Karyopharm's Selinexor Shows Promise in Myelofibrosis, Phase 3 Data Expected in 2H 2025
核心洞察
Karyopharm Therapeutics anticipates top-line results from its Phase 3 SENTRY trial of selinexor plus ruxolitinib for JAKi-naïve myelofibrosis (搜索) in the second half of 2025.
The SENTRY trial updated its co-primary endpoint to absolute mean change in total symptom score (Abs-TSS) and increased the sample size to 350 patients.
Preliminary 2024 results show total revenue of approximately $145 million, with XPOVIO net product revenue reaching $113 million for Karyopharm.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is focusing on myelofibrosis (搜索) treatment with its Phase 3 SENTRY trial of selinexor in combination with ruxolitinib. The company expects top-line data in the second half of 2025 and aims to complete enrollment in the first half of the year. This trial could potentially redefine the standard of care for patients with JAK (搜索) inhibitor (JAKi)-naïve myelofibrosis.
SENTRY Trial Details
The Phase 3 SENTRY trial (NCT04562389) is evaluating a once-weekly 60 mg dose of selinexor combined with twice-daily ruxolitinib, compared to ruxolitinib alone, in JAKi-naïve patients with myelofibrosis (搜索). The trial has been updated to include absolute mean change in total symptom score (Abs-TSS) as a co-primary endpoint, alongside spleen volume reduction ≥35% (SVR35) at week 24. The sample size has been increased to approximately 350 patients to enhance statistical power.
Richard Paulson, President and Chief Executive Officer of Karyopharm, stated, "Our top strategic objective for 2025 is to deliver on the transformative opportunity to redefine the standard of care in myelofibrosis (搜索), with top-line results from our Phase 3 SENTRY trial on-track for the second half of this year."
Financial Highlights and XPOVIO Performance
Karyopharm announced preliminary unaudited full-year 2024 total revenue of approximately $145 million, with U.S. XPOVIO (selinexor) net product revenue reaching approximately $113 million. Demand for XPOVIO remained consistent in 2024 compared to 2023, with growth in the second half of the year in both community and academic settings.
Selinexor in Multiple Myeloma and Endometrial Cancer
Selinexor continues to be evaluated in multiple myeloma (搜索), with updated clinical data from Phase 2 STOMP (NCT02343042) and XPORT-MM-028 (NCT04414475) trials showing a median progression-free survival of 18.4 months with the SPd (selinexor, pomalidomide, dexamethasone) regimen. Enrollment is complete for the Phase 3 XPORT-MM-031 trial (EMN29; NCT05028348), an all-oral combination of SPd40 in previously treated multiple myeloma patients.
For endometrial cancer (搜索), Karyopharm is in discussions with the FDA regarding the Phase 3 XPORT-EC-042 trial (NCT05611931) in light of the evolving treatment landscape. An update on the endometrial cancer program is expected in the first quarter of 2025.
Other Pipeline Developments
Karyopharm's KPT-9274 (padnarsertib), a dual inhibitor of PAK4 and NAMPT, received Rare Pediatric Disease and Orphan Drug Designations from the FDA for rhabdomyosarcoma (搜索) and Ewing sarcoma (搜索). The company is exploring out-licensing and partnership opportunities for this asset. Additionally, Karyopharm reacquired KPT-350, a SINE compound being evaluated for neurological indications such as amyotrophic lateral sclerosis (搜索).