Roche RHHBY announced positive data from a phase II study, M13-982, on its oncology candidate, venetoclax.
Roche is developing venetoclax with AbbVie ABBV for the treatment of patients suffering from previously treated chronic lymphocytic leukemia (CLL) with a 17p deletion.
Results of the study showed that treatment with venetoclax resulted in a clinically meaningful reduction in the number of cancer cells. The study met its primary endpoint with an overall response rate of 79.4% as assessed by an independent review committee.
Data from the study were announced at the official press program of the 57th American Society of Hematology (ASH) Annual Meeting in Orlando.
Roche will also present data on venetoclax as a monotherapy or in combination with other drugs for CLL, non-Hodgkin’s lymphoma, multiple myeloma and acute myeloid leukemia.
We remind investors that the FDA granted Breakthrough Therapy designation to venetoclax earlier in 2015 for the treatment of people with relapsed or refractory CLL harboring the 17p deletion. AbbVie has submitted a New Drug Application (NDA) for venetoclax to the FDA under Breakthrough Therapy designation. The company has also filed for an approval of the drug in Europe.
Meanwhile, results from a phase I study, M12-175, on venetoclax were published online in the New England Journal of Medicine.
Separately, Roche announced data from the CLL11 study on its leukemia drug, Gazyva. The study showed that Gazyva plus chlorambucil reduced the risk of disease worsening or death by more than half compared to Rituxan plus chlorambucil.
We remind investors that Gazyva was approved by the FDA for use in combination with chlorambucil in people with previously untreated chronic lymphocytic leukemia in 2013 under Breakthrough Therapy designation.
The drug was also approved by the European Commission in Jul 2014 under the brand name, Gazyvaro, for the treatment of patients with previously untreated CLL, who have co-existing medical conditions (comorbidities) that make them unsuitable for an intensive therapy (a full-dose fludarabine-based therapy).
Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise, which includes drugs like Herceptin, Perjeta and Kadcyla.
Approval of new drugs for leukemia will further broaden its oncology portfolio and somewhat offset the loss of revenues resulting from the generic competition for Xeloda, Zelboraf and Pegasys.
Roche currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the healthcare sector include AstraZeneca PLC AZN and Eli Lilly and Co. LLY. While AstraZeneca sports a Zacks Rank #1 (Strong Buy), Eli Lilly has a Zacks Rank #2 (Buy).
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