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GU cancers

Neoadjuvant MVAC
2003
Bladder - advanced
BC2001 trial, RT w/wo chemo
2012
Bladder - advanced
Keynote 045
2017
Bladder - advanced
Checkmate 275
2017
Bladder - advanced
Erdafitinib trial
2019
Bladder - advanced
JAVELIN Bladder 100 Trial
2020
Bladder - advanced
Keynote 052
2020
Bladder - advanced
EV 301 trial (Enfortumab Vedotin)
2021
Bladder - advanced
Intermittent Androgen suppression
2012
Prostate - advanced
Hero Trial
2020
Prostate - advanced
ENACT Trial, enza vs active surveillance
2022
Prostate - early stage
Docetaxel and Estramustine vs Mitoxantrone
2004
Prostate - metastatic
Affirm Trial
2012
Prostate - metastatic
Prevail Trial
2014
Prostate - metastatic
CHAARTED trial (docetaxel)
2015
Prostate - metastatic
Latitude Trial
2017
Prostate - metastatic
Titan Trial
2019
Prostate - metastatic
Enzamet Trial
2019
Prostate - metastatic
TheraP Trial
2021
Prostate - metastatic
Vision Trial
2021
Prostate - metastatic
ARASENS trial, Docetaxel+ADT +/- Darolutamide
2022
Prostate - metastatic
Sunitinib versus INF-alfa
2007
RCC - advanced
Temsirolimus vs INF-alfa trial
2007
RCC - advanced
IMDC analysis
2009
RCC - advanced
AXIS trial
2011
RCC - advanced
Axitinib dose titration
2013
RCC - advanced
EXIST-2 trial
2013
RCC - advanced
Lenvatinib trial
2015
RCC - advanced
CheckMate 025 trial
2015
RCC - advanced
Surveillance in m-RCC
2016
RCC - advanced
METEOR trial
2016
RCC - advanced
CABOSUN trial
2017
RCC - advanced
IMmotion151 trial
2019
RCC - advanced
CheckMate 214 trial
2020
RCC - advanced
KEYNOTE-426 trial
2020
RCC - advanced
JAVELIN Renal 101 trial
2020
RCC - advanced
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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