Pull to refresh
Logo
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

Today: Lilly presents Sofe-M Phase 1 data at ESMO 2026

Overview

Updated 1 hour ago

Eli Lilly presented first clinical data at ESMO 2026 for sofetabart mipitecan (Sofe-M), its experimental folate receptor alpha (FRα)-targeting antibody-drug conjugate. Combined with bevacizumab, the drug shrank tumors in 79% of platinum-sensitive ovarian cancer patients, with all 29 evaluable patients achieving disease control.

Responses were consistent across FRα expression levels and in patients with prior PARP inhibitor exposure, a group that typically responds poorly to platinum re-treatment. Three Phase 3 trials under the FRAmework-01 master protocol will test whether the benefit holds in a larger population.

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.

Questions about this story

Free account needed to ask — your question is kept and asked for you right after sign-up. Answers are public.

No questions yet — be the first to ask.

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
42%
Grade 3 or higher neutropenia
Most common severe side effect; febrile neutropenia occurred in 3% of patients

Voices

Curated perspectives — historical figures and your fellow readers.

Ever wondered what historical figures would say about today's headlines?

Sign up to generate historical perspectives on this story.

People Involved

Organizations Involved

Timeline

2022 October 2026

6 events Latest: Today
Tap a bar to jump to that date
  1. Lilly presents Sofe-M Phase 1 data at ESMO 2026

    Today 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. Lilly launches Phase 3 FRAmework-01 trial

    Trial launch

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

  6. 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

(4)