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ARTICLE | Clinical News

Karyopharm planning selinexor submissions in MM

April 30, 2018 11:12 PM UTC

Karyopharm Therapeutics Inc. (NASDAQ:KPTI) gained $3.06 (24%) to $16.14 in after-hours trading Monday after reporting that selinexor (KPT-330) met the primary endpoint of improving overall response rate (ORR) in the Phase IIb STORM trial to treat penta-refractory multiple myeloma. Based on the data, the company plans to submit an NDA to FDA next half seeking accelerated approval of selinexor in the indication. Karyopharm also plans to submit an MAA to EMA early next year seeking conditional approval of the candidate.

On STORM's primary endpoint, twice-weekly 80 mg oral selinexor in combination with low-dose dexamethasone led to an ORR of 25.4%, including two complete responses and 29 partial or very good partial responses. Karyopharm said the threshold to meet the endpoint was an ORR of at least 20%. Median duration of response was 4.4 months...

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