Daiichi Sankyo and Merck (MSD) have dosed the first subject in the global Phase II/III REJOICE-Ovarian01 clinical trial of raludotatug deruxtecan (R-DXd) in platinum-resistant, ovarian cancer patients.
Discovered by Daiichi Sankyo and being co-developed by the companies, R-DXd is an investigational antibody-drug conjugate (ADC) targeting human cadherin-6 (CDH6).
The multicentre, randomised, open-label trial will assess the efficacy and safety of the ADC in approximately 650 subjects across Europe, Asia, North America, and South America.
Participants will include those with primary peritoneal or fallopian tube cancer, having received one to three systemic anticancer therapies previously.
In the Phase II segment of the trial, the tolerability and safety of three doses of R-DXd will be analysed to detect the recommended dose.
The primary endpoint of this portion of the trial is the objective response rate (ORR), while secondary endpoints include the investigator's ORR, duration of response, progression-free survival (PFS), and disease control rate.
The subsequent Phase III part will compare the efficacy and safety of the chosen R-DXd dose against the investigator's choice of chemotherapy.
ORR and PFS will be the trial’s dual primary endpoints.
The trial's initiation follows data from an ongoing Phase I study of R-DXd.
Daiichi Sankyo oncology clinical development global head Mark Rutstein said: “Raludotatug deruxtecan has shown promising activity in a Phase I trial of patients with advanced ovarian cancer.
“The REJOICE-Ovarian01 trial, which is our first trial initiation for raludotatug deruxtecan in collaboration with Merck, will evaluate the efficacy of this CDH6 directed DXd antibody-drug conjugate versus investigator’s choice of chemotherapy in patients with platinum-resistant ovarian cancer.”
Prior to this development, the US Food and Drug Administration has accepted AstraZeneca and Daiichi Sankyo‘s biologics licence application for datopotamab deruxtecan for treating a subset of breast cancer patients.
