Eli Lilly reports 79% response rate for investigational ovarian cancer ADC in Phase 1 data

Eli Lilly presented Phase 1 results for its folate‑receptor‑alpha‑targeting antibody‑drug conjugate sofetabart mipitecan (Sofe‑M) combined with bevacizumab in 33 women with platinum‑sensitive ovarian cancer. The study showed a confirmed objective response rate of about 79 % and a disease‑control rate of 100 %, with activity across prior PARP‑inhibitor exposure. Patients received Sofe‑M at 4 mg/kg and bevacizumab at 15 mg/kg after a median of three prior regimens. The safety profile was consistent with known drug profiles and no new signals emerged.

Lilly says the data give confidence to continue advancing Sofe‑M in its FRAmework‑01 Phase 3 program, potentially expanding its oncology pipeline and supporting future revenue growth (source:).

  • 1The Phase 1 study enrolled a cohort of 33 women with platinum‑sensitive ovarian cancer.
  • 2Sofetabart mipitecan (Sofe‑M) was dosed at 4 mg/kg together with bevacizumab 15 mg/kg.
  • 3The confirmed objective response rate was 79 % and a more precise estimate of 79.3 % (23/29 patients) was reported.
  • 4Disease control rate was 100 %.
  • 5Patients had received a median of three prior systemic regimens (range 1–6).
  • 6Treatment‑emergent adverse events occurred in 73 % of patients for epistaxis and nausea, and 6 % discontinued due to adverse events.

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