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Karyopharm Announces Presentation of Updated Phase 1 Selinexor Data in Patients with Treatment-Naïve Myelofibrosis at AACR 2023
– At Week 24, 60mg of Selinexor in Combination with Ruxolitinib Achieved: 92% SVR35 and 78% TSS50 in Efficacy Evaluable Population, 79% SVR35 and 58% TSS50 in
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"– At Week 24, 60mg of Selinexor in Combination with Ruxolitinib Achieved: 92% SVR35 and 78% TSS50 in Efficacy Evaluable Population, 79% SVR35 and 58% TSS50 in Intent to Treat Population –\n– Rapid, Deep, Sustained Spleen Response Across all Subgroups, Robust Symptom Improvement with a Generally Tolerable and Manageable Side Effect Profile; 60mg Selinexor is the Recommended Dose in Combination with Ruxolitinib –\n– Planning to Initiate Pivotal Phase 3 Study in Front-Line Myelofibrosis in 1H 2023 –\n– Company to Host Investor Webcast with Key Opinion Leader Dr. John Mascarenhas, Professor of Medicine at the Icahn School of Medicine at Mount Sinai, Today at 4:30 p.m. ET –\nNEWTON, Mass., April 18, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced updated results from the Phase 1 study evaluating the safety and efficacy of once-weekly selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis (NCT04562389). The data, featured in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, show that rapid, deep and sustained spleen responses and robust symptom improvement were achieved at both weeks 12 and 24, in patients treated with selinexor 60mg in combination with ruxolitinib.\n\n \n \n \n \n \n \n\n \nAs of the February 24, 2023 data cut-off date, 24 patients had been assigned to either a 40mg or 60mg once weekly dose of selinexor, combined with ruxolitinib. All patients initiated treatment > 24 weeks prior to the data cut-off date.\nKey Findings\nEfficacySVR35 (≥35% reduction in spleen volume) and TSS50 (≥50% reduction in total symptom score)\n60mg of selinexor Week 12Efficacy evaluable population: 83.3% SVR35 and 80.0% TSS50Intent to treat population: 71.4% SVR35 and 66.7% TSS50Week 24Efficacy evaluable population: 91.7% SVR35 and 77.8% TSS50Intent to treat population: 78.6% SVR35 and 58.3% TSS50SVR35 responses were observed in 100% of evaluable patients at any time and rates were consistent regardless of subgroups, including males and patients treated with low dose ruxolitinib.Improvement in major spleen and cytokine-related symptoms were observed across all MFSAF (Myelofibrosis Symptom Assessment Form) domains.40mg of selinexor Week 12Efficacy evaluab...