Eli Lilly Posts 79.3% Response Rate for Ovarian Cancer Drug

Eli Lilly and Company's investigational drug sofetabart mipitecan, known as Sofe-M, produced a 79.3% confirmed response rate with bevacizumab in Phase 1 testing of platinum-sensitive ovarian cancer, ahead of its Phase 3 program.

The response measure applied to 29 women with measurable disease, 23 of whom responded. Six had complete responses and 17 had partial responses. The full group included 33 women, who had received a median of three prior systemic treatment regimens, ranging from one to six. Prior PARP-inhibitor use was listed for 67% of participants, while 70% had previously received bevacizumab. The data cutoff was July 6, 2026.

The trial's disease-control rate was 100%, though its denominator was unspecified. The median duration of response remained unreached at a median follow-up of 6.2 months; median progression-free survival likewise had not been reached after 10.2 months.

Sofe-M is an investigational antibody-drug conjugate that targets folate receptor alpha and carries an exatecan payload. The combination cohort received 4 mg/kg of Sofe-M and 15 mg/kg of bevacizumab. Platinum-sensitive ovarian cancer describes disease that returns more than six months after platinum-based chemotherapy.

Nausea and nosebleeds each occurred in 73% of patients. Anemia occurred in 58%, neutropenia in 55% and fatigue in 52%. Grade 3 or higher neutropenia occurred in 42%, while anemia of the same severity occurred in 24%. Dose reductions were made for 42% of patients; 6% stopped treatment because of an adverse event.

FRAmework-01 has three parts: Sofe-M alone in platinum-resistant disease and two combination groups with platinum-sensitive disease, divided by prior PARP-inhibitor treatment. The Phase 3 program uses a 3 mg/kg Sofe-M dose selected from monotherapy safety, efficacy and pharmacokinetic data; the Phase 1 combination cohort used 4 mg/kg.

Eli Lilly shares closed at $1,273.46 on Oct. 23, down $33.23 from the previous close of $1,306.69, a 2.54% decline. The company's release carried a 2:30 a.m. ET timestamp on Oct. 24 (6:30 a.m. UTC), after Friday's close.

Chrisann Kyi, MD, a gynecologic medical oncologist and early drug development specialist at Memorial Sloan Kettering Cancer Center, said: “The durable and robust responses we've seen in patients with platinum-sensitive ovarian cancer are important.” The data were scheduled for presentation at the European Society for Medical Oncology congress on Oct. 24 at 2:30 a.m. ET (6:30 a.m. UTC).