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Can Pembrolizumab Plus Olaparib Improve Survival in Pretreated Metastatic Castration-Resistant Prostate Cancer?

By: Julia Fiederlein Cipriano, MS
Posted: Wednesday, September 6, 2023

In patients with biomarker-unselected, heavily pretreated metastatic castration-resistant prostate cancer, Emmanuel S. Antonarakis, MD, of Masonic Cancer Center, University of Minnesota, Minneapolis, and colleagues found that treatment with pembrolizumab plus olaparib did not significantly improve radiographic progression–free or overall survival versus next-generation hormonal therapy. The results of the phase III KEYLYNK-010 trial, which were published in the Journal of Clinical Oncology, did not reveal any new safety signals.

“The study was stopped for futility,” the investigators remarked. “A clear unmet need remains for additional effective treatment options for previously treated metastatic castration-resistant prostate cancer, and studies are continually exploring how to best deploy immune checkpoint antibodies in the prostate cancer treatment continuum.”

Patients who experienced disease progression during or after treatment with abiraterone or enzalutamide, but not both, and docetaxel were randomly assigned in a 2:1 ratio to receive pembrolizumab plus olaparib (n = 529) or next-generation hormonal therapy with either abiraterone or enzalutamide (n = 264). At the final primary endpoint analyses, pembrolizumab plus olaparib did not appear to significantly prolong the median durations of radiographic progression–free (4.4 vs. 4.2 months; hazard ratio [HR] = 1.02; P = .55) or overall (15.8 vs. 14.6 months; HR = 0.94; P = .26) survival versus next-generation hormonal therapy.

The final median duration of time to first subsequent therapy was 7.2 months with pembrolizumab plus olaparib and 5.7 months with next-generation hormonal therapy (HR = 0.86). The objective response rates were 16.8% and 5.9%, respectively. Treatment-related adverse events of grade 3 or higher were reported more frequently with pembrolizumab plus olaparib than with next-generation hormonal therapy (34.6% vs. 9.0%).

Disclosure: For full disclosures of the study authors, visit

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