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Karyopharm Presents Updated Exploratory Subgroup Analyses from SIENDO Study in Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer During 2024 ASCO Plenary Series: Rapid Abstract Updates
Karyopharm Therapeutics presented updated subgroup analyses from the SIENDO study at the 2024 ASCO Meeting, focusing on advanced or recurrent TP53 wild-type endometrial cancer. Key findings include a median progression-free survival (PFS) of 28.4 months for selinexor-treated patients versus 5.2 months for the placebo group. Additionally, a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis showed a mean of 26 months for selinexor compared to 15 months for placebo. No new safety signals were identified. The exploratory subgroup analysis highlighted promising efficacy signals, with ongoing Phase 3 trials expected to provide definitive results by mid-2025.
NEWTON, Mass., June 1, 2024 /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 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The data were presented in a special ASCO plenary series rapid abstract update session on June 1 at 12:30pm CT and simultaneously published in the Gynecologic Oncology Journal.
The primary analysis of the Phase 3 SIENDO study of selinexor maintenance therapy in advanced or recurrent endometrial cancer showed improvements in median 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 exploratory subgroup analysis, 113 patients with TP53 wild-type advanced/recurrent endometrial cancer were randomized to receive selinexor (n=77) vs placebo (n=36) as maintenance therapy after 1L platinum-based chemotherapy. As of the April 1, 2024 data cut-off date, and a median duration of follow-up of 36.9 months, selinexor-treated patients had a median PFS of 28.4 months compared to 5.2 months for patients receiving placebo. In selinexor-treated patients with TP53 wild-type/pMMR and TP53 wild-type/dMMR endometrial cancer, median PFS was 39.5 months and 13.1 months compared to 4.9 months and 3.7 months in those treated with placebo, respectively. Although immature, preliminary overall survival (OS) in the TP53 wild-type subgroup was promising with a hazard ratio of 0.65; median OS for selinexor has not been reached.
The updated analyses also highlighted findings from a quality-adjusted time without symptoms or toxicity analysis (Q-TWiST) used to assess quality and toxicity-adjusted PFS. The findings showed the restricted mean Q-TWiST for selinexor to be 26 months compared to 15 months for placebo, resulting in a difference of nearly 11 months.
The primary analysis of the Phase 3 SIENDO study of selinexor maintenance therapy in advanced or recurrent endometrial cancer showed improvements in median 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 exploratory subgroup analysis, 113 patients with TP53 wild-type advanced/recurrent endometrial cancer were randomized to receive selinexor (n=77) vs placebo (n=36) as maintenance therapy after 1L platinum-based chemotherapy. As of the April 1, 2024 data cut-off date, and a median duration of follow-up of 36.9 months, selinexor-treated patients had a median PFS of 28.4 months compared to 5.2 months for patients receiving placebo. In selinexor-treated patients with TP53 wild-type/pMMR and TP53 wild-type/dMMR endometrial cancer, median PFS was 39.5 months and 13.1 months compared to 4.9 months and 3.7 months in those treated with placebo, respectively. Although immature, preliminary overall survival (OS) in the TP53 wild-type subgroup was promising with a hazard ratio of 0.65; median OS for selinexor has not been reached.
The updated analyses also highlighted findings from a quality-adjusted time without symptoms or toxicity analysis (Q-TWiST) used to assess quality and toxicity-adjusted PFS. The findings showed the restricted mean Q-TWiST for selinexor to be 26 months compared to 15 months for placebo, resulting in a difference of nearly 11 months.
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