Genentech recently announced that more than 45 abstracts, including eight of its approved or investigational medicines, will be presented during the 57th American Society of Hematology (ASH) Annual Meeting in Orlando, set for Dec. 5–8. These abstracts feature more than 15 oral presentations about molecular targets and combinations, as well as other clinical endpoints that Genentech is developing in various blood diseases and lines of treatment, and of particular importance in lymphoma research.
GADOLIN studies were the main source of data in this research, particularly for Gazyva, a prescription medicine used with the chemotherapy drug chlorambucil in the treatment of chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment; and in patients with indolent non-Hodgkin’s lymphoma (NHL) refractory to Rituxan (rituximab)-based treatment. These results add positively to those presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2015.
“Our data at ASH this year showcase the evolution of our hematology portfolio and represent potential future approaches to helping people with blood cancers and blood disorders,” Sandra Horning, MD, head of Global Product Development, said in a news release. “We’re particularly excited about studies evaluating new combinations with Gazyva and Venetoclax, as well as studies examining the potential clinical significance of minimal residual disease negativity.”
The FDA has agreed to prioritize its review of the company’s supplemental Biologics License Application (sBLA) for Gazyva to treat patients with follicular lymphoma (FL) that retracted after a rituximab-containing regimen, based on the GADOLIN study results. The company has also submitted marketing applications to other health authorities, including the European Medicines Agency, for consideration of Gazyva in the treatment of patients with FL who do not respond or progress during or up to six months after treatment with rituximab or a rituximab-containing regimen.
Genentech will also present findings from several studies suggesting a potential role for minimal residual disease (MRD)-negativity in the treatment of some blood cancers. The company collaborated with AbbVie, and will reveal novel data for the investigational medicine venetoclax as a monotherapy or in combinations in chronic lymphocytic leukemia (CLL), NHL, multiple myeloma (MM) and acute myeloid leukemia (AML).