Journal article
KEYNOTE-199 cohorts (C) 4 and 5: Phase II study of pembrolizumab (pembro) plus enzalutamide (enza) for enza-resistant metastatic castration-resistant prostate cancer (mCRPC).
- Hoimes, Christopher J. Duke Cancer Institute, Durham, NC;
- Graff, Julie N OHSU Knight Cancer Institute, Portland, OR;
- Tagawa, Scott T. 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, A. J. Erasmus MC, Rotterdam, Netherlands;
- Omlin, Aurelius Kantonsspital St. Gallen, St. Gallen, Switzerland;
- McDermott, Raymond S. Tallaght University Hospital, Dublin, Ireland;
- Vaishampayan, Ulka N. Karmanos Cancer Institute, Detroit, MI;
- Elliott, Tony The Royal Marsden NHS Foundation Trust, Manchester, United Kingdom;
- Gerritsen, Winald R. Radboud University Medical Center, Nijmegen, Netherlands;
- Wu, Haiyan Merck & Co., Inc., Kenilworth, NJ;
- Kim, Jeri Merck & Co., Inc., Kenilworth, NJ;
- Schloss, Charles Merck & Co., Inc., Kenilworth, NJ;
- De Bono, Johann S. The Royal Marsden Hospital and The Institute of Cancer Research, London, United Kingdom;
- Antonarakis, Emmanuel S. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD;
Published in:
- Journal of Clinical Oncology. - American Society of Clinical Oncology (ASCO). - 2020, vol. 38, no. 15_suppl, p. 5543-5543
English
5543 Background: Initial evidence suggests activity of pembro + enza in patients (pts) resistant to enza. We present results from the multicohort phase II study KEYNOTE-199 (NCT02787005) in chemotherapy-naive pts with mCRPC treated with pembro + enza after progression with enza and who had RECIST-measurable (C4) or bone-predominant (C5) disease. Methods: Pts who did or did previously receive abiraterone and for whom enza treatment failed after clinically meaningful response received pembro 200 mg Q3W, with continuation of enza for up to 2 y or until progression, toxicity, or withdrawal. End point was ORR per RECIST v1.1 (C4) by blinded independent central review (primary); DOR (C4), time to PSA progression, rPFS, OS, and safety. Results: A total of126 pts (C4, 81; C5, 45) were treated. Median (range) PSA was 31 ng/mL (0.4-1667) in C4 and 19 ng/mL (1-1750) in C5.Median (range) time from enrollment to data cut off was 15 mo (7-21) in C4 and 19 mo (7-21) in C5. In C4, ORR (95% CI) was 12% (6-22; 2 CRs, 8 PRs) and median (range) DOR was 6 mo (3+ to 13); 60% of pts had DOR ≥6 mo. DCR (CR + PR + SD) was 51% in C4 and C5. Median (95% CI) time to PSA progression was 4 mo (4-4) in C4 and 4 mo (4-4) in C5. Median (95% CI) rPFS was 4 mo (3-6) for C4 and 4 mo (3-6) for C5; 12-mo rPFS rate was 17% in C4 and 23% in C5. Median (95% CI) OS was NR (16-NR) in C4 and 19 (14-NR) mo in C5; 12-mo OS rate was 70% in C4 and 75% in C5. Shorter median OS was more associated with prior enza treatment <6 mo than with prior enza treatment ≥6 mo. Liver metastasis was associated with shorter median OS however, median OS in visceral disease subgroups appeared longer than expected. Any-grade/grade ≥3 treatment-related AEs occurred in 75%/26% of pts in C4 and 69%/24% in C5. Two pts in C5 died of immune-related AEs (Miller Fisher syndrome and myasthenia gravis). Any-grade/grade 3/4 rash (regardless of relatedness) was higher than that in prior reports for individual agents (33%/6%). Conclusions: Pembro + enza after enza resistance had manageable safety and showed antitumor activity for RECIST-measurable and bone-predominant mCRPC. This combination is being evaluated in an ongoing phase III combination 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.2020.38.15_suppl.5543
- ISSN 0732-183X
- Persistent URL
- https://folia.unifr.ch/global/documents/133660
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