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ESMO 2022: Pembrolizumab Plus Olaparib Under Study in Metastatic Castration-Resistant Prostate Cancer

By: Cordi Craig, MS
Posted: Wednesday, September 28, 2022

Few effective therapies exist for patients with heavily pretreated metastatic castration-resistant prostate cancer. Evan Y. Yu, MD, of the Seattle Cancer Care Alliance, and colleagues evaluated the safety and efficacy of pembrolizumab plus olaparib compared with abiraterone or enzalutamide among patients with metastatic castration-resistant prostate cancer following a next-generation hormonal agent and docetaxel. The results of the phase III KEYLYNK-010 study, presented at the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract 1362MO), indicated that pembrolizumab plus olaparib did not improve survival outcomes in this patient population, despite improvement of overall response rates.

The study authors randomly assigned 793 patients with metastatic castration-resistant prostate cancer on a 2:1 basis to receive pembrolizumab plus olaparib (n = 529) or a next-generation hormonal agent (n = 264), which consisted of abiraterone or enzalutamide. Patients were enrolled between May 2019 and July 2021. The study was stopped because of futile outcomes.

After a median follow-up of 11.9 months, radiographic progression-free and overall survival endpoints were not reached. The radiographic progression-free survival was 4.4 months versus 4.2 months with pembrolizumab plus olaparib and with a next-generation hormonal agent, respectively (P = .55). No significant difference was observed in overall survival (P = .26). However, the overall response rate was significantly higher among patients treated with pembrolizumab plus olaparib compared with a next-generation hormonal agent (17% vs. 6%, respectively; P = .002).

Severe treatment-related adverse events occurred in 35% of patients treated with pembrolizumab plus olaparib versus 9% in patients receiving a next-generation hormonal agent. Severe immune-mediated adverse events were reported in 5% and 1% of patients, respectively.

Disclosure: For full disclosures of the study authors, visit

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