Karyopharm Reports Mixed Results in Phase 3 SENTRY Trial for Myelofibrosis

Karyopharm Therapeutics (KPTI) announced mixed top-line results from its Phase 3 SENTRY trial evaluating selinexor in combination with ruxolitinib for patients with myelofibrosis. The trial successfully met its first co-primary endpoint, demonstrating a statistically significant reduction in spleen volume (SVR35) compared to ruxolitinib alone. However, the study failed to achieve its second co-primary endpoint regarding absolute Total Symptom Score (Abs-TSS) improvement. Despite the mixed primary outcomes, the data revealed a promising survival signal, showing a reduction in the risk of death by more than 50%. Analysts suggest that while the spleen reduction and survival data are strong, the failure to meet the symptom score endpoint introduces regulatory uncertainty for FDA approval. The company plans to engage with regulatory authorities to discuss the next steps for the selinexor development program.

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