REJOICE-Ovarian01 phase II/III trial of raludotatug deruxtecan initiated in patients with platinum-resistant ovarian cancer.- Daiichi Sankyo + Merck Inc.
Daiichi Sankyo and Merck Inc., known as MSD outside of the United States and Canada, announced that the first patient has been dosed in the REJOICE-Ovarian01 Phase II/III trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer
The Phase II portion of the trial will be conducted to identify the dose of raludotatug deruxtecan to be used in the Phase III 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.
“Raludotatug deruxtecan has shown promising activity in a Phase 1 trial of patients with advanced ovarian cancer,” said Mark Rutstein, MD, global head, oncology clinical development, Daiichi Sankyo. “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.”
“The prognosis for the majority of patients diagnosed with advanced ovarian cancer is bleak, with a low five-year survival rate, underscoring the critical need for the development of innovative and effective therapies,” said Marjorie Green, MD, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “We look forward to working with our colleagues at Daiichi Sankyo to further evaluate the potential of raludotatug deruxtecan to provide a new treatment option for patients with platinum-resistant ovarian cancer.”
About the REJOICE-Ovarian01 trial : REJOICE-Ovarian01 is a global, multicenter, randomized, open-label Phase II/III trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant, high-grade ovarian cancer, including primary peritoneal or fallopian tube cancer, who received at least one and no more than three prior systemic lines of anticancer therapy, including prior treatment with mirvetuximab soravtansine for those with documented high-folate receptor alpha expression. The Phase II part of REJOICE-Ovarian01 will assess the safety and tolerability of three doses of raludotatug deruxtecan (4.8 mg/kg, 5.6 mg/kg, or 6.4 mg/kg) to identify the recommended dose for the Phase III part of the trial. The primary endpoint of the Phase II part of the trial is objective response rate (ORR) as assessed by blinded independent central review (BICR). Secondary endpoints include ORR as assessed by investigator, duration of response (DoR), progression free survival (PFS) and disease control rate (DCR) – all assessed by both BICR and investigator – and overall survival (OS).
The Phase III part of REJOICE-Ovarian01 will assess the efficacy and safety of raludotatug deruxtecan at the selected dose compared to investigator’s choice of chemotherapy (paclitaxel, pegylated liposomal doxorubicin, gemcitabine, or topotecan).
The dual primary endpoints of the Phase III part of the trial are ORR and PFS as assessed by BICR. Secondary endpoints include PFS and ORR as assessed by investigator, DoR and DCR as assessed by both BICR and investigator, and OS. Pharmacokinetic and biomarker endpoints also will be assessed in both parts of the trial. The trial is expected to enroll approximately 650 patients across Asia, Europe, North America and South America. .
About CDH6 : CDH6 (human cadherin-6) is a cadherin family protein overexpressed in several cancers, including ovarian tumors. An estimated 65% to 85% of patients with ovarian cancer have tumors that express CDH6, which is associated with poor prognosis. There is currently no CDH6 directed therapy approved for treatment of any cancer.
In addition to the REJOICE-Ovarian01 trial, raludotatug deruxtecan is being evaluated in a Phase 1 trial in advanced ovarian cancer as part of a strategic collaboration with Sarah Cannon Research Institute (SCRI) with study operational oversight and delivery provided through SCRI’s early phase oncology clinical research organization, SCRI Development Innovations in Nashville, TN.
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