Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers

Summary

PICCOLO (IMGN853-0419) is a Phase 2 multicenter, open label study designed to evaluate the safety and efficacy of Mirvetuximab Soravtansine in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.

Timeline

Start

2021-10-19

Primary completion

2024-12-12

Completion

2024-12-12

Outcome

Met primary endpoint

paper The primary endpoint was met; ORR was 51.9% [95% confidence interval (CI) 40.4% to 63.3%]. PMID 39617145 ↗

release “PICCOLO trial met its primary endpoint of objective response rate (ORR)” abbvie.com ↗

Publications

• Alvarez Secord A, Lewin SN, Murphy CG, Cecere SC, Barquin A, Galvez-Montosa F, Mathews CA, Konecny GE, Ray-Coquard I, Oaknin A, Rubio Perez MJ, Bonaventura A, Diver EJ, Ayuk SM, Wang Y, Corr BR, Salutari V. The efficacy and safety of mirvetuximab soravtansine in FRalpha-positive, third-line and later, recurrent platinum-sensitive ovarian cancer: the single-arm phase II PICCOLO trial. Ann Oncol. 2025 Mar;36(3):321-330. doi: 10.1016/j.annonc.2024.11.011. Epub 2024 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirvetuximab Soravtansine	Other / unclassified	6 mg/kg	Intravenous

Indications