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Karyopharm Announces Phase 3 SEAL Study Meets Primary Endpoint with Significant Increase in Progression-Free Survival in Patients with Unresectable Dedifferentiated Liposarcoma
-- Twice-Weekly XPOVIO® (selinexor) Demonstrates a Statistically Significant Reduction in the Risk of Disease Progression or Death Compared to Placebo; Hazard
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"-- Twice-Weekly XPOVIO® (selinexor) Demonstrates a Statistically Significant Reduction in the Risk of Disease Progression or Death Compared to Placebo; Hazard Ratio of 0.70, p=0.023 --\n -- Positive Pivotal Data in Liposarcoma Demonstrates Substantial Potential Across Multiple Solid Tumors, Representing a Major Advance for the Development and Commercial Potential of XPOVIO in Oncology --\n -- Full Data to be Presented Virtually in an Oral Presentation at the Connective Tissue Oncology Society (CTOS) Annual Meeting on November 20th --\n -- Management to Host Conference Call to Review the Detailed Clinical Data on November 20th at 12:00 PM ET --\n\n\n NEWTON, Mass., Nov. 2, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced positive top-line results from the Phase 3 portion of the randomized, double blind, placebo controlled, cross-over, SEAL study evaluating single agent, oral XPOVIO® (selinexor) versus matching placebo in patients with advanced unresectable dedifferentiated liposarcoma. The SEAL study met its primary endpoint of a statistically significant increase in progression-free survival (PFS); hazard ratio=0.70; p=0.023. These data indicate that treatment with XPOVIO reduced the risk of disease progression or death by approximately 30%, compared to placebo. The trial allowed patients on placebo with objective progression to cross over to the XPOVIO treatment arm. Among those patients who received XPOVIO, there was a trend towards an improvement in the median overall survival compared to those patients who began on the placebo arm of the study and never crossed over to the XPOVIO treatment arm. The safety profile for XPOVIO was consistent with previous clinical studies with fewer hematologic and infectious adverse events as compared to XPOVIO studies in patients with multiple myeloma and diffuse large B-cell lymphoma (DLBCL).\nThe detailed results from the SEAL study will be presented virtually in an oral presentation at the Connective Tissue Oncology Society (CTOS) Annual Meeting on Friday, November 20, 2020 at 10:30 AM ET.\n\"We are delighted to share these significant top-line results from the Phase 3 portion of the SEAL study, the first, late-stage clinical data for XPOVIO in a solid tumor indication,\" said Shar...