New ADC improves overall survival in platinum-resistant ovarian cancer

Clinical takeaway: If approved, rinatabart sesutecan could become an important new treatment option for platinum-resistant ovarian cancer, improving both progression-free and overall survival versus chemotherapy in a phase 3 trial, regardless of FRα expression level.

Genmab reported positive topline results from the Phase 3 RAINFOL-02 trial evaluating the investigational folate receptor alpha (Faα)-targeted, topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC) rinatabart sesutecan (Rina-S) in patients with platinum-resistant ovarian cancer.

Participants were randomized to receive either Rina-S or investigator-selected standard-of-care chemotherapy on Day 1 of each three-week treatment cycle. Efficacy was evaluated in both the intent-to-treat population (ITT; n=584), which included all randomized patients regardless of FRα expression, and a prespecified primary analysis set (PAS; n=492), which included patients meeting additional FRα expression and prior mirvetuximab treatment criteria.

Compared with chemotherapy, Rina-S significantly improved progression-free survival and overall survival in both analysis populations. The risk of disease progression or death was reduced by 71% in the ITT population and by 67% in the PAS population, while the risk of death was reduced by 57% and 56%, respectively.

Importantly, these benefits were observed regardless of FRα expression level and irrespective of prior treatment with mirvetuximab, suggesting the therapy could benefit a broad range of patients with platinum-resistant disease.

According to the company, the safety findings were consistent with the known profile of Rina-S, with no new safety signals identified. The encouraging results add to growing interest in targeted therapies for ovarian cancer after platinum-based treatment failure.

The findings mark the first phase 3 readout from the broader Rina-S development program, which includes ongoing phase 3 trials in recurrent or progressive endometrial cancer (RAINFOL-03), platinum-sensitive ovarian cancer maintenance therapy (RAINFOL-04), second-line platinum-sensitive ovarian cancer (RAINFOL-07), and first-line ovarian cancer maintenance therapy (RAINFOL-10).

Genmab said the data will be submitted for presentation at a future medical meeting and have not yet been peer reviewed.

Source: Genmab. (2026 Oct 23). Genmab Announces Rinatabart Sesutecan (Rina-S®) Demonstrates Statistically Significant Improvement in Progression-Free Survival and Overall Survival in Patients with Platinum-Resistant Ovarian Cancer