Loading...
KEYNOTE-199 phase II study of pembrolizumab plus enzalutamide for enzalutamide-resistant metastatic castration-resistant prostate cancer (mCRPC): Cohorts (C) 4 and 5 update
Omlin, A. G. Graff, J. N. Hoimes, C. J. Tagawa, S. T. Hwang, C. Kilari, D. Ten Tije, A. J. McDermott, R. 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.
Vaishampayan, U. N.
Elliott, Tony
Citations
Altmetric:
Abstract
Background: We present results including time to cytotoxic chemotherapy and time
to new anticancer therapy from the multicohort phase 2 study KEYNOTE-199
(NCT02787005) in chemotherapy-naive patients (pts) with mCRPC treated with
pembrolizumab (pembro) + enzalutamide (enza) after progression on enza and whoResults: 126 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 6.3 mo (2.5+ to 13.4); 4 responders
(73% by Kaplan-Meier estimation) had a response 6 mo. Efficacy analyses
are displayed in the table. Grade 3 treatment-related AEs occurred in 26% of pts in
C4 and 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%) but manageable with standard of care treatments.
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 the ongoing KEYNOTE-641 phase III trial
(NCT03834493).
had RECIST-measurable (C4) or bone-predominant nonmeasurable (C5) disease.
Methods: Pts with or without prior abiraterone were eligible if they developed
resistance to enza following prior response. Pts continued on enza and received
pembro 200 mg IV Q3W for up to 2 y or until progression, toxicity, or withdrawal. End
points: ORR per RECIST v1.1 (C4) by blinded independent central review (primary),
DOR (C4), DCR, rPFS per PCWG3-modified RECIST, OS, time to cytotoxic chemotherapy,
time to new anticancer therapy, and safety
Description
Date
2020
Publisher
Collections
Files
Loading...
From UNPAYWALL
Adobe PDF, 114.48 KB
Keywords
Type
Meetings and Proceedings
Citation
Omlin AG, Graff JN, Hoimes CJ, Tagawa ST, Hwang C, Kilari D, et al. 623P KEYNOTE-199 phase II study of pembrolizumab plus enzalutamide for enzalutamide-resistant metastatic castration-resistant prostate cancer (mCRPC): Cohorts (C) 4 and 5 update. Annals of Oncology. 2020;31:S514-S5.