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Lilly's ovarian cancer ADC posts 79% response rate in platinum-sensitive disease

Lilly's ovarian cancer ADC posts 79% response rate in platinum-sensitive disease

New Capabilities

Sofe-M plus bevacizumab hit 100% disease control in Phase 1, with consistent responses across FRα expression levels and prior PARP inhibitor exposure

October 24th, 2026: Lilly presents Sofe-M Phase 1 data at ESMO 2026

Overview

Updated Oct 26

Sofetabart mipitecan (Sofe-M) plus bevacizumab shrank tumors in 23 of 29 evaluable platinum-sensitive ovarian cancer patients, a 79.3% confirmed response rate. Every patient in the Phase 1 cohort had a response or stable disease, and the rate held in patients who had already taken a PARP inhibitor.

Lilly is enrolling an estimated 1,630 patients across three Phase 3 trials in the FRAmework-01 program, which measure progression-free survival. The FDA granted Sofe-M breakthrough therapy designation in January 2026 for platinum-resistant disease in patients already treated with bevacizumab and mirvetuximab.

Why it matters

Platinum-sensitive ovarian cancer relapse care has not changed in a decade; a targeted therapy that works after PARP inhibitors could become the new standard.

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Key Indicators

79.3%
Confirmed objective response rate
23 of 29 evaluable platinum-sensitive ovarian cancer patients showed tumor shrinkage
100%
Disease control rate
All 29 evaluable patients had a response or stable disease
33
Patients in Phase 1 PSOC cohort
Received Sofe-M 4 mg/kg plus bevacizumab 15 mg/kg; median of 3 prior regimens
50.5%
Response rate as monotherapy
Confirmed responses in 105 heavily pretreated high-grade ovarian cancer patients in the dose-finding study, 98% of them platinum-resistant
42%
Grade 3 or higher neutropenia
Most common severe side effect; febrile neutropenia occurred in 3% of patients

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People Involved

JN
Jacob Van Naarden
President, Lilly Oncology
Leading Lilly's oncology division during Sofe-M development

Organizations Involved

Eli Lilly and Company
Eli Lilly and Company
Pharmaceutical company
Developer of sofetabart mipitecan (Sofe-M)

Indianapolis-based drugmaker developing Sofe-M, an FRα-targeting antibody-drug conjugate with a topoisomerase I inhibitor payload.
AbbVie (Allergan)
AbbVie (Allergan)
Pharmaceutical company
Competitor with Elahere (mirvetuximab soravtansine)

Markets Elahere, the first FDA-approved FRα-directed antibody-drug conjugate, and is testing it in a Phase 3 platinum-sensitive ovarian cancer trial.
Genmab
Genmab
Biopharmaceutical company
Competitor with rinatabart sesutecan

Running a Phase 3 trial of its FRα-directed ADC rinatabart sesutecan in platinum-sensitive ovarian cancer, begun in April 2026.
AstraZeneca
AstraZeneca
Pharmaceutical company
Competitor with torvutatug samrotecan

Started a Phase 3 trial of its FRα-directed ADC torvutatug samrotecan in platinum-sensitive ovarian cancer in September 2026.

Timeline

2022 October 2026

7 events Latest: October 24th, 2026 · 3 weeks ago
Tap a bar to jump to that date

  1. Lilly presents Sofe-M Phase 1 data at ESMO 2026

    Latest Data presentation

    79.3% confirmed response rate and 100% disease control in platinum-sensitive ovarian cancer patients.

  2. AstraZeneca starts Phase 3 FRα ADC trial

    Competitive

    Torvutatug samrotecan enters Phase 3 in platinum-sensitive ovarian cancer.

  3. Phase 1 PSOC data cutoff

    Data

    Final analysis for the platinum-sensitive ovarian cancer cohort of the Sofe-M Phase 1 trial.

  4. Genmab begins Phase 3 PSOC trial

    Competitive

    Rinatabart sesutecan, Genmab's FRα-directed ADC, enters Phase 3 in platinum-sensitive ovarian cancer.

  5. FDA grants breakthrough therapy designation for Sofe-M

    Regulatory

    Designation covers platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer in patients who received bevacizumab and, if eligible, mirvetuximab.

  6. Lilly launches Phase 3 FRAmework-01 trial

    Trial launch

    Three-part master protocol testing Sofe-M across platinum-sensitive and platinum-resistant ovarian cancer.

  7. FDA approves AbbVie's Elahere for platinum-resistant ovarian cancer

    Regulatory

    First FRα-directed antibody-drug conjugate approved, for patients with high FRα expression.

Scenarios

1

Sofe-M wins FDA approval in platinum-sensitive ovarian cancer

Possible Resolves by End of 2030

Discussed by: Lilly executives cited the Phase 1 results as confidence for the FRAmework-01 program. Fierce Biotech noted Lilly is enrolling broader populations than AbbVie.

The FRAmework-01 Phase 3 trials complete enrollment and show a progression-free survival benefit for Sofe-M plus bevacizumab versus standard platinum-based doublet chemotherapy. Lilly files for approval and the FDA grants it for platinum-sensitive ovarian cancer.

2

FRAmework-01 misses its primary endpoint

Possible Resolves by End of 2029

Discussed by: Phase 3 oncology trials routinely fail to confirm Phase 1 signals. The competitive pressure from three other FRα ADCs in development adds execution risk.

One or more parts of FRAmework-01 fail to show a statistically significant improvement in progression-free survival. Lilly either narrows the development plan or abandons the indication, leaving the Phase 1 response rate as the high point.

3

A rival FRα ADC reaches the platinum-sensitive market first

Uncertain Resolves by End of 2030

Discussed by: Fierce Biotech reported Genmab has a clearer lead in platinum-resistant disease while the platinum-sensitive race is close. TOPO-1 payload resistance may limit sequential use of rival ADCs, making first-to-market valuable.

AbbVie's Elahere expansion, Genmab's rinatabart sesutecan, or AstraZeneca's torvutatug samrotecan receives FDA approval for platinum-sensitive ovarian cancer before Sofe-M. The first approved FRα ADC in this setting establishes treatment precedence, and TOPO-1 payload resistance could make it the only option patients receive.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

November 2022

Mirvetuximab soravtansine (Elahere) FDA approval (2022)

AbbVie's Elahere became the first FRα-directed antibody-drug conjugate approved by the FDA, for platinum-resistant ovarian cancer patients with high FRα expression. The approval was based on the SORAYA trial in heavily pre-treated patients.

Then

Gave a targeted option to patients who had exhausted chemotherapy alternatives.

Now

Validated FRα as a druggable target while leaving patients with lower FRα expression without a matching therapy.

Why this matters now

Sofe-M is designed to work regardless of FRα expression levels, directly addressing the patient-selection limitation that constrained Elahere's reach.

2014-2020

PARP inhibitor expansion in ovarian cancer (2014-2020)

Olaparib (Lynparza) moved from treating late-stage BRCA-mutated ovarian cancer to first-line maintenance therapy, extending progression-free survival and making biomarker testing standard.

Then

Extended remission durations for many patients after initial platinum-based chemotherapy.

Now

Created a growing population of patients who eventually develop PARP inhibitor resistance and need new treatment options.

Why this matters now

Two-thirds of Sofe-M's Phase 1 cohort had prior PARP inhibitor exposure, and responses were consistent in PARPi-treated and PARPi-naïve patients, addressing the resistance problem the PARP class created.

Sources

(5)
PR Newswire Eli Lilly and Company Investor Relations Fierce Biotech StockTitan Targeted Oncology