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Phase II study of pembrolizumab (pembro) plus enzalutamide for enzalutamide (enza)-resistant metastatic castration-resistant prostate cancer (mCRPC): Cohorts (C) 4 and 5 update from KEYNOTE-199
Vaishampayan, U. N. Elliott, Tony Omlin, A. G. Graff, J. N. Hoimes, C. J. Tagawa, S. T. Hwang, C. Kilari, D. Ten Tije, A. J. McDermott, R. S.
Vaishampayan, U. N.
Elliott, Tony
Omlin, A. G.
Graff, J. N.
Hoimes, C. J.
Tagawa, S. T.
Hwang, C.
Kilari, D.
Ten Tije, A. J.
McDermott, R. S.
Citations
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Abstract
Background: Chemotherapy-naive patients (pts) with mCRPC who had disease progression
with enza were enrolled in C4 and C5 of the multicohort phase II KEYNOTE-
199 study (NCT02787005).
Methods: Pts who did or did not previously take abiraterone acetate were eligible if they
developed resistance to enza after prior response. Cohorts were composed of ptswho had
RECIST-measurable (C4) or bone-predominant nonmeasurable (C5) disease. Pts received
pembro 200 mg Q3W for up to 35 cycles + enza QD until progression, toxicity, or withdrawal.
The primary end point was ORR per RECIST v1.1 by blinded independent central
reviewin C4; DORwas also analyzed. Secondary end points (both cohorts)were DCR, rPFS,
OS, time to cytotoxic chemotherapy, time to new anticancer therapy, and safety.
Results: A total of 126 pts (C4, 81; C5, 45) were treated. Median (range) time from
enrollment to data cutoff was 15 mo (7-21) and 19 mo (7-21) in C4 and C5,
respectively. In C4, ORR (95% CI) was 12% (6-22) (2 CRs, 8 PRs) and median (range)
DOR was 6.3 mo (2.5+ to 13.4); 4 responders (73% by Kaplan-Meier estimation) had a
response 6 mo (Table). Median time to cytotoxic chemotherapy was 11.1 and 11.3
mo in C4 and C5, and time to PSA progression was 4.2 mo in both cohorts (Table). A
total of 26% and 24% of pts in C4 and C5, respectively, experienced grade 3
treatment-related adverse events (TRAEs). Two pts in C4 died of immune-related AEs
(Miller Fisher syndrome and myasthenia gravis). Incidence of any-grade/grade 3 or 4
rash (33%/6%), regardless of treatment relatedness, was higher than previously reported
for individual agents but manageable with standard-of-care treatments.
Description
Date
2020
Publisher
Collections
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From UNPAYWALL
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Keywords
Type
Meetings and Proceedings
Citation
Vaishampayan UN, Elliott T, Omlin AG, Graff JN, Hoimes CJ, Tagawa ST, et al. 227P Phase II study of pembrolizumab (pembro) plus enzalutamide for enzalutamide (enza)-resistant metastatic castration-resistant prostate cancer (mCRPC): Cohorts (C) 4 and 5 update from KEYNOTE-199. Annals of Oncology. 2020;31:S1330-S.