Journal article
Pembrolizumab (pembro) plus enzalutamide (enza) for enza-resistant metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-199 cohorts 4-5.
- Graff, Julie Nicole OHSU Knight Cancer Institute, Portland, OR;
- Antonarakis, Emmanuel S. Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD;
- Hoimes, Christopher J. UH Cleveland Medical Center, Cleveland, OH;
- Tagawa, Scott T. VIVO-Weill Cornell Medical College, New York, NY;
- Hwang, Clara Henry Ford Health System, Detroit, MI;
- Kilari, Deepak Medical College of Wisconsin, Milwaukee, WI;
- Ten Tije, AJ Erasmus University Medical Center, Rotterdam, Netherlands;
- Omlin, Aurelius Gabriel Kantonsspital St. Gallen, St. Gallen, Switzerland;
- McDermott, Raymond S. Tallaght University Hospital, Dublin, Ireland;
- Vaishampayan, Ulka N. Karmanos Cancer Institute, Wayne State University, Detroit, MI;
- Elliott, Anthony NHS Foundation Trust, Manchester, United Kingdom;
- Wu, Helen Merck & Co., Inc., Kenilworth, NJ;
- Kim, Jeri Merck & Co., Inc., Kenilworth, NJ;
- Schloss, Charles Merck & Co., Inc., Kenilworth, NJ;
- De Bono, Johann S. Royal Marsden Hospital, London, United Kingdom;
Published in:
- Journal of Clinical Oncology. - American Society of Clinical Oncology (ASCO). - 2020, vol. 38, no. 6_suppl, p. 15-15
English
15 Background: KEYNOTE-199 (NCT02787005) is a multicohort phase 2 study. Cohort (C)4 (RECIST-measurable disease) and C5 (bone-predominant disease) consist of chemotherapy-naive patients (pts) with mCRPC treated with enza + pembro after progression with enza. Results for C4 and C5 presented. Methods: Pts with or without prior abiraterone had clinically meaningful response/benefit to enza followed by disease progression. Pts received pembro 200 mg Q3W with continuation of enza for up to 35 cycles or until progression/intolerable toxicity. Primary end point: ORR, blinded independent central review (C4). Secondary end points: DCR, PSA response rate (≥50% reduction), rPFS, OS, and safety (C4, C5); DOR (C4). Results: Of 126 pts (C4, 81; C5, 45), 107 discontinued, primarily due to progression. Median follow-up: 13.7 mo (C4, 11.8; C5, 18.6). ORR (95% CI) for pts with measurable disease was 12% (6-22) in C4; DCR for all pts: 51% (39-62) in C4 and 51% (36-66) in C5 (Table). Any grade/grade 3-5 treatment-related AEs occurred in 75%/26% pts in C4 and 69%/24% in C5. Two pts in C4 died of immune-related AEs (Miller Fisher syndrome and myasthenia gravis). Incidence of any grade/grade 3-4 rash (regardless of treatment relatedness) was higher than previously reported for individual agents (33%/6%). All except one pt (grade 3 treated with IV steroids) were treated with oral/topical steroids or had no intervention. Conclusions: Addition of pembro to enza following enza resistance showed modest antitumor activity in pts with RECIST-measurable and bone-predominant mCRPC. Combination had manageable safety and is being evaluated in a phase 3 trial. Clinical trial information: NCT02787005. [Table: see text]
- Language
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- English
- Open access status
- closed
- Identifiers
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- DOI 10.1200/jco.2020.38.6_suppl.15
- ISSN 0732-183X
- Persistent URL
- https://sonar.ch/global/documents/63242
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