Genmab initiates Phase 3 RAINFOL-10 trial of Rina-S in first-line ovarian cancer maintenance

Genmab has initiated the Phase 3 RAINFOL-10 trial (NCT07859215), evaluating rinatabart sesutecan (Rina-S) with or without bevacizumab as first-line maintenance therapy for patients with newly diagnosed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have completed first-line platinum-based chemotherapy and are not candidates for PARP inhibitor maintenance.

Rina-S is an investigational folate receptor alpha (FRα)-directed antibody-drug conjugate carrying a topoisomerase I inhibitor payload. RAINFOL-10 is expected to enroll approximately 602 patients and will compare a Rina-S-containing regimen with standard maintenance therapy, consisting of bevacizumab or observation, depending on previous treatment and applicable clinical practice. The primary endpoint is progression-free survival assessed according to RECIST v1.1 by blinded independent central review.

The trial introduces Rina-S into the increasingly competitive first-line ovarian cancer maintenance setting.

From a competitive-intelligence perspective, this development is relevant to Gilead Sciences because Rina-S and TUB-040 are already positioned as potential competitors in platinum-resistant ovarian cancer, including through the Phase 3 RAINFOL-02 program for Rina-S. If TUB-040 is also expanded into first-line maintenance, RAINFOL-10 could position Rina-S as a direct future competitor in that setting.

Earlier use of topoisomerase I inhibitor-based ADCs during first-line maintenance could also affect treatment sequencing in recurrent disease, particularly the subsequent use of ADCs carrying the same payload class. Based on the reported study timeline and primary completion date, RAINFOL-10 may generate its primary results around 2030.

The initiation of RAINFOL-10 further demonstrates Genmab’s investment in the Rina-S development program. It represents the company’s fourth global Phase 3 trial of Rina-S in ovarian cancer, alongside two Phase 3 studies in endometrial cancer, and supports its strategy of building a portfolio of wholly owned products.

On October 3, 2026, Genmab also presented Phase 2 RAINFOL-01 data in 109 patients with platinum-resistant ovarian cancer. Rina-S monotherapy achieved a confirmed objective response rate of 45.9%, a median duration of response of 12.1 months, and a median progression-free survival of 9.5 months. Activity was observed across FRα expression levels. The most common treatment-emergent adverse events included gastrointestinal and hematologic events, and 55% of patients received G-CSF support.