LBA02-08 RESULTS FROM THE EXTENDED FOLLOW-UP IN PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER IN THE CHeckMATE 274 TRIAL

You have accessJournal of UrologyCME1 Apr 2023LBA02-08 RESULTS FROM THE EXTENDED FOLLOW-UP IN PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER IN THE CHeckMATE 274 TRIAL Matthew Milowsky, Matthew D. Galsky, Dean F. Bajorin, Johannes Alfred Witjes, Jürgen E. Gschwend, Michael Schenker, Craiova Romania, Begoña P. Valderrama, Yoshihiko Tomita, Aristotelis Bamias, Thierry Lebret, Shahrokh F. Shariat, Se Hoon Park, Mads Agerbaek, Frank Stenner, Margarita Askelson, Federico Nasroulah, Joshua Zhang, Lynne Brophy, and Gautam Jha Matthew MilowskyMatthew Milowsky More articles by this author , Matthew D. GalskyMatthew D. Galsky More articles by this author , Dean F. BajorinDean F. Bajorin More articles by this author , Johannes Alfred WitjesJohannes Alfred Witjes More articles by this author , Jürgen E. GschwendJürgen E. Gschwend More articles by this author , Michael SchenkerMichael Schenker More articles by this author , Craiova RomaniaCraiova Romania More articles by this author , Begoña P. ValderramaBegoña P. Valderrama More articles by this author , Yoshihiko TomitaYoshihiko Tomita More articles by this author , Aristotelis BamiasAristotelis Bamias More articles by this author , Thierry LebretThierry Lebret More articles by this author , Shahrokh F. ShariatShahrokh F. Shariat More articles by this author , Se Hoon ParkSe Hoon Park More articles by this author , Mads AgerbaekMads Agerbaek More articles by this author , Frank StennerFrank Stenner More articles by this author , Margarita AskelsonMargarita Askelson More articles by this author , Federico NasroulahFederico Nasroulah More articles by this author , Joshua ZhangJoshua Zhang More articles by this author , Lynne BrophyLynne Brophy More articles by this author , and Gautam JhaGautam Jha More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003361.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Despite radical resection, patients with muscle-invasive urothelial carcinoma (MIUC) remain at high risk for lethal metastatic recurrence, mostly within 2–3 years of surgery. CheckMate 274 is a phase 3, randomized, double-blind trial of adjuvant nivolumab (NIVO) vs placebo (PBO) in high-risk MIUC after radical resection. The 2 primary endpoints (disease-free survival [DFS] in intent-to-treat [ITT] patients [pts] and in pts with tumor programmed death ligand 1 [PD-L1] expression ≥ 1%) were met. At minimum follow-up of 11.0 months (median: 23.3 months), DFS benefit with NIVO vs PBO was observed in ITT pts (HR 0.70; 95% CI 0.57–0.85) and in pts with PD-L1 ≥ 1% (HR 0.53; 95% CI 0.38–0.75); efficacy benefits (DFS [HR 0.61; 95% CI 0.49–0.77], non-urothelial tract recurrence-free survival [NUTRFS], and distant metastasis-free survival [DMFS]) were also seen in pts with muscle invasive bladder cancer (MIBC). We report extended follow-up results for pts with MIBC (minimum: 31.6 months [median: 36.1 months] in the ITT population). METHODS: Pts were randomized 1:1 to NIVO 240 mg IV Q2W or PBO for ≤1 year of adjuvant treatment and stratified by nodal status, prior neoadjuvant cisplatin, and tumor PD-L1 expression. Pts had radical resection±neoadjuvant chemotherapy and were at high risk of recurrence. Primary endpoints are DFS in ITT pts and in pts with PD-L1 ≥1%. NUTRFS is a secondary endpoint. DMFS and safety are exploratory endpoints. Analysis of the MIBC subgroup is exploratory. RESULTS: Of 709 randomized pts, 560 had MIBC (NIVO, n=279; PBO, n=281). DFS was improved with NIVO vs PBO in all pts with MIBC (HR 0.63), and in the PD-L1 ≥1% (HR 0.44) and PD-L1 <1% (HR 0.74) subgroups (Table). HR favored NIVO vs PBO for NUTRFS (HR 0.64) and DMFS (HR 0.70) (Table). Grade 3–4 treatment-related adverse events occurred in 17.3% and 5.8% of NIVO and PBO arm pts, respectively. CONCLUSIONS: With extended 3-year median follow-up, continued improvement in DFS, NUTRFS, and DMFS were observed with NIVO vs PBO in pts with MIBC. DFS benefit was evident regardless of tumor PD-L1 expression. Safety was consistent with previous data in the ITT population with no new safety signals identified. These results further support NIVO as a standard of care for high-risk MIBC after radical resection. Source of Funding: Bristol Myers Squibb © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1189 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Matthew Milowsky More articles by this author Matthew D. Galsky More articles by this author Dean F. Bajorin More articles by this author Johannes Alfred Witjes More articles by this author Jürgen E. Gschwend More articles by this author Michael Schenker More articles by this author Craiova Romania More articles by this author Begoña P. Valderrama More articles by this author Yoshihiko Tomita More articles by this author Aristotelis Bamias More articles by this author Thierry Lebret More articles by this author Shahrokh F. Shariat More articles by this author Se Hoon Park More articles by this author Mads Agerbaek More articles by this author Frank Stenner More articles by this author Margarita Askelson More articles by this author Federico Nasroulah More articles by this author Joshua Zhang More articles by this author Lynne Brophy More articles by this author Gautam Jha More articles by this author Expand All Advertisement PDF downloadLoading ...