Show simple item record

dc.contributor.authorHoimes, C. J.
dc.contributor.authorGraff, J. N.
dc.contributor.authorTagawa, S. T.
dc.contributor.authorHwang, C.
dc.contributor.authorKilari, D.
dc.contributor.authorTen Tije, A. J.
dc.contributor.authorOmlin, A.
dc.contributor.authorMcDermott, R. S.
dc.contributor.authorVaishampayan, U. N.
dc.contributor.authorElliott, Tony
dc.contributor.authorGerritsen, W. R.
dc.contributor.authorWu, H. Y.
dc.contributor.authorKim, J.
dc.contributor.authorSchloss, C.
dc.contributor.authorDe Bono, J. S.
dc.contributor.authorAntonarakis, E. S.
dc.date.accessioned2020-11-16T07:49:10Z
dc.date.available2020-11-16T07:49:10Z
dc.date.issued2020en
dc.identifier.citationHoimes CJ, Graff JN, Tagawa ST, Hwang C, Kilari D, Ten Tije AJ, et al. 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). Journal of Clinical Oncology. 2020;38(15)en
dc.identifier.urihttp://hdl.handle.net/10541/623391
dc.description.abstractBackground: 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.en
dc.language.isoenen
dc.titleKEYNOTE-199 cohorts (C) 4 and 5: Phase II study of pembrolizumab (pembro) plus enzalutamide (enza) for enza-resistant metastatic castration-resistant prostate cancer (mCRPC)en
dc.typeMeetings and Proceedingsen
dc.contributor.departmentDuke Cancer Institute, Durham, NC;en
dc.identifier.journalJournal of Clinical Oncologyen
dc.description.noteen]


This item appears in the following Collection(s)

Show simple item record