Roche to present new data across 16 blood disorders at the ASH 2020 Annual Meeting

The FINANCIAL — Roche  today announced that new data for its approved and investigational medicines will be presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition from 5 – 8 December 2020. Eleven Roche medicines will be featured in more than 80 abstracts, including 22 oral presentations. With studies spanning 16 blood disorders, including non-Hodgkin lymphoma (NHL), leukaemia, multiple myeloma (MM) and haemophilia A, these data highlight the strength and breadth of Roche’s haematology portfolio and pipeline, and commitment to developing innovative treatment solutions for patients in need.

“We have one of the largest clinical development programmes in malignant and non-malignant haematology and we continuously seek to improve patient outcomes by exploring new therapeutic mechanisms, combinations and clinical trial endpoints,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Our data reflect our ongoing commitment to following the science and improving the lives of patients with some of the most difficult-to-treat blood disorders.”

Building on its 20-year legacy in antibody engineering, Roche is exploring novel mechanisms of action for immunotherapies including T-cell engaging bispecific antibodies. Data on three investigational bispecifics will be presented, including:

• Progress from Roche’s CD20xCD3 bispecific antibody development programmes, including updated results for mosunetuzumab in relapsed or refractory (R/R) follicular lymphoma and early data in first-line diffuse large B-cell lymphoma (DLBCL). Additionally, data demonstrating high response rates with step-up dosing of glofitamab in people with R/R NHL will be presented.
• First clinical safety, efficacy and biomarker data from cevostamab (BFCR4350A), a first-of-its-kind FcRH5xCD3 bispecific antibody targeting FcRH5 on myeloma cells and CD3 on T-cells, will be presented, with initial results from the ongoing phase I GO39775 dose-escalation study in people with heavily pre-treated R/R MM.

Roche will also be sharing longer-term data, including results on novel clinical trial endpoints, that support the known efficacy and safety of its established medicines, including:

• Three year follow-up data from the pivotal phase III HAVEN study programme (HAVEN 1-4 studies), reinforcing the efficacy and safety profile of Hemlibra® (emicizumab) in people with haemophilia A with and without factor VIII inhibitors.
• Results from the first interim analysis of the European Haemophilia Safety Surveillance database, examining real-world data to monitor the ongoing safety of Hemlibra in people with haemophilia A with and without factor VIII inhibitors.
• Results on fixed-duration, chemotherapy-free combinations in chronic lymphocytic leukaemia (CLL), including five-year analysis of the phase III MURANO study, investigating Venclexta®/Venclyxto® (venetoclax) plus MabThera®/Rituxan® (rituximab) in R/R CLL, with updates on minimal residual disease and long-term outcomes analysis. Venclexta/Venclyxto is being developed by AbbVie and Roche.
• Updated results from the phase Ib/II randomised GO29365 study of fixed-duration Polivy® (polatuzumab vedotin), plus bendamustine and MabThera/Rituxan, in people with R/R DLBCL, including preliminary results from a single-arm extension cohort of 106 additional patients.

Key abstracts featuring Roche medicines that will be presented at ASH can be found in the table below.