Karyopharm Therapeutics Inc. · NASDAQ:KPTI
Karyopharm Therapeutics — Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer 2025
16 slides from Karyopharm Therapeutics's conference presentation, 2025
Slide 1: Multiply Your Impact – SGO Annual Meeting on Women's Cancer 2025
MULTIPLY YOUR IMPACT ANNUAL MEETING ON WOMEN’S CANCER SEATTLE, WA - 2025
Slide 2: Long-term safety and efficacy of selinexor maintenance treatment in TP53 wild-type endometrial cancer
Long-term safety and efficacy of selinexor maintenance treatment in patients with TP53 wild-type advanced or recurrent endometrial cancer: follow-up subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study Debra L. Richardson1, Vicky Makker2,3, Lydia Gaba4, Giorgio Valabrega5, Erika P Hamilton6, Too
Slide 3: Disclosures
Disclosures Debra L Richardson received speaking fees from Zentalis; Advisory Board fees from Genmab, Immuogen/Abbvie, Incyclix, Repare, GSK, Eisai and Daiichi Sankyo; and serves on the Board of Directors for Society of Gynecologic Oncology (SGO). Presented by Debra L. Richardson, MD, FACOG, FACS |
Slide 4: Selinexor is an Investigational Oral Maintenance Agent Targeting TP53wt Endometrial Cancer
Selinexor is an Investigational Oral Maintenance Agent Targeting TP53wt Endometrial Cancer • Immune checkpoint inhibitors showed clinically meaningful benefit in patients with dMMR EC, but benefit in those with pMMR tumors was more modest6-11 • TP53 is a well-recognized prognostic marker for EC; >50
Slide 5: ENGOT-EN5/GOG-3055/SIENDO (NCT03555422) trial design
ENGOT-EN5/GOG-3055/SIENDO (NCT03555422): A Randomized, Double-Blind, Phase 3 Trial of Maintenance With Selinexor/Placebo After Combination Chemotherapy for Patients With Advanced or Recurrent Endometrial Cancer Primary endpoint2 • PFS, per RECIST v1.1 Secondary endpoints2 • PFS by BICR, per RECIST v
Slide 6: Patient Demographics and Baseline Characteristics of the TP53wt Subgroup
Patient Demographics and Baseline Characteristics of the TP53wt Subgroup TP53wt* TP53wt* Selinexor Placebo Selinexor Placebo Characteristics n=77 n=36 Characteristic n=77 n=36 Age, years, median (range) 64.0 (40-81) 61.5 (33-74) Disease at time of taxane-platinum combination therapy, n (%) ≥70 years
Slide 7: Long-term Median PFS of 28.4 Months Was Observed
Long-term Median PFS of 28.4 Months Was Observed in the TP53wt Subgroup 1.00 Selinexor (n=77): 28.4 months (95% CI: 13.1, NR) Placebo (n=36): 5.2 months (95% CI: 2.0, 13.1) HR: 0.44 (95% CI: 0.27, 0.73); one-sided nominal P-value = 0.0005 0.75 Probability of PFS 0.50 0.25 36.8 months of follow-up 0.
Slide 8: PFS Improvements Were Observed Regardless of MMR Status
PFS Improvements Were Observed in the TP53wt Subgroup Regardless of MMR Status TP53wt/pMMR TP53wt/dMMR Selinexor (n=47): 39.5 months (95% CI: 19.3, NR) Selinexor (n=20): 13.1 months (95% CI: 3.6, NR) Placebo (n=23): 4.9 months (95% CI: 2.0, NR) Placebo (n=9): 3.7 months (95% CI: 1.9, NR) HR: 0.36 (9
Slide 9: Median Time to First Subsequent Therapy (TFST) of 31.7 Months Was Observed
Median Time to First Subsequent Therapy (TFST) of 31.7 Months Was Observed in the TP53wt Subgroup 1.00 Selinexor (n=77): 31.7 months (95% CI: 18.7, NR) • 50% of patients discontinued Placebo (n=36): 10.6 months (95% CI: 4.8, 15.1) HR: 0.41 (95% CI: 0.25, 0.68); one-sided nominal P-value = 0.0002 sel
Slide 10: Median Time to Second Disease Progression (PFS2) Was Not Reached
Median Time to Second Disease Progression (PFS2) Was Not Reached in the TP53wt Subgroup 1.00 Selinexor (n=77): NR (95% CI: 41.1, NR) Placebo (n=36): 35.2 months (95% CI: 17.3, NR) PFS2 (Time to Second HR: 0.62 (95% CI: 0.33, 1.36); one-sided nominal P-value = 0.0581 Progression or Death) 0.75 0.50 0
Slide 11: Median Time to Second Subsequent Therapy (TSST) Was Not Reached
Median Time to Second Subsequent Therapy (TSST) Was Not Reached in the TP53wt Subgroup 1.00 Selinexor (n=77): NR (95% CI: 43.9, NR) Placebo (n=36): 22.1 months (95% CI: 13.1, NR) HR: 0.47 (95% CI: 0.26, 0.83); one-sided nominal P-value = 0.0041 TSST (Time to Second Subsequent Therapy) 0.75 0.50 0.25
Slide 12: Improvements in Preliminary Overall Survival Were Observed
Improvements in Preliminary Overall Survival Were Observed in the TP53wt Subgroup Nominal No. with Median, months Overall HR one-sided Median follow- events (95% CI) maturity (95% CI) P-value up (months) TP53wt Selinexor (n=77) 24.7% NR (45.4, NR) 0.65 29.2% 0.11 36.8 (0.32, 1.29) Placebo (n=36) 38.
Slide 13: Treatment-emergent Adverse Events were Generally Low-Grade and Manageable
Treatment-emergent Adverse Events were Generally Low-Grade and Manageable Selinexor (n=76*) Placebo (n=35*) Nausea 90% 13% 40% Vomiting 60% 3% 3% 14% Diarrhea 45% 4% 37% Constipation 33% 6% 40% Asthenia 36% 5% 26% Fatigue 36% 8% 20% Thrombocytopenia 42% 10% 3% Decreased appetite 36% 3% Neutropenia 3
Slide 14: Improvements in Intermediate Endpoints Supporting a Potential Long-Term PFS Benefit
Improvements in Intermediate Endpoints were Observed With Selinexor Supporting a Potential Long-Term PFS Benefit in TP53wt EC • A strong PFS signal was observed with selinexor maintenance therapy in TP53wt advanced/recurrent EC regardless of MMR status • Consistent improvements in TFST, PFS2, and TS
Slide 15: ENGOT-EN20/GOG-3083/XPORT-EC-042 (NCT05611931)
ENGOT-EN20/GOG-3083/XPORT-EC-042 (NCT05611931) A Phase 3, Randomized, Placebo-controlled, Double-blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-type, Advanced or Recurrent Endometrial Carcinoma (NCT05611931)1,2 Study is ongoing and acti
Slide 16: Acknowledgments
Acknowledgments We thank participating patients and their families, all investigators, and academic study groups for participating in the SIENDO trial BGOG GOG GEICO CEEGOG MITO ISGO NOGGO USOC HeCOG China Canada USA Vergote Randall Perez-Fidalgo Cibula Valabrega Helpman Sehouli Tibayan Fountzilas Z