The FINANCIAL — Roche on December 7 announced new, positive data from the Phase II M13-982 study of venetoclax, an investigational medicine being developed in partnership with AbbVie. Results of the study showed a clinically meaningful reduction in the number of cancer cells (overall response rate, ORR) in 79.4 percent of people with previously treated (relapsed or refractory) chronic lymphocytic leukaemia (CLL) with 17p deletion. No unexpected safety signals were reported for venetoclax.
“The high response rates, including complete responses, and duration of response demonstrate the potential of venetoclax to help people with this hard-to-treat type of leukaemia,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “This is a patient population that has very few treatment options, and we are working with AbbVie to bring this new option to people as quickly as possible.”
These pivotal data from the Phase II M13-982 study were featured in the official press program of the 57th American Society of Hematology (ASH) Annual Meeting in Orlando on Sunday, December 6, and will be presented during the Late-Breaking Abstracts Session on Tuesday, December 8, at 7:30 A.M. EST by Dr. Stephan Stilgenbauer, University of Ulm, Germany (Abstract #LBA6). The results show:
The study met its primary endpoint, with an ORR of 79.4 percent with venetoclax, as assessed by an independent review committee (IRC). In addition, 7.5 percent of people achieved a complete response with or without complete recovery (complete response without normal blood counts) in the bone marrow (CR/CRi).
Forty-five people had an assessment for minimal residual disease (MRD) in the blood. Notably 18 people (17 percent of the total, 21 percent of responders) achieved MRD-negativity, meaning no cancer could be detected using a specific test. Ten of these 18 people also had bone marrow assessments and six were MRD-negative.
At one year, 84.7 percent of all responses and 94.4 percent of MRD-negative responses were maintained. The one-year progression-free survival (PFS) and overall survival (OS) rates were 72 percent and 86.7 percent, respectively.
No unexpected safety signals were reported. The most common Grade 3-4 adverse events were low white blood cell count (40 percent), low red blood cell count (18 percent), and low platelet count (15 percent). Grade 3 or higher infection occurred in 20 percent of people. Laboratory tumour lysis syndrome was reported in five people; none had clinical consequences.
Data for venetoclax as a monotherapy or in combinations with other medicines across multiple blood cancers, including CLL, non-Hodgkin’s lymphoma (NHL), multiple myeloma (MM) and acute myeloid leukaemia (AML), will also be presented during the ASH Annual Meeting.
Separately, positive results in people with CLL included in the Phase I M12-175 study of venetoclax were published online today in the New England Journal of Medicine. The findings support the potential of venetoclax monotherapy for people with relapsed or refractory CLL, including those with 17p deletion.
AbbVie has submitted a New Drug Application (NDA) for venetoclax to the U.S. Food and Drug Administration (FDA) under breakthrough therapy designation (BTD), based in part on results of the M13-982 study. Venetoclax received BTD from the FDA earlier this year for the treatment of people with relapsed or refractory chronic lymphocytic leukaemia harbouring the 17p deletion. AbbVie has also submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA). Submissions to other regulatory authorities around the world are planned in 2016.
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