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Generation of Prostate Cancer Cell Models of Resistance to the Anti-mitotic Agent Docetaxel
Published on: September 8, 2017
KEYNOTE-921: Phase III study of pembrolizumab plus docetaxel for metastatic castration-resistant prostate cancer
Daniel P Petrylak1, Raffaele Ratta2, Rustem Gafanov3
1Department of Internal Medicine, Smilow Cancer Hospital, Yale School of Medicine, New Haven, CT 06511, USA.
Abstract:
Despite recent advances, treatment options for men with metastatic castration-resistant prostate cancer (mCRPC) progressing after next-generation hormonal agents (NHAs) are limited and provide only modest survival benefit. Thus, an unmet need remains for mCRPC patients after treatment with targeted endocrine therapy or NHA therapy. Pembrolizumab, a humanized monoclonal antibody for PD-1, has been found to have activity as monotherapy in patients with mCRPC and as combination therapy in a Phase Ib/II study with docetaxel and prednisone/prednisolone for patients previously treated with enzalutamide or abiraterone acetate. The aim of the randomized, double-blind, Phase III KEYNOTE-921 study is to evaluate the efficacy and safety of pembrolizumab plus docetaxel in patients with mCRPC who were previously treated with an NHA. Clinical trial registration: NCT03834506 (ClinicalTrials.gov).
Insights
This study investigates pembrolizumab plus docetaxel for metastatic castration-resistant prostate cancer (mCRPC) after next-generation hormonal agents. It aims to improve survival for patients with limited treatment options.
Area of Science:
- Oncology
- Immunotherapy
- Prostate Cancer Research
Background:
- Metastatic castration-resistant prostate cancer (mCRPC) presents limited treatment options for patients progressing after next-generation hormonal agents (NHAs).
- An unmet clinical need exists for effective therapies in this patient population.
- Pembrolizumab, an anti-PD-1 antibody, has shown prior activity in mCRPC, both as monotherapy and in combination regimens.
Purpose of the Study:
- To evaluate the efficacy and safety of pembrolizumab combined with docetaxel.
- To assess this combination in patients with mCRPC previously treated with an NHA.
Main Methods:
- A randomized, double-blind, Phase III clinical trial (KEYNOTE-921).
- Participants received either pembrolizumab plus docetaxel or placebo plus docetaxel.
- Patients had mCRPC and prior treatment with an NHA.
Main Results:
- Efficacy and safety data are currently being collected and analyzed.
- The study aims to determine if the combination improves overall survival or progression-free survival compared to docetaxel alone.
- Specific outcome data will be reported upon study completion.
Conclusions:
- The KEYNOTE-921 study will provide crucial data on the role of pembrolizumab plus docetaxel for mCRPC patients post-NHA therapy.
- Results are anticipated to inform future treatment strategies for this challenging cancer.
- This research addresses a significant unmet need in advanced prostate cancer care.
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