Karyopharm Therapeutics reported that its selinexor‑based combination with ruxolitinib achieved the primary spleen volume reduction endpoint in the Phase 3 SENTRY trial for frontline myelofibrosis, with 50% of patients in the combination arm reaching a 35% reduction in spleen volume at week 24 compared with 28% in the ruxolitinib‑only arm.
The study did not meet its second co‑primary endpoint, the average change in absolute total symptom score over 24 weeks, as symptom improvement was comparable between the two treatment arms. An exploratory overall survival analysis showed a hazard ratio of 0.43 (one‑sided p = 0.0222) favoring the selinexor combination, suggesting a potential survival benefit that will be further evaluated in the ongoing data set.
Richard Paulson, President and CEO, said, "As we enter 2026, Karyopharm is approaching a defining period marked by important upcoming clinical milestones and a continued focus on disciplined execution, positioning the Company at a potential inflection point." Dr. John Mascarenhas, professor of medicine at the Icahn School of Medicine, noted, "The results from SENTRY are an important development for patients as the combination of selinexor plus ruxolitinib meaningfully improved spleen response and we observed a promising signal in OS. Reducing spleen volume remains one of the most important treatment goals in myelofibrosis since achieving SVR35 is associated with improvement in overall survival."
Karyopharm recently completed a $30 million private placement with RA Capital Management, with an additional $44 million available upon warrant exercise, and raised approximately $9.6 million through its at‑the‑market program. The financing extends the company’s cash runway into the second quarter of 2026, although the firm continues to report a negative EBIT margin of –102.8% and negative free cash flow of –$11.82 million, underscoring ongoing liquidity pressures.
The company is also advancing other late‑stage programs, including a Phase 3 trial of selinexor in endometrial cancer (XPORT‑EC‑042) with data expected mid‑2026, and has voluntarily withdrawn the accelerated approval of its diffuse large B‑cell lymphoma indication to reallocate resources toward higher‑priority indications.
Following the announcement, Karyophys shares fell more than 12% on the day, and the stock had dropped 20.5% over the past week. Investor sentiment has been tempered by the mixed trial results, with the missed symptom endpoint and the company’s continued financial challenges weighing on market perception.
The spleen volume milestone positions Karyopharm to pursue a supplemental new drug application with the FDA for frontline myelofibrosis, while the overall survival signal and the company’s broader pipeline may enhance partnership or licensing opportunities. The mixed results also highlight the need for further data to confirm clinical benefit and to address the unmet symptom burden in this patient population.
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