Karyopharm Therapeutics (Nasdaq: KPTI) plans to submit a supplemental New Drug Application (sNDA) to the U.S. FDA in August 2026 seeking accelerated approval of selinexor plus ruxolitinib for patients with myelofibrosis and will request Priority Review.According to Karyopharm, recent FDA feedback indicated spleen volume reduction ≥35% (SVR35) appears to qualify as a reasonably likely surrogate endpoint to support use of the accelerated approval pathway. The sNDA will rely on Phase 3 SENTRY topline data, including statistically significant SVR35 at week 24, a promising overall survival signal, reductions in variant allele frequency, and the overall safety dataset. Long-term overall survival from the ongoing SENTRY trial, which randomized 353 JAK inhibitor–naïve myelofibrosis patients 2:1 to selinexor plus ruxolitinib versus placebo plus ruxolitinib, is planned to verify clinical benefit.

The combination of selinexor plus ruxolitinib met the first co-primary endpoint demonstrating a statistically significant improvement of spleen volume reduction (SVR35) of 49.8% for the combination arm vs 28% for the control arm at week 24. Post-hoc analysis from the phase 3 SENTRY trial suggests SVR35 may predict overall survival (OS); new data from the […]

–New Data will Highlight a Post-Hoc Analysis from Phase 1 Portion of SENTRY Trial that Indicates Achievement of SVR35 with Selinexor plus Ruxolitinib May Predict Overall Survival–. NEWTON, Mass., June 2, 2026/ PRNewswire/-- Karyopharm Therapeutics Inc., a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that its...

Incyte (NASDAQ:INCY) reported Phase 1 data for INCA033989, a mutCALR-targeted monoclonal antibody, showing rapid spleen-volume and symptom reductions and anemia improvements in myelofibrosis (data cut-off Sept 25, 2025). As monotherapy (n=36 evaluable at Week 24) SVR25 was 41.7% and SVR35 33.3%; higher responses were seen in JAK‑naïve patients. Anemia response occurred in 56% (14/25) with 40% major responses. Most patients showed reductions in mutCALR VAF and bone marrow mutCALR+ progenitors. No dose‑limiting toxicities; MTD not reached. Registrational program planned for 2026.

Selinexor plus ruxolitinib met the SVR co-primary end point but missed the symptom score end point in the phase 3 SENTRY trial in myelofibrosis.

Die Kombination aus Selinexor und Ruxolitinib erreichte den ersten koprimären Endpunkt und zeigte in Woche 24 eine statistisch signifikante Verbesserung der Milzvolumenreduktion (SVR35) von 49,8 % in der Kombinationsgruppe gegenüber 28 % in der Kontrollgruppe. Eine Post-hoc-Analyse der...

The combination of selinexor plus ruxolitinib met the first co-primary endpoint demonstrating a statistically significant improvement of spleen volume reduction (SVR35) of 49.8% for the combination arm vs 28% for the control arm at week 24. Post-hoc analysis from the phase 3 SENTRY trial...

– While Similar Symptom Improvement Was Observed Across the Two Arms Relative to Baseline, SENTRY Did Not Meet its Second Co-Primary Endpoint of Abs-TSS – – SENTRY Demonstrated a Rapid and Near Doubling of Patients Achieving SVR35 at Week 24, versus Ruxolitinib – – Promising Overall...