Eli Lilly reports 79% response and 100% disease‑control in Phase 1 ovarian‑cancer ADC trial

Eli Lilly presented Phase 1 results for its folate‑receptor‑alpha‑targeting antibody‑drug conjugate sofetabart mipitecan (Sofe‑M) combined with bevacizumab in platinum‑sensitive ovarian cancer. The 33‑patient cohort achieved a confirmed objective response rate of 79% (79.3% among measurable disease) and a disease‑control rate of 100%, with activity across FRα expression levels and prior PARP‑inhibitor exposure. The regimen was dosed at 4 mg/kg Sofe‑M plus 15 mg/kg bevacizumab, and safety was consistent with known profiles, with the most common any‑grade adverse events being epistaxis (73%) and nausea (73%).

The company says the data support continued advancement of Sofe‑M in its three‑part FRAmework‑01 Phase 3 program, potentially expanding Lilly’s oncology pipeline and future revenue streams. Seeking Alpha notes the announcement helped lift LLY shares, indicating market enthusiasm for the early‑stage results.

  • 1The Phase 1 study enrolled 33 women with platinum‑sensitive ovarian cancer.
  • 2Confirmed objective response rate (cORR) was 79% overall and 79.3% (23/29) among patients with measurable disease.
  • 3Disease‑control rate (DCR) was 100%.
  • 4Patients received Sofe‑M at 4 mg/kg plus bevacizumab at 15 mg/kg.
  • 5Median number of prior systemic regimens was three (range 1–6).
  • 6Median follow‑up was 6.2 months for duration of response and 10.2 months for progression‑free survival (both not reached).

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