Bayer Announced Positive Data For Cancer Drug Copanlisib
Zacks Investment Research | Apr 03, 2017 04:28AM ET
Bayer Aktiengesellschaft (OTC:BAYRY) announced positive data on its experimental candidate copanlisib.
Copanlisib is, an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms.
The phase II study, CHRONOS-1, is evaluating patients suffering from relapsed or refractory indolent non-Hodgkin's lymphoma (iNHL).The study met its primary endpoint of a pre-specified objective response rate (ORR). According to the results that patient groups showed an ORR of 59.2%, with a 12% complete response (CR) rate and a median duration of response (DOR) of more than 98 weeks (687 days).
The results further showed that when intravenous copanlisib was administered at intervals then copanlisib achieved durable efficacy with a manageable safety profile. These data will be presented at the American Association for Cancer Research (AACR) 2017 Annual Meeting in Washington, D.C.
Bayer’s share price shows that the company has outperformed the Zacks classified Large Cap Pharmaceuticals industry year to date. The stock returned 10.5% compared with industry’s gain of 6%.
Per the European Society for Medical Oncology (ESMO) guidelines, the inhibition of the PI3K pathway has proven to be an effective therapeutic strategy in treating indolent lymphomas, like follicular lymphoma (FL). We note that Bayer is seeking accelerated approval of copanlisib for the treatment of relapsed or refractory FL who have received at least two prior therapies and plans to submit a New Drug Application (NDA) to the FDA.
The company has been granted Fast Track Designation by the FDA for copanlisib for this indication. In addition, copanlisib was also granted Orphan Drug Designation (ODD) by the FDA Office of Orphan Products Development in the U.S. for the treatment of FL and for the treatment of splenic, nodal, and extranodal subtypes of marginal zone lymphoma (MZL).
Zacks Rank & Stocks to Consider
Bayer currently carries a Zacks Rank #3 (Hold). Some other better-ranked stocks in the health care sector include Heska Corp. (NASDAQ:HSKA) , Retrophin, Inc. (NASDAQ:RTRX) and Galena Biopharma, Inc. (NASDAQ:GALE) . All the three companies carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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