Genmab reports positive Phase 1/2 data for Rina-S in ovarian cancer

Genmab A/S has reported positive Phase 1/2 data for its investigational antibody-drug conjugate, rinatabart sesutecan (Rina-S), in treating patients with platinum-resistant ovarian cancer.

In the RAINFOL-01 trial (Part C cohort), 109 patients received Rina-S as a monotherapy at a dose of 120 mg/m² every three weeks. The study reported a confirmed objective response rate of 45.9%, which included five complete responses. The median duration of response was 12.1 months, and 51% of responders maintained their response after one year. The median progression-free survival was recorded at 9.5 months.

Researchers noted antitumor activity across various levels of folate receptor alpha (FRα) expression, including low and non-expressing patients. The study also observed responses in patients regardless of prior treatment with mirvetuximab soravtansine. Most participants had previously undergone multiple lines of therapy, including bevacizumab and taxane treatments.

Safety findings were generally consistent with the known profile of Rina-S. Common adverse events included fatigue, nausea, vomiting, and abdominal pain, while hematologic events included anemia and neutropenia. Serious adverse events occurred in approximately one-third of participants, and 5.5% of patients discontinued treatment due to adverse events.