Genmab Reports Safety Data for Rina-S and Bevacizumab in Ovarian Cancer
Genmab announced new data demonstrating that rinatabart sesutecan, an investigational folate receptor alpha-targeted, topoisomerase I inhibitor antibody-drug conjugate, evaluated in combination with bevacizumab in patients with advanced ovarian cancer, showed a safety profile consistent with the known safety profiles of Rina-S and bevacizumab. These data are from the combination therapy cohort D2 of the multi-part Phase 1/2 RAINFOL-01 study and were presented during an oral session at the 2026 Society of Gynecologic Oncology Annual Meeting on Women's Cancer in San Juan, Puerto Rico. "Advanced ovarian cancer is a complex and difficult-to-treat disease, and the ability for investigational therapies such as Rina-S to be safely combined with bevacizumab can provide clinicians with more options to help improve disease control and manage resistance," said Cara Mathews, study investigator and Associate Professor, Obstetrics and Gynecology at the Women and Infants Hospital, Brown University. "Rina-S has shown a manageable safety profile as a monotherapy, and these safety data suggest that it may be combined with a standard-of-care therapy such as bevacizumab without significantly increasing the risk of additional side effects." As of data cutoff, 40 patients with recurrent ovarian cancer had received Rina-S plus bevacizumab every three weeks until disease progression or unacceptable toxicity. The primary endpoint was safety and tolerability. The combination of Rina-S and bevacizumab was tolerable, with manageable adverse events. The safety profile of the combination was consistent with the known safety profiles of the individual agents, with no new or unexpected safety signals. The most common treatment-emergent AEs included nausea, fatigue, anemia, and neutropenia. No safety signals of ocular toxicities, peripheral neuropathy or interstitial lung disease were reported, and no clinically significant bleeding was observed. Serious TEAEs occurred in six patients, and TEAEs leading to Rina-S dose reductions occurred in 11 patients. Rina-S and bevacizumab discontinuation occurred in two patients. No fatal TEAEs were reported.