Multinational phase 2 trial of third- or later-line mirvetuximab soravtansine for FRα-positive platinum-sensitive ovarian cancer

Mirvetuximab soravtansine-gynx (MIRV) is a folate receptor alpha (FRα)-targeting antibody-drug conjugate. The multinational phase 2 PICCOLO trial evaluated MIRV as third- or later-line treatment for FRα-positive (≥75% of cells with ≥2+ staining intensity) recurrent platinum-sensitive ovarian cancer (PSOC). Seventy-nine patients were enrolled and efficacy evaluable. The primary endpoint was met with an ORR of 51.9% (95% CI 40.4-63.3). The median duration of response was 8.25 months (95% CI 5.55-10.78), the median progression-free survival was 6.93 months (5.85-9.59), and the median overall survival was not mature at data cutoff. In patients with progressive disease while on or within 30 days after prior PARP inhibitor the ORR was 45.8% (95% CI 32.7-59.2). No new safety signals were observed. Treament-emergent adverse events led to discontinuation in 13 patients (16%) and death in two patients (3%). The authors conclude that MIRV as ≥3L treatment in heavily pretreated recurrent FRα-positive PSOC demonstrated notable efficacy and tolerable safety, including among those with prior progressive disease on or within 30 days of PARP inhibitor.