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Lilly presents first clinical data in platinum-sensitive ovarian cancer for its investigational, next-generation, FRα-targeting ADC at ESMO 2026

PR Newswire•24/10/2026•02:30 ET
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Key Highlights

  • ➤79.3% cORR and 100% DCR in 29 measurable PSOC patients
  • ➤Responses remained consistent across FRα expression levels and prior PARPi exposure
  • ➤Median DOR and PFS were not reached after 6.2 and 10.2 months
  • ➤Grade ≥3 neutropenia reached 42%; anemia reached 24%; 6% discontinued
  • ➤FRAmework-01 advances Sofe-M across three global Phase 3 ovarian-cancer trials

Expert Statements

Jacob Van Naarden, Executive Vice President and President of Lilly Oncology

“The standard of care for platinum-sensitive ovarian cancer has remained unchanged for a decade and demands new treatment options. Results for Sofe-M show a promising efficacy and tolerability profile across both platinum-resistant and platinum-sensitive ovarian cancer, regardless of FRα expression levels or prior treatment. These data give us confidence as we continue to study Sofe-M in our Phase 3 FRAmework-01 program to bring this potential new medicine to the women who need it.”

Chrisann Kyi, MD, Gynecologic Medical Oncologist & Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center

“The durable and robust responses we've seen in patients with platinum-sensitive ovarian cancer are important, particularly in a PARPi pretreated population, where the response rate seen with Sofe-M exceeds what has been reported in published platinum re-challenge studies. The observed safety profile and low discontinuation rates, combined with early efficacy results, support the continued investigation of Sofe-M as a potentially meaningful new option for patients.”

Lilly presents first clinical data in platinum-sensitive ovarian cancer for its investigational, next-generation, FRα-targeting ADC at ESMO 2026 PR Newswire

Sofetabart mipitecan (Sofe-M) in combination with bevacizumab demonstrated a 79% confirmed objective response rate and 100% disease control rate, with similar activity observed across FRα expression levels

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