**Karyopharm Therapeutics Adjusts Co-Primary Endpoint for Phase 3 Clinical Trial****

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On October 31, 2024, Karyopharm Therapeutics Inc. (NASDAQ: KPTI) made significant announcements regarding adjustments to the co-primary endpoints for its Phase 3 clinical trial. The trial, focused on myelofibrosis, will now evaluate a once-weekly dose of 60 mg of selinexor in combination with twice-daily ruxolitinib versus placebo plus ruxolitinib in JAKi naive patients with platelet counts exceeding 100 x 10^9 /L.

The change in the co-primary endpoint was disclosed following feedback from the U.S. Food and Drug Administration. Total symptom score improvement of ≥ 50%, originally one of the co-primary endpoints, will now be replaced with absolute total symptom score (Abs-TSS). Abs-TSS measures the average improvement in patient symptom scores over 24 weeks relative to the baseline symptom score.

The adjustments come with promising data from Karyopharm’s Phase 1 trial, demonstrating significant improvements. In the Phase 1 trial evaluating the selinexor and ruxolitinib combination, 79% of JAKi naive myelofibrosis patients achieved the spleen volume response rate ≥ 35%, while an approximate 18.5 point improvement in Abs-TSS was noted at week 24 compared to baseline.

Dr. Raajit Rampal, Director of the Center for Hematologic Malignancies, expressed optimism regarding the Phase 3 trial. He highlighted the meaningful improvements observed in Abs-TSS and the doubled spleen volume response rate compared to historical data from JAKi monotherapy.

Reshma Rangwala, MD, PhD, Chief Medical Officer at Karyopharm, emphasized the company’s confidence in the Phase 3 SENTRY trial. The adjustments, along with an increased sample size and positive Phase 1 trial results, are expected to enhance the trial’s success. Top-line data from the Phase 3 trial is anticipated in the second half of 2025.

The company will be hosting a conference call on the developments related to the Phase 3 SENTRY trial on October 31, 2024, at 8:00 a.m. Eastern Time, featuring Drs. Raajit Rampal and John Mascarenhas.

The adjustments in the co-primary endpoint and the continuing progression of the Phase 3 trial represent significant steps forward in the development of novel cancer therapies by Karyopharm Therapeutics Inc.

Reference:
Effective Date: October 31, 2024, Source: EDGAR, Company: Karyopharm Therapeutics, Headline: Karyopharm Therapeutics Adjusts Co-Primary Endpoint for Phase 3 Clinical Trial

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Karyopharm Therapeutics’s 8K filing here.

About Karyopharm Therapeutics

Karyopharm Therapeutics Inc, a commercial-stage pharmaceutical company, discovers, develops, and commercializes drugs directed against nuclear export for the treatment of cancer and other diseases in the United States. The company discovers, develops, and commercializes novel and small molecule Selective Inhibitor of Nuclear Export (SINE) compounds that inhibit the nuclear export protein exportin 1 (XPO1).