Roche, a leader in research-focused healthcare, announced that more than 45 abstracts featuring eight of its approved or investigational medicines will be presented during the 57th American Society of Haematology (ASH) Annual Meeting from December 5-8 in Orlando. The abstracts include more than 15 oral presentations across a broad range of molecular targets and combinations, as well as different clinical endpoints that Roche is exploring in various blood diseases and lines of treatment.
“Our data at ASH this year showcase the evolution of our haematology portfolio and represent potential future approaches to helping people with blood cancers and blood disorders,” said Sandra Horning, M.D., chief medical officer and head of global product development.
“We’re particularly excited about studies evaluating new combinations with Gazyva/Gazyvaro and venetoclax, as well as studies examining the potential clinical significance of minimal residual disease negativity.”
Data for Gazyva/Gazyvaro include results from combination studies such as the phase IIIb GREEN study and the pivotal CLL11 and GADOLIN studies. GREEN results will include data for Gazyva/Gazyvaro in combination with bendamustine in previously untreated chronic lymphocytic leukemia (CLL). Roche will also share updated results from the phase III CLL11 study, which formed the basis of the Gazyva/Gazyvaro approval in previously untreated CLL in combination with chlorambucil, and further data from the pivotal phase III GADOLIN study for the investigational use of Gazyva/Gazyvaro in patients with indolent non-Hodgkin’s lymphoma (NHL) that is refractory to MabThera/Rituxan (rituximab)-based treatment, that add to the positive results presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June this year.
Roche will also present findings from multiple studies that suggest a potential role for minimal residual disease (MRD)-negativity in the treatment of certain blood cancers. In collaboration with AbbVie, Roche will share new data for investigational medicine venetoclax as a monotherapy or in combinations across a number of blood cancers, including CLL, non-Hodgkin’s lymphoma (NHL), multiple myeloma (MM) and acute myeloid leukemia (AML). Data will also be shown for investigational medicine ACE910, which was recently granted breakthrough therapy designation by the US Food and Drug Administration (FDA) for the prophylactic treatment of people who are 12 years or older with haemophilia A with factor VIII inhibitors.
The table below contains key abstracts featuring Roche medicines that will be presented.
Separately, the FDA has accepted for priority review the company's supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro in the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to a rituximab-containing regimen, based on GADOLIN study results. Marketing applications for Gazyva/Gazyvaro have also been submitted to other health authorities, including the European Medicines Agency, for approval consideration in the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. In addition, AbbVie has submitted a New Drug Application (NDA) for venetoclax to the FDA under breakthrough therapy designation, based in part on results of the pivotal phase II M13-982 study evaluating venetoclax in people with relapsed/refractory CLL harboring the 17p deletion. Roche and AbbVie announced positive top-line results from this study earlier this year.