Karyopharm Therapeutics (NASDAQ:KPTI) slips 1% premarket on heels of Phase 2b data on XPOVIO (selinexor), combined with low-dose dexamethasone, in patients with heavily pretreated triple class refractory multiple myeloma (MM). The results were just published in the online edition of the New England Journal of Medicine.
The study, called STORM, showed a response rate of 26%. Median overall survival (OS) was 15.6 months in the 39% of patients who experienced at least a minimal response compared to 1.7 months in those who progressed or were not evaluable for response. Mean duration of response was only 4.4 months, however.
On the safety front, the most common treatment-emergent adverse events (TEAEs) were thrombocytopenia (low blood platelets) (73%), fatigue (73%), nausea (72%) and anemia (67%). The most common serious/life-threatening TEAEs were thrombocytopenia (59%), anemia (44%), hyponatremia (low blood sodium) (22%) and neutropenia (low blood neutrophils) (21%). The treatment discontinuation rate was 27%. 53% of patients had a reduction in XPOVIO dosage while 65% had their dosage interrupted. The rate of fatal adverse reactions was almost 9%.
Last month, the FDA granted accelerated approval of XPOVIO for adults with relapsed/refractory MM who received at least four prior lines of therapy and whose disease was refractory to at least two proteasome inhibitors, at least two immunomodulatory agents and an anti-CD38 monoclonal antibody. The company will need to conduct a confirmatory study to gain full approval.
The company’s marketing application in Europe is currently under EMA review with a decision expected by year-end or early 2020.
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