Karyopharm gains after changes to late-stage trial

seekingalpha
2024-11-01

Shidlovski

Karyopharm (NASDAQ:KPTI) traded higher on Thursday after the company said, based on feedback from the FDA, it has redesigned its Phase 3 SENTRY Trial for its lead asset selinexor in patients with myelofibrosis, a rare form of bone marrow cancer.

Newton, Massachusetts-based Karyopharm (NASDAQ:KPTI) said it will introduce a clinical measure called Absolute Total Symptom Score (Abs-TSS) as one of SENTRY's co-primary endpoints in place of Total Symptom Score Improvement of ≥ 50% (TSS50).

SENTRY is a pivotal trial designed to evaluate selinexor in combination with JAK inhibitor ((JAKi)) ruxolitinib, marketed by Incyte (INCY) as Jakafi, in about 350 JAKi-naïve patients with myelofibrosis.

The company said selinexor plus ruxolitinib has led to an average Abs-TSS improvement of 18.5 points over 24 weeks in nine patients who were evaluable for efficacy in a Phase 1 trial.

"Our confidence in the success of our Phase 3 SENTRY trial increases based on the change in the co-primary endpoint to Abs-TSS, the increased sample size, and the data previously presented from our Phase 1 trial," said Karyopharm's (KPTI) medical chief Reshma Rangwala.

"Based upon strong enrollment, we remain on track to report top-line results in the second half of 2025."

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