Raludotatug Deruxtecan Trial Begins for Platinum-Resistant Ovarian Cancer Patients

A significant development has been reported in the field of oncology, with the initiation of the REJOICE-Ovarian01 phase 2/3 clinical trial. This trial is a collaborative effort between Daiichi Sankyo and Merck & Co., and it marks a crucial step in evaluating the potential of raludotatug deruxtecan (R-DXd), an investigational antibody-drug conjugate (ADC), for the treatment of platinum-resistant ovarian cancer.

The trial's phase 2 component aims to determine the optimal dosage of R-DXd, which will then be used in the phase 3 segment to compare its effectiveness against the standard chemotherapy options chosen by the investigators. R-DXd is a first-in-class CDH6-directed ADC, which has shown promising results in an earlier phase 1 trial. The drug was discovered by Daiichi Sankyo and is currently under joint development with Merck.

Ovarian cancer is a severe health concern, with a high recurrence rate following standard platinum-based chemotherapy treatments. The prognosis for advanced ovarian cancer is particularly grim, with a median overall survival of approximately two years and a five-year survival rate below 30%. Moreover, up to 85% of advanced ovarian tumors exhibit overexpression of CDH6, which is linked to a poorer prognosis.

The REJOICE-Ovarian01 trial is a global, multicenter, randomized, open-label study that will include patients with platinum-resistant, high-grade ovarian cancer who have received one to three prior systemic lines of anticancer therapy. The phase 2 part will assess the safety and tolerability of three different doses of R-DXd, with the primary endpoint being the objective response rate (ORR). The phase 3 part will then compare the efficacy and safety of R-DXd against chemotherapy, with dual primary endpoints of ORR and progression-free survival (PFS).

The study is expected to enroll around 650 patients from various regions, including Asia, Europe, North America, and South America. The results of this trial could potentially lead to a new treatment option for patients with platinum-resistant ovarian cancer, addressing an area of significant unmet medical need.

Daiichi Sankyo and Merck's collaboration began in October 2023, focusing on the joint development and commercialization of several ADCs, including R-DXd. This partnership aims to leverage the strengths of both companies to bring innovative treatments to cancer patients worldwide.

The DXd ADC portfolio of Daiichi Sankyo, which includes R-DXd, is designed to target and deliver a cytotoxic payload to cancer cells expressing specific cell surface antigens. This innovative approach to cancer treatment holds the potential to improve patient outcomes and expand the range of available therapies.

Both Daiichi Sankyo and Merck are committed to advancing the field of oncology, with a focus on developing and commercializing innovative medicines that can make a meaningful difference in the lives of cancer patients. The REJOICE-Ovarian01 trial represents a significant step forward in this ongoing pursuit of improved cancer treatments.