Denmark-based biotechnology company Genmab A/S (Nasdaq: GMAB) reported on Monday that its Phase 1/2 RAINFOL-01 data showed that rinatabart sesutecan (Rina-S) in combination with bevacizumab demonstrated a tolerable safety profile in patients with advanced ovarian cancer, with no new safety signals identified.
Findings from the RAINFOL-01 study were presented at the 2026 Society of Gynecologic Oncology Annual Meeting. The combination therapy cohort included 40 patients with recurrent ovarian cancer receiving Rina-S alongside bevacizumab every three weeks until disease progression or unacceptable toxicity.
The primary endpoint of safety and tolerability was met, with adverse events considered manageable and consistent with the known profiles of both agents. The most common treatment-emergent adverse events included nausea, fatigue, anaemia and neutropenia. Serious adverse events were reported in 15% of patients, while dose reductions occurred in 27.5%. Treatment discontinuation was limited to 5% of patients, and no fatal adverse events were recorded.
Genmab is advancing Rina-S through a broad late-stage clinical programme, including multiple Phase 3 trials across ovarian, endometrial and other cancers. The ongoing Phase 3 RAINFOL-04 study is evaluating the combination therapy as a maintenance treatment in patients with recurrent platinum-sensitive ovarian cancer.
The company said the data support continued development of Rina-S as part of combination strategies targeting cancers expressing folate receptor alpha, addressing significant unmet medical need in ovarian cancer treatment.
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