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Joyce F. Liu, MD, MPH
Joyce F. Liu, MD, MPH
Posted: Wednesday, December 10, 2025
Presented during the European Society for Medical Oncology (ESMO) Congress 2025 (Abstract LBA42), the primary analysis of the phase II dose-optimization part of the REJOICE-Ovarian01 trial identified 5.6 mg/kg as the optimal dose for further evaluation of the antibody-drug conjugate raludotatug deruxtecan (R-DXd) in the ongoing phase III study in patients with platinum-resistant ovarian cancer. Isabelle L. Ray-Coquard, MD, PhD, of Centre Léon Bérard and Université Claude Bernard Lyon I, France, and colleagues highlighted its “promising” efficacy and manageable safety profile.
The trial enrolled a total of 107 patients with platinum-resistant high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer who had received one to three prior lines of systemic therapy (including bevacizumab and/or a PARP inhibitor, if eligible), irrespective of tumor CDH6 expression by immunohistochemistry. Patients were randomly assigned to receive an intravenous dose of R-DXd at 4.8 (n = 36), 5.6 (n = 36), or 6.4 (n = 35) mg/kg every 3 weeks until disease progression or unacceptable toxicity and stratified by prior lines of therapy and CDH6 expression. Patients had completed at least 18 weeks of follow-up or had discontinued treatment.
The median number of prior lines of therapy was three; a total of 83.2% and 70.1% of patients received bevacizumab and PARP inhibition, respectively. The median duration of treatment was 23.9 weeks.
Across doses, the objective response rate by blinded independent central review was 50.5%, including three (2.8%) complete responses—one at 4.8 mg/kg and two at 5.6 mg/kg. The investigators observed clinically meaningful responses across a range of tumor CDH6 expression levels. Nausea (69.2%), anemia (57.0%), and asthenia (46.7%) were the most frequently reported any-grade treatment-emergent adverse events. Treatment-related adverse events led to the delay, dose reduction, and discontinuation of R-DXd in 23.4%, 18.7%, and 5.6% of patients, respectively.
Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com.
