Genmab’s Rina-S Shows Strong Response in Advanced Ovarian Cancer

Genmab A/S has announced updated results from its Phase 1/2 RAINFOL-01 study, showing promising efficacy for its investigational antibody-drug conjugate, rinatabart sesutecan (Rina-S®), in heavily pre-treated ovarian cancer patients. The data, presented at the 2025 Society of Gynecologic Oncology Annual Meeting, showed that patients receiving 120 mg/m² of Rina-S every three weeks achieved a confirmed objective response rate (ORR) of 55.6%, regardless of folate receptor-alpha (FRα) expression levels. With a median on-study follow-up of 48 weeks, most responses occurred early, and the median duration of response (mDOR) was not yet reached, suggesting durable efficacy. The disease control rate (DCR) was 88.9%, and only one patient in the treatment arm experienced disease progression.

Dr. Elizabeth Lee of Dana-Farber expressed optimism about Rina-S’s potential to improve outcomes for platinum-resistant ovarian cancer (PROC) patients, a group with historically poor prognoses. Genmab’s Chief Development Officer, Dr. Judith Klimovsky, highlighted the drug’s continued progress, with Phase 3 RAINFOL-02 trials set to further evaluate its impact. The treatment demonstrated a manageable safety profile, with common adverse events including anemia, nausea, and fatigue, but no new safety signals. As Genmab moves forward, Rina-S could represent a significant breakthrough for patients facing this aggressive disease.