Phase 2/3 Study Launched for Raludotatug Deruxtecan in Platinum-Resistant Ovarian Cancer

Daiichi Sankyo and Merck & Co., under the name MSD outside the United States and Canada, have commenced the REJOICE-Ovarian01 phase 2/3 clinical trial, which has dosed the first patient. This trial is designed to assess the effectiveness and safety of the experimental drug raludotatug deruxtecan (R-DXd), a CDH6-targeting antibody-drug conjugate (ADC), in individuals with platinum-resistant ovarian cancer.

Raludotatug deruxtecan is a novel medication developed by Daiichi Sankyo and is being co-developed with Merck. It is a potential first-in-class treatment, specifically engineered to target the CDH6 protein, which is overexpressed in a significant number of advanced ovarian tumors and is linked to a poor prognosis.

The trial is initiated following the observation of a promising activity in a phase 1 study of raludotatug deruxtecan in patients with advanced ovarian cancer. The phase 2 segment will determine the appropriate dosage for the phase 3 segment, which will then compare the drug against the investigator's choice of chemotherapy.

The REJOICE-Ovarian01 trial is a global, multicenter, randomized, open-label study that will involve approximately 650 patients across multiple continents. It includes patients who have received one to three prior systemic lines of anticancer therapy, including those with documented high-folate receptor alpha expression who have been treated with mirvetuximab soravtansine.

The phase 2 part will focus on the safety and tolerability of three different doses of raludotatug deruxtecan to establish the recommended dose for phase 3. The primary outcome measure will be the objective response rate (ORR), as determined by a blinded independent central review (BICR). Secondary endpoints encompass various measures such as duration of response, progression-free survival, disease control rate, and overall survival.

In the phase 3 part, the efficacy and safety of the selected dose of raludotatug deruxtecan will be compared against chemotherapy options. The dual primary endpoints will be ORR and progression-free survival (PFS), both assessed by BICR, with additional pharmacokinetic and biomarker endpoints being evaluated.

The collaboration between Daiichi Sankyo and Merck aims to advance the development and commercialization of several ADCs, including raludotatug deruxtecan. This partnership builds upon the existing efforts to provide innovative treatment options for various types of cancer.

Ovarian cancer remains a significant health concern, with a high recurrence rate and limited treatment options for those who develop resistance to standard platinum-based chemotherapy. The development of targeted therapies like raludotatug deruxtecan is crucial in offering new hope for improved survival outcomes for these patients.

Daiichi Sankyo's DXd ADC portfolio, which includes raludotatug deruxtecan, represents a commitment to innovative cancer treatments. The company's focus is on creating new standards of care for patients with unmet medical needs, leveraging over a century of experience in the healthcare industry.

Merck's dedication to oncology is evident through its extensive development programs and strategic acquisitions aimed at advancing the prevention and treatment of diseases, including cancer. The company's mission is to translate scientific breakthroughs into innovative medicines that can make a meaningful difference in the lives of cancer patients worldwide.