A phase 3 trial evaluating pembrolizumab, an anti-programmed death receptor-1 (PD-1) therapy, in combination with olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) has been stopped due to futility.
The randomized, open-label KEYLYNK-010 trial (ClinicalTrials.gov Identifier: NCT03834519) was comparing the efficacy and safety of pembrolizumab (Keytruda) in combination with olaparib (Lynparza) to abiraterone acetate or enzalutamide in approximately 780 adults with mCRPC who were unselected for homologous recombination repair defects and had failed prior treatment. The coprimary endpoints were overall survival and radiographic progression free survival.
Results from a planned interim analysis showed that pembrolizumab plus olaparib did not demonstrate a benefit in overall survival or improvement in radiographic progression free survival when compared with either abiraterone acetate or enzalutamide. The combination was also associated with a higher incidence of grade 3-5 adverse events and drug-related serious adverse events.
“There remains a significant unmet need for patients diagnosed with advanced prostate cancer, who have a poor prognosis after not responding to initial therapy,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “Merck continues to evaluate the combination of Keytruda and Lynparza in a range of cancers, and to research other Keytruda-based combinations for patients with advanced prostate cancer.”
Merck announces KEYLYNK-010 Trial evaluating Keytruda® (pembrolizumab) in combination with Lynparza® (olaparib) in patients with metastatic castration-resistant prostate cancer to stop for futility. News release. Merck & Co., Inc. Accessed March 15, 2022. https://www.businesswire.com/news/home/20220315005614/en/Merck-Announces-KEYLYNK-010-Trial-Evaluating-KEYTRUDA%C2%AE-pembrolizumab-in-Combination-with-LYNPARZA%C2%AE-olaparib-in-Patients-with-Metastatic-Castration-Resistant-Prostate-Cancer-to-Stop-for-Futility