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Karyopharm Announces Presentation of Updated Exploratory Subgroup Analyses from SIENDO Study in Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer
Signal of PFS Improvement in SIENDO for Selinexor-Treated Patients was Observed Only in Subgroup Who are TP53 Wild-Type with a Median Progression-Free
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"Signal of PFS Improvement in SIENDO for Selinexor-Treated Patients was Observed Only in Subgroup Who are TP53 Wild-Type with a Median Progression-Free Survival of 27.4 Months \nMedian PFS Not Reached for Selinexor-Treated Patients Who are TP53 Wild-Type MSS (pMMR) \nUpdated Analysis Provides Further Rationale for XPORT-EC-042, the Ongoing Pivotal Phase 3 Study (NCT05611931) Evaluating Selinexor as Maintenance Therapy in TP53 Wild-Type Endometrial Cancer\nNEWTON, Mass., July 25, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the presentation of updated exploratory subgroup analyses from the SIENDO study (NCT03555422) in patients with advanced or recurrent TP53 wild-type endometrial cancer at the virtual American Society of Clinical Oncology (ASCO) Plenary Series.\n\n \n \n \n \n \n \n\n \nCurrently, there are no specific targeted therapies available for patients with TP53 wild-type endometrial cancer. Advanced and recurrent endometrial cancer is associated with a poor prognosis, including limited disease control for patients who relapse after first-line systemic treatment.1 TP53 wild-type is found in approximately 50% of advanced/recurrent tumors in patients with endometrial cancer.2,3 TP53 wild-type is observed in both MSS (pMMR) and MSI-H (dMMR) populations. Recently there has been progress in potential treatment options in the MSI-H (dMMR) subgroup with new targeted treatments. However, a large unmet need continues to exist for MSS (pMMR), which comprises approximately 70% of all endometrial cancer patients and of that population, approximately 70% are TP53 wild-type.\nThe primary analysis of the Phase 3 SIENDO study of selinexor maintenance therapy in advanced or recurrent endometrial cancer showed improvements in median progression-free survival (PFS) for the intent-to-treat (ITT) population but were not clinically meaningful. However, an exploratory analysis of a pre-specified subgroup of patients with TP53 wild-type endometrial cancer showed a promising efficacy signal. In the SIENDO study, 263 patients were randomly assigned, with 174 patients allocated to the selinexor arm and 89 patients to the placebo arm. One hundred and thirteen patients with TP53 wild-type endometrial cancer were randomized to receive seli...