The antibody-drug conjugate mirvetuximab soravtansine demonstrated a favorable benefit-risk profile in a prespecified subset of patients with folate receptor alpha (FRα)–positive ovarian cancer, following a comprehensive analysis of the phase III FORWARD I trial, according to ImmunoGen, the manufacturer of the agent.1
The news follows the company’s March 2019 announcement that mirvetuximab soravtansine missed the study’s primary endpoint of progression-free survival (PFS) compared with chemotherapy in patients with FRα–positive, platinum-resistant ovarian cancer and in an overall patient population.2
Although PFS was longer with mirvetuximab soravtansine in the prespecified high FRα–positive subgroup (HR, 0.69; P = .049), it was not enough to reach statistical significance as per a prespecified statistical analysis plan.
In the overall study population, no significant difference in PFS was observed (HR, 0.98; P
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