Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
Carboplatin Plus Mirvetuximab Soravtansine In Platinum-Sensitive Ovarian Cancer: A Phase 2 Nonrandomized Clinical Trial.
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Konecny Gottfried E, Lim Peter C, Santin Alessandro D, Gilbert Lucy, Alvarez Secord Angeles, Bessette Paul, Matulonis Ursula A, Sen Jayita, Hong Jaehyung, Lytle Grace E, Bako Emarjola, Spunt Sheri L, Provencher Diane, Madariaga Ainhoa, Banerjee Susana, Eskander Ramez N, Perez-Fidalgo Jose Alejandro, Roque Dario, Oaknin Ana
Аннотация
PURPOSE: Evaluate efficacy and safety of carboplatin plus mirvetuximab soravtansine (MIRV) in folate receptor alpha (FRa)-expressing recurrent PSOC.
PATIENTS AND METHODS: This phase 2, single arm trial enrolled patients with recurrent FRa-expressing (≥25% of tumor cells with ≥2+ membrane intensity) PSOC and 1 prior platinum-based therapy. Patients received up to 6-8 cycles of carboplatin (AUC 5) plus MIRV (6mg/kg AIBW) Q3W, followed by single-agent MIRV. Primary and key secondary endpoints were investigator-assessed objective response rate (ORR) per RECIST v1.1 in the FRa ≥50% group and FRa ≥25% group (ie, overall population), respectively.
RESULTS: Among 125 enrolled patients (102 FRα ≥50%; 61 prior PARPi), ORR by end of 6 combination cycles was 62.7% (95% CI, 52.6-72.1) in the FRα ≥50% group and 62.4% (95% CI, 53.3-70.9) in the overall population. Most patients (n=101; 81%) transitioned to single-agent MIRV continuation with durable responses. Patients with FRa ≥25% had median duration of response of 11.2 months (95% CI, 8.5-13.6) and median progression-free survival of 11.0 months (95% CI, 9.8-13.1). Most common adverse events (AEs) were blurred vision (81%) and corneal events (74%); 96.7% of corneal cases resolved or had final grade 1. Treatment-emergent AEs led to MIRV and carboplatin discontinuation in 15% and 9%, respectively. Adjudicated treatment-related pneumonitis occurred in 19 (15.2%) patients: 14 grade 1-2; 3 grade 3-4, and 2 fatal cases.
CONCLUSIONS: Carboplatin plus MIRV was manageable with dose modifications for AEs and showed meaningful activity, including in PARPi-exposed patients, supporting further evaluation in PSOC.
PATIENTS AND METHODS: This phase 2, single arm trial enrolled patients with recurrent FRa-expressing (≥25% of tumor cells with ≥2+ membrane intensity) PSOC and 1 prior platinum-based therapy. Patients received up to 6-8 cycles of carboplatin (AUC 5) plus MIRV (6mg/kg AIBW) Q3W, followed by single-agent MIRV. Primary and key secondary endpoints were investigator-assessed objective response rate (ORR) per RECIST v1.1 in the FRa ≥50% group and FRa ≥25% group (ie, overall population), respectively.
RESULTS: Among 125 enrolled patients (102 FRα ≥50%; 61 prior PARPi), ORR by end of 6 combination cycles was 62.7% (95% CI, 52.6-72.1) in the FRα ≥50% group and 62.4% (95% CI, 53.3-70.9) in the overall population. Most patients (n=101; 81%) transitioned to single-agent MIRV continuation with durable responses. Patients with FRa ≥25% had median duration of response of 11.2 months (95% CI, 8.5-13.6) and median progression-free survival of 11.0 months (95% CI, 9.8-13.1). Most common adverse events (AEs) were blurred vision (81%) and corneal events (74%); 96.7% of corneal cases resolved or had final grade 1. Treatment-emergent AEs led to MIRV and carboplatin discontinuation in 15% and 9%, respectively. Adjudicated treatment-related pneumonitis occurred in 19 (15.2%) patients: 14 grade 1-2; 3 grade 3-4, and 2 fatal cases.
CONCLUSIONS: Carboplatin plus MIRV was manageable with dose modifications for AEs and showed meaningful activity, including in PARPi-exposed patients, supporting further evaluation in PSOC.