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Phase II PICCOLO Trial: Mirvetuximab Soravtansine-gynx in FRα-Positive, Platinum-Sensitive Ovarian Cancer

By: Jenna Carter, PhD
Posted: Monday, February 3, 2025

An article published in the Annals of Oncology highlighted the safety and efficacy of the FRα-targeting antibody-drug conjugate mirvetuximab soravantansine-gynx in treating FRα-positive recurrent, platinum-sensitive ovarian cancer in the third-line setting or later. A. Alvarez Secord, MD, of Duke University Medical Center, Durham, North Carolina, and colleagues examined data from the single-arm phase II PICCOLO trial. They reported an objective response rate of 51.9%, a median duration of response of 8.3 months, and a median progression-free survival of 6.9 months.

“Given the decreasing efficacy of chemotherapy and cumulative toxicities that occur with each successive recurrence, there is a need for additional treatment options for patients with [platinum-sensitive ovarian cancer] receiving second-line treatment and beyond,” stated Dr. Secord and colleagues.

A total of 79 patients were included in this study. Participants received mirvetuximab soravtansine intravenously (6 mg/kg, adjusted for ideal body weight every 3 weeks) until unacceptable toxicity, progressive disease, withdrawal of consent, or death. The primary endpoint was an investigator-assessed objective response rate, which was defined as the percentage of participants with a confirmed complete or partial response. The secondary endpoints included investigator-assessed duration of response, progression-free survival, and overall survival.

Findings revealed the overall response rate was 51.9% (95% confidence interval [CI] = 40.4%–63.3%), the median duration of response was 8.3 months (95% CI = 5.6–10.8 months), and the median progression-free survival was 6.9 months (95% CI = 5.9–9.6 months). Additionally, the objective response rate was 45.8% (95% CI = 32.7%–59.2%) in participants with progressive disease while on or within 30 days of prior PARP inhibitor treatment and 60.0% (95% CI = 14.7%–94.7%) in those without progressive disease who had prior PARP inhibitor treatment. Furthermore, the safety analyses revealed no new safety signals.

Disclosure: For full disclosures of the study authors, visit annalsofoncology.org.


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