Eli Lilly's Next-Generation Ovarian Cancer Drug Shows 79% Response Rate, 100% Disease Control In New Data

• Sofe-M is an investigational folate receptor alpha-targeting antibody-drug conjugate, which was evaluated by Lilly with bevacizumab in 33 women with platinum-sensitive ovarian cancer.
• Among the 29 patients with measurable disease, Lilly stated that the confirmed objective response rate was 79.3%, with 23 patients responding, adding that the disease control rate was 100%.
• Sofe-M is designed to target FRα on tumor cells and deliver exatecan, a topoisomerase I inhibitor, directly into the cancer cell.

Eli Lilly & Co. (LLY) on Saturday announced new clinical data for its investigational ovarian cancer drug sofetabart mipitecan, or Sofe-M, at the European Society for Medical Oncology (ESMO) 2026 Congress in Madrid.

The results come as Lilly continues to test Sofe-M in different types of ovarian cancer, with multiple Phase 3 trials now underway.

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Eli Lilly shares closed nearly 3% lower in Friday’s regular trade, but inched up 0.4% during the afterhours session.

Lilly's Ovarian Cancer Drug Shows 79% Response Rate

Sofe-M is an investigational folate receptor alpha (FRα)-targeting antibody-drug conjugate. Lilly evaluated the drug with bevacizumab in 33 women with platinum-sensitive ovarian cancer.

Among the 29 patients with measurable disease, Lilly stated that the confirmed objective response rate was 79.3%, with 23 patients responding, adding that the disease control rate was 100%.

Lilly said responses were consistent across FRα expression levels and regardless of prior poly (ADP-ribose) polymerase (PARP) inhibitor exposure. That is notable given that 67% of patients had previously received a PARP inhibitor and 70% had received bevacizumab.

Patients had received a median of three prior systemic treatment regimens. Median duration of response and median progression-free survival had not been reached at the July 6, 2026 data cutoff, with median follow-ups of 6.2 months and 10.2 months, respectively.

“The durable and robust responses we've seen in patients with platinum-sensitive ovarian cancer are important,” said Chrisann Kyi, MD, a gynecologic medical oncologist and early drug development specialist at Memorial Sloan Kettering Cancer Center.

Kyi said the response rate with Sofe-M exceeded what has been reported in published platinum rechallenge studies for patients previously treated with PARP inhibitors.

Lilly Advances Sofe-M Into Phase 3

Sofe-M is designed to target FRα on tumor cells and deliver exatecan, a topoisomerase I inhibitor, directly into the cancer cell. Lilly says the drug is designed to target tumors across a broad range of FRα expression levels.

The company is now evaluating Sofe-M in the three-part Phase 3 FRAmework-01 program.

Part A is testing Sofe-M as a monotherapy in platinum-resistant ovarian cancer. Part B is evaluating Sofe-M plus bevacizumab in platinum-sensitive disease that progressed on or within six months of completing PARP inhibitor treatment. Part C is testing the combination in PARP inhibitor-naïve platinum-sensitive disease.

The Phase 1 safety profile was consistent with the known profiles of the medicines, with no new safety signals reported. The most common treatment-emergent adverse events included epistaxis, nausea, anemia, neutropenia and fatigue.

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LLY stock is up 19% year-to-date and 55% over the past 12 months. The S&P 500 ETF (SPY) is up 11% over the past 12 months, while the Vanguard Morningstar Growth ETF (VUG) is up 7%.

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