Karyopharm Therapeutics Inc.'s (KPTI - Free Report) reported encouraging top-line results from a phase IIb study on its oncology candidate, selinexor.
The phase IIb STORM study evaluated oral selinexor, in combination with low-dose dexamethasonein, in heavily pretreated multiple myeloma (MM) patients, which refers to patients with quad-refractory disease or penta-refractory disease. The selinexor arm achieved a promising response rate, including 20.8% in the quad-refractory and 20.0% in the penta-refractory groups.
The company believes that such anti-cancer activity has not been reported by any other therapy, oral or intravenous, in such medical conditions with significant unmet need. Overall side effects of selinexor, when used with low-dose of dexamethasone, were found to be almost equally or less severe than selinexor alone.
Selinexor is a first-in-class oral selective inhibitor of the nuclear export (SINE) compound.
The data was also presented at the European Hematology Association (EHA).
Karyopharm is expanding the STORM study in different sites across the U.S. and Europe. The company is planning to enroll approximately 120 additional patients with penta-refractory multiple myeloma. This would help to determine the safety and efficacy of selinexor. The company has plans to request the FDA to grant accelerated approval for selinexor in MM, based on data from the expanded study with results expected in 2018.
Meanwhile, Karyopharm has announced plans to initiate a phase III (boston) study in early 2017 to evaluate selinexor in combination with Takeda’s MM drug Velcade and dexamethasone, versus Velcade and dexamethasone in previously treated myeloma patients.
Zacks Rank & Key Picks
Sage Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in medical drugs sector include Acerus Pharmaceuticals Corporation , BioSpecifics Technologies Corp. (BSTC - Free Report) and Corcept Therapeutics Incorporated (CORT - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy).
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