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Angeles A. Secord, MD, MHSc, discusses the PICCOLO trial of mirvetuximab soravtansine in recurrent, platinum-sensitive, FRα-high ovarian cancer.
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Angeles A. Secord, MD, MHSc, professor, obstetrics and gynecology, Duke Cancer Institute, discusses findings from the phase 2 PICCOLO trial (NCT05041257) investigating mirvetuximab soravtansine-gynx (Elahere) in patients with recurrent, platinum-sensitive ovarian cancer with high folate receptor alpha (FRα) expression.
The single-arm, open-label trial evaluated mirvetuximab soravtansine at a dose of 6 mg/kg every 3 weeks in patients who had received at least 3 prior lines of therapy, including at least 2 platinum-containing regimens. Patients with BRCA-mutated disease were required to have received a prior PARP inhibitor, and prior exposure to bevacizumab (Avastin) was not required.
The trial’s primary end point of investigator-assessed overall response rate (ORR) in the overall population (n = 79) was 51.9% (95% CI, 40.4%-63.3%) and consisted of best overall responses of complete response (7.6%), partial response (44.3%), stable disease (36.7%), progressive disease (8.9%), and not evaluable (2.5%). The median duration of response (DOR), which was a key secondary end point, was 8.25 months (95% CI, 5.55-10.78). The median progression-free survival was 6.93 months (95% CI, 5.85-9.59).
Among patients with prior PARP inhibitor exposure (n = 64), the ORR was 46.9% (95% CI, 34.3%-59.8%), and the median DOR was 8.3 months (95% CI, 5.5-10.8). Among those who had progressed on prior PARP inhibitors (n = 59), the ORR was 45.8% (95% CI, 32.7%-59.2%), and the median DOR was 7.3 months (95% CI, 5.0-10.8). Among patients who were PARP inhibitor–naive (n = 12), the ORR was 75.0% (95% CI, 42.8%-94.5%), and the median DOR was 8.8 months (95% CI, 3.5-NR).
Testing patients for FRα expression level is crucial for clinical decision-making for patients with ovarian cancer, Secord says, as high FRα expression is a key biomarker of efficacy of several therapies for this disease. Knowing a patient’s FRα expression level also aids in determining optimal, personalized treatment sequencing, she concludes.
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