Keytruda fails to improve overall survival in advanced triple-negative breast cancer
MSD has made it known that its cancer immunotherapy Keytruda (pembrolizumab) failed to meet its primary endpoint in a Phase 3 study evaluating its efficacy as a monotherapy for the second- or third-line treatment of metastatic triple-negative breast cancer (TNBC).
The company revealed that the blockbuster anti-PD-1 drug failed to show superiority in improving overall survival compared to chemotherapy (capecitabine, eribulin, gemcitabine or vinorelbine). Because this primary endpoint was never met, all other endpoints were not formally tested. However, all safety data were found to be consistent with previous findings.
“Metastatic triple-negative breast cancer is an aggressive and challenging disease to treat, especially after progression on initial standard-of-care treatment,” commented Dr Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer at MSD. “While we are disappointed by the outcome of this monotherapy trial, we are continuing to study Keytruda in earlier stages of the disease and in combination with chemotherapy to address the unmet medical need of patients with triple negative breast cancer. We are grateful to the patients and investigators for their participation in this important study.”
It was confirmed that MSD would present full results of the study at an upcoming medical meeting.
AstraZeneca and Daiichi Sankyo have shared positive high-level results from the TROPION-Breast01 phase 3 trial, …
The Menarini Group and its subsidiary Stemline Therapeutics have announced that the European Commission (EC) …