Phase 3 rinatabart sesutecan (Rina-S) FRα ADC delivering exatecan (topoisomerase I inhibitor)

Genmab’s open-label, randomized Phase 3 trial (NCT07564141; ~688 participants planned) tests rinatabart sesutecan (Rina-S)—a folate receptor alpha (FRα/FOLR1)–directed antibody-drug conjugate that delivers an exatecan-class topoisomerase I inhibitor payload—given every 3 weeks, with or without bevacizumab (Genentech/Roche VEGF-targeting antibody). The control arm is investigator’s choice platinum-based doublet chemotherapy (carboplatin + gemcitabine, paclitaxel, or pegylated liposomal doxorubicin) with or without bevacizumab, reflecting real-world second-line options in platinum-sensitive recurrence. The eligible population is recurrent high-grade platinum-sensitive ovarian cancer, including subgroups such as BRCA1/2-mutated or HRD-positive disease after prior PARP inhibitor exposure (a common modern scenario where post-PARPi platinum sensitivity remains clinically important). Commercially and scientifically, the key angle is whether an FRα-targeted topo1 ADC can outperform standard platinum rechallenge strategies (and potentially carve out a post-PARPi 2L niche) while allowing optional anti-VEGF intensification. Today’s care for recurrent platinum-sensitive ovarian cancer is typically platinum doublet re-treatment, often paired with bevacizumab and followed by maintenance (bevacizumab and/or PARP inhibitor when eligible), but outcomes after prior PARP inhibitor use are an area of active unmet need.