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GU cancers
CLEAR trial | 2021 | RCC - advanced |
Checkmate 9ER trial | 2021 | RCC - advanced |
ASSURE trial (ECOG-ACRIN E2805) | 2016 | RCC - perioperative |
S-TRAC trial | 2016 | RCC - perioperative |
PROTECT trial | 2017 | RCC - perioperative |
*KEYNOTE-564 trial | 2021 | RCC - perioperative |
**CheckMate 914 trial | 2021 | RCC - perioperative |
CLEAR trial
Motzer R et al, NEJM, 2021; PMID:33616314
RCC - advanced
Background: phase III RCT included 1,069 patients (Fav: 31%, INT 60%, POOR: 9%; ~1/3 had PDL1+score) metastatic RCC
Arm A: Lenvatinib 20mg daily plus pembrolizumab 200mg IV q3w
Arm B: Lenvatinib 18mg PO daily plus everolimus 5mg PO daily
Arm C: Sunitinib 50mg 4wk on, 2wk off
Primary end point: PFS
mFollow up: 26.6mo
mPFS for arm A vs C: 23.9mo vs 9.2mo, HR 0.39, 95%CI 0.32-0.49; P<.001;
mPFS for arm B vs C: 14.7mo vs. 9.2mo, HR 0.65, 95%CI 0.53-0.80, P<.001
mOS for arm A vs C: HR 0.66; 95%CI 0.49-0.88; P=.005
mOS for arm B vs C: HR 1.15; 95%CI 0.88-1.50; P=.30
Conclusions: Lenvatinib and pembrolizumab combination improved mPFS and mOS in patients with metastatic RCC
Summarized by Veli Bakalov, MD
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