Karyopharm Therapeutics Inc. (KPTI) on Tuesday reported positive topline results from its Phase 3 SENTRY trial of selinexor in combination with ruxolitinib in frontline myelofibrosis. Karyopharm shares were up more than 15% in pre-market trading.
The trial met its first co-primary endpoint, showing a statistically significant improvement in spleen volume reduction of at least 35% (SVR35) in patients treated with the combination compared with ruxolitinib alone.
At week 24, 50% of patients receiving the selinexor combination achieved SVR35, compared with 28% in the ruxolitinib-only group. The combination also showed earlier and sustained responses, with 49% achieving SVR35 at week 12 versus 20% for ruxolitinib alone, and 47% at week 36 compared with 23%.
Symptom improvement was comparable between the two groups, with patients receiving the combination reporting a 9.89-point reduction in total symptom score versus a 10.86-point reduction for ruxolitinib alone at week 24.
The company said the combination demonstrated a promising overall survival signal, with a hazard ratio of 0.43, and added that it will continue to follow survival data to maturity.
Karyopharm said it plans to meet with the U.S. Food and Drug Administration to discuss the data and a potential supplemental new drug application filing.
Karyopharm stock closed at $6.66 on Monday, down 12.71%.
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