Genmab’s Rina-S Phase 3 RAINFOL-02 trial meets PFS and OS endpoints
Genmab reported that its Phase 3 RAINFOL-02 trial of Rina-S in platinum-resistant ovarian cancer met progression-free-survival and overall-survival endpoints. The reported hazard ratios were 0.29 for progression-free survival and 0.43 for overall survival in the intention-to-treat population. Safety was consistent, and Genmab plans regulatory discussions.
The source directly reports that Genmab’s Phase 3 RAINFOL-02 trial of Rina-S (rinatabart sesutecan) in platinum-resistant ovarian cancer met both progression-free-survival and overall-survival endpoints, with hazard ratios of 0.29 and 0.43, respectively, in the intention-to-treat population. Consistent safety and planned regulatory discussions make this a new, material, forward-looking clinical catalyst, but no regulatory submission or approval is reported, so the development remains a clinical_study event rather than a regulatory_approval event. The source provides no separate trial-readout time, so the publication timestamp is used as the best estimate. The development is distinct from the earlier RAINFOL-01 results and continues the existing Rina-S clinical-development storyline. Approved stakeholders are limited to Genmab and companies with explicitly described direct or close FRα-ADC exposure; broader manufacturing, diagnostic, and unrelated oncology effects are excluded as too speculative.
Genmab reported Phase 3 RAINFOL-02 met PFS and OS endpoints for Rina-S in platinum-resistant ovarian cancer, with HR 0.29 for PFS in ITT and HR 0.43 for OS.
Safety was consistent; the company plans regulatory discussions.
The company said late Friday that its rinatabart sesutecan, or Rina-S, drug candidate met its primary and key secondary goals in the late-stage clinical trial by cutting the risk of death by 57% and of disease progression by 71%, compared to chemotherapy, in patients with an advanced form of ovarian cancer.