Phase 3 REJOICE-Ovarian04 tests CDH6-targeted raludotatug deruxtecan maintenance with or without bevacizumab

Merck Sharp & Dohme is running this randomized, open-label Phase 3 study of raludotatug deruxtecan (R-DXd; MK-5909), a CDH6-directed antibody-drug conjugate developed with Daiichi Sankyo that delivers a topoisomerase I inhibitor payload. After response to first-line platinum-based chemotherapy, patients are assigned to R-DXd plus bevacizumab, R-DXd alone, or standard care consisting of bevacizumab maintenance or observation, as specified by the protocol and prior treatment.

The population has newly diagnosed stage III/IV ovarian, fallopian tube, or primary peritoneal cancer that is non-HRD-positive on the required assessment. Importantly, HRD-positive, unknown, and inconclusive results are excluded; an unavailable HRD result is not equivalent to HRD-negative eligibility. The key question is whether ADC maintenance improves progression-free survival while maintaining an acceptable safety profile. Bringing CDH6-directed cytotoxic delivery into frontline maintenance is distinct from treating measurable late-line recurrence and requires evidence that prolonged exposure provides sufficient benefit to justify added toxicity.