understanding of many benign and malignant blood disorders in order to better meet the urgent needs of patients with these diseases,” said
Data presented at ASH by
Further information on the key abstracts featuring
Follow
Medicine | Abstract title | Abstract number/presentation details |
Polivy | The POLARIX Study: Polatuzumab Vedotin with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (pola-R-CHP) Versus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) Therapy in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma | #LBA-1 oral presentation Session: Late-Breaking Abstracts Tuesday |
Mosunetuzumab | Mosunetuzumab Monotherapy Is an Effective and Well-Tolerated Treatment Option for Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) | #127 oral presentation Session: 623 Saturday |
Mosunetuzumab Plus Polatuzumab Vedotin Has Promising Efficacy and a Favorable Safety Profile in Patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma: Updated Results from a Phase Ib/II Study | #533 oral presentation Session: 627 Sunday | |
Mosunetuzumab in Combination with Lenalidomide Has a Manageable Safety Profile and Encouraging Activity in Patients with Relapsed/Refractory Follicular Lymphoma: Initial Results from a Phase Ib Study | #129 oral presentation Session: 623 Saturday | |
#3573 poster presentation Session: 626 Monday | ||
Glofitamab | Glofitamab Step-Up Dosing Induces High Response Rates in Patients (pts) With Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL), Most of Whom Had Failed Prior Bruton’s Tyrosine Kinase Inhibitor (BTKi) Therapy | #130 oral presentation Session: 623 Saturday |
Glofitamab (Glofit) in Combination with Polatuzumab Vedotin (Pola): Phase Ib/II Preliminary Data Support Manageable Safety and Encouraging Efficacy in Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) | #525 oral presentation Session: 626 Sunday | |
Glofitamab As Monotherapy and in Combination with Obinutuzumab Induces High Complete Response Rates in Patients (pts) with Multiple Relapsed or Refractory (R/R) Follicular Lymphoma (FL) | #128 oral presentation Session: 623 Saturday | |
Glofitamab Monotherapy Provides Durable Responses After Fixed-Length Dosing in Relapsed/Refractory (R/R) non-Hodgkin Lymphoma (NHL) Patients (pts) | #2478 poster presentation Session: 626 Sunday | |
Glofitamab Plus R-CHOP Induces High Response Rates With Minimal Cytokine Release Syndrome (CRS) in Patients (pts) with Relapsed/Refractory (R/R) Non-Hodgkin Lymphoma (NHL) and Previously Untreated (1L) Diffuse Large B-Cell Lymphoma (DLBCL): Preliminary Results From a Dose-Escalation and Safety Run-in Phase Ib Study | #2479 poster presentation Session: 626 Sunday | |
Cevostamab | Cevostamab Monotherapy Continues to Show Clinically Meaningful Activity and Manageable Safety in Patients with Heavily Pre-Treated Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from an Ongoing Phase I Study | #157 oral presentation Session: 653 Saturday |
Gazyva/Gazyvaro | Obinutuzumab Short Duration Infusion Is Preferred by Healthcare Providers and Has Minimal Impact on Patient-Reported Symptoms Among Patients with Untreated, Advanced Follicular Lymphoma | #1345 poster presentation Session: 623 Saturday |
Venclexta/Venclyxto | Molecular Responses Are Observed across Mutational Spectrum in Treatment-Naïve Higher-Risk Myelodysplastic Syndrome Patients Treated with Venetoclax Plus Azacitidine | #241 oral presentation Session: 637 Saturday |
Outcomes in Patients with Poor-Risk Cytogenetics with or without TP53 Mutations Treated with Venetoclax Combined with Hypomethylating Agents | #224 oral presentation Session: 617 Saturday | |
Chronic Lymphocytic Leukemia (CLL) Clonal Growth Rate Is Slower Following Venetoclax-Rituximab (VenR): Results from a Minimal Residual Disease (MRD) Model from the Randomized Phase 3 Murano Trial | #1551 poster presentation Session: 642 Saturday | |
Hemlibra | Emicizumab Prophylaxis in Persons with Mild or Moderate Hemophilia A: Results from the Interim Analysis of the HAVEN 6 Study | #343 oral presentation Session: 322 Sunday |
Evaluation of the Safety of Emicizumab Prophylaxis in Persons with Hemophilia A: An Updated Summary of Thrombotic Events and Thrombotic Microangiopathies | #3186 poster presentation Session: 322 Monday | |
Crovalimab | Two Currently Recruiting Randomized Phase III Trials: COMMODORE 1 and 2 Evaluating Crovalimab vs Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria with or without Current Anti–Complement Therapy | #4313 publication only |
Trial in Progress: The Randomized, Double-Blind, Placebo-Controlled Phase Ib CROSSWALK-a Trial Evaluating the Safety of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOEs) in Patients with Sickle Cell Disease (SCD) | #3108 poster presentation Session: 114 Monday | |
Trial in Progress: The Randomized, Double-Blind, Placebo-Controlled Phase IIa CROSSWALK-c Trial Evaluating the Efficacy of Crovalimab As Adjunct Treatment in the Prevention of Vaso-Occlusive Episodes (VOEs) in Patients with Sickle Cell Disease (SCD) | #3111 poster presentation Session: 114 Monday |
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References
[1] Tilly H, et al. The POLARIX Study: Polatuzumab Vedotin with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (pola-R-CHP) Versus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) Therapy in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma. Presentation at: ASH Annual Meeting and Exposition; 2021
[2] Budde E, et al. Mosunetuzumab Monotherapy is an Effective and Well-Tolerated Treatment Option for Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL)
[3] Negrier C, et al. Emicizumab Prophylaxis in Persons with Mild or Moderate Hemophilia A: Results from the Interim Analysis of the HAVEN 6 Study. Presentation at ASH Annual Meeting and Exposition; 2021
[4] Fowler NH. Role of Maintenance Rituximab (Rituxan) Therapy In the Treatment of Follicular Lymphoma. Pharmacy and Therapeutics; 2011; 36:590-598.
[5] Walsh C et al. Identified unmet needs and proposed solutions in mild-to-moderate haemophilia: A summary of opinions from a roundtable of haemophilia experts. Haemophilia. 2021 February 01; 27(S1):25-32.
[6] Nissen F, et al. An Insight into clinical outcomes in mild, moderate, and severe hemophilia A (HA): A preliminary analysis of the CHESS II study.
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