Related Experiment Video
Updated: Feb 8, 2026
Surgical Treatment for Benign Prostatic Hyperplasia: Holmium Laser Enucleation of the Prostate HoLEP.
Published on: March 6, 2018
Pembrolizumab for advanced prostate adenocarcinoma: findings of the KEYNOTE-028 study
A R Hansen1, C Massard2, P A Ott3
1Division of Medical Oncology, UHN Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
Background:
Patients with castration-resistant prostate cancer derive only modest clinical benefit from available therapies. Blockade of the inhibitory programmed death 1 (PD-1) receptor by monoclonal antibodies has been effective in several malignancies. Results from the prostate adenocarcinoma cohort of the nonrandomized phase Ib KEYNOTE-028 trial of pembrolizumab in advanced solid tumors are presented.
Materials And Methods:
Key eligibility criteria included advanced prostate adenocarcinoma, unsuccessful standard therapy, measurable disease per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1), and PD-1 ligand (PD-L1) expression in ≥1% of tumor or stromal cells. Patients received pembrolizumab 10 mg/kg every 2 weeks until disease progression or intolerable toxicity for up to 24 months. Primary end point was objective response rate (ORR) per RECIST v1.1 by investigator review.
Results:
Median patient age in this cohort (n = 23) was 65 years; 73.9% of patients received at least two prior therapies for metastatic disease. There were four confirmed partial responses, for an ORR of 17.4% [95% confidence interval (CI) 5.0%-38.8%]; 8 of 23 (34.8%) patients had stable disease. Median duration of response was 13.5 months. Median progression-free survival (PFS) and overall survival (OS) were 3.5 and 7.9 months, respectively; 6-month PFS and OS rates were 34.8% and 73.4%, respectively. One patient remained on treatment at data cutoff. After a median follow-up of 7.9 months, 14 (60.9%) patients experienced treatment-related adverse events (TRAEs), most commonly nausea (n = 3, 13.0%). Four (17.3%) experienced grade 3/4 TRAEs: grade 3 peripheral neuropathy, grade 3 asthenia, grade 3 fatigue, and grade 4 lipase increase. No pembrolizumab-related deaths or discontinuations occurred.
Conclusion:
Pembrolizumab resulted in durable objective response in a subset of patients with heavily pretreated, advanced PD-L1-positive prostate cancer, and its side effect profile was favorable.
Clinicaltrials.Gov Identifier:
NCT02054806.
Insights
Pembrolizumab showed durable response in advanced prostate cancer patients with PD-L1 expression. This immunotherapy demonstrated a favorable side effect profile in heavily pretreated individuals.
Area of Science:
- Oncology
- Immunotherapy
- Prostate Cancer Research
Background:
- Castration-resistant prostate cancer (CRPC) has limited treatment options.
- Programmed death 1 (PD-1) receptor blockade with monoclonal antibodies shows efficacy in various cancers.
- This study evaluates pembrolizumab in advanced prostate adenocarcinoma.
Purpose of the Study:
- To assess the efficacy and safety of pembrolizumab in patients with advanced prostate cancer.
- To determine the objective response rate (ORR) in a heavily pretreated CRPC cohort.
- To evaluate the duration of response, progression-free survival (PFS), and overall survival (OS).
Main Methods:
- A nonrandomized, phase Ib KEYNOTE-028 trial cohort of 23 patients with advanced prostate adenocarcinoma.
- Patients received pembrolizumab (10 mg/kg every 2 weeks) until disease progression or toxicity.
- Eligibility included prior unsuccessful therapy, measurable disease, and PD-L1 expression (≥1%).
- Objective response rate (ORR) per RECIST v1.1 was the primary endpoint.
Main Results:
- An objective response rate (ORR) of 17.4% (95% CI 5.0%-38.8%) was observed, with 4 partial responses.
- 34.8% of patients achieved stable disease, with a median duration of response of 13.5 months.
- Median PFS was 3.5 months and median OS was 7.9 months. Treatment-related adverse events (TRAEs) were mostly mild, with 17.3% experiencing grade 3/4 events.
Conclusions:
- Pembrolizumab demonstrated durable objective responses in a subset of heavily pretreated, advanced PD-L1-positive prostate cancer patients.
- The immunotherapy exhibited a favorable safety profile, with no treatment-related deaths or discontinuations.
- These findings support pembrolizumab as a potential therapeutic option for specific prostate cancer populations.
Related Concept Videos
01:03Finding the Center of Gravity
01:30Respiratory System Abnormal Finding I: Inspection and Percussion
Inspection Findings
During an inspection, several findings may suggest the presence of respiratory distress or disease. Pursed-lip breathing, where exhalation is slowed by...
01:13Finding Electric Potential From Electric Field
01:29Cardiovascular System Abnormal Findings I: Inspection and Palpation
Abnormal findings observed during an inspection
01:24Finding Volume Using Cross-Sectional Area
01:25Cardiovascular System Abnormal Findings II: Auscultation
Abnormal Heart Sounds
Gallops: