Daiichi Sankyo and Merck announced that the first patient has been dosed in the REJOICE-Ovarian01 phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. The phase 2 portion of the trial will be conducted to identify the dose of raludotatug deruxtecan to be used in the phase 3 part of the trial, which will evaluate raludotatug deruxtecan versus investigator?s choice of chemotherapy. Raludotatug deruxtecan is an investigational specifically engineered potential first-in-class CDH6 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed with Merck.

Between 70% and 80% of patients diagnosed with advanced ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens. The median overall survival for advanced ovarian cancer following recurrence is approximately two years, with a five-year survival rate of less than 30%. Up to 85% of advanced ovarian tumors have overexpression of CDH6, which is associated with poor prognosis.

The initiation of REJOICE-Ovarian01 is based on results from an ongoing phase 1 trial of raludotatug deruxtecan presented at the European Society for Medical Oncology Congress 2023 with a subgroup analysis presented at the Society for Gynecologic Oncology (SGO) 2024 Annual Meeting on Women?s Cancer.