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Karyopharm stock rose 10% due to mixed Phase 3 clinical trial data
Investing.com – Karyopharm Therapeutics Inc. (NASDAQ:KPTI) stock rose 10% on Tuesday after the company announced mixed results from its Phase 3 SENTRY clinical trial, which evaluated the efficacy of selinexor combined with ruxolitinib in first-line myelofibrosis patients.
The trial met its first co-primary endpoint, showing a statistically significant improvement in spleen volume reduction. However, it did not achieve the second co-primary endpoint related to symptom improvement.
The trial enrolled 353 patients, randomized 2:1 to receive either 60 mg of selinexor weekly plus ruxolitinib or placebo plus ruxolitinib. At week 24, 50% of patients in the combination group achieved a 35% or greater reduction in spleen volume (SVR35), compared to 28% in the ruxolitinib-only group.
Although both treatment groups showed similar symptom improvements from baseline, the difference was not statistically significant. Patients receiving the combination therapy had an absolute total symptom score improvement of 9.89 points, while the ruxolitinib-only group improved by 10.86 points.
The trial also showed a promising overall survival signal, with a hazard ratio of 0.43 for the combination group compared to ruxolitinib alone. The company plans to continue monitoring overall survival data until maturity.
In exploratory endpoints, 32% of patients in the combination group experienced a reduction of 20% or more in variant allele frequency at week 24, compared to 24% in the ruxolitinib-only group, suggesting potential disease-modifying effects.
The combination therapy demonstrated a manageable safety profile, with no new safety signals. The most common adverse events in the combination group were thrombocytopenia (59%), anemia (57%), and nausea (57%).
Karyopharm plans to meet with the FDA to discuss these data and the potential submission of a supplemental New Drug Application. The company also announced a private placement with RA Capital Management, expected to raise approximately $30 million in total proceeds.
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