PLLBA-01 PEMBROLIZUMAB (PEMBRO) VS PLACEBO AS POST NEPHRECTOMY ADJUVANT THERAPY FOR PATIENTS (pts) WITH RENAL CELL CARCINOMA (RCC): RANDOMIZED, DOUBLE-BLIND, PHASE 3 KEYNOTE-564 STUDY

You have accessJournal of UrologyPlenary - Late-breaking Abstracts1 Sep 2021PLLBA-01 PEMBROLIZUMAB (PEMBRO) VS PLACEBO AS POST NEPHRECTOMY ADJUVANT THERAPY FOR PATIENTS (pts) WITH RENAL CELL CARCINOMA (RCC): RANDOMIZED, DOUBLE-BLIND, PHASE 3 KEYNOTE-564 STUDY Toni Choueiri, Piotr Tomczak, Se Hoon Park, Balaji Venugopal, Thomas Ferguson, Yen-Hwa Chang, Jaroslav Hajek, Stefan N. Symeonides, Jae Lyun Lee, Naveed Sarwar, Antoine Thiery-Vuillemin, Marine Gross-Goupil, Mauricio Mahave, Naomi Haas, Piotr Sawrycki, Pingye Zhang, Kentaro Imai, Jaqueline Willemann-Rogerio, David Quinn, and Thomas Powles Toni ChoueiriToni Choueiri More articles by this author , Piotr TomczakPiotr Tomczak More articles by this author , Se Hoon ParkSe Hoon Park More articles by this author , Balaji VenugopalBalaji Venugopal More articles by this author , Thomas FergusonThomas Ferguson More articles by this author , Yen-Hwa ChangYen-Hwa Chang More articles by this author , Jaroslav HajekJaroslav Hajek More articles by this author , Stefan N. SymeonidesStefan N. Symeonides More articles by this author , Jae Lyun LeeJae Lyun Lee More articles by this author , Naveed SarwarNaveed Sarwar More articles by this author , Antoine Thiery-VuilleminAntoine Thiery-Vuillemin More articles by this author , Marine Gross-GoupilMarine Gross-Goupil More articles by this author , Mauricio MahaveMauricio Mahave More articles by this author , Naomi HaasNaomi Haas More articles by this author , Piotr SawryckiPiotr Sawrycki More articles by this author , Pingye ZhangPingye Zhang More articles by this author , Kentaro ImaiKentaro Imai More articles by this author , Jaqueline Willemann-RogerioJaqueline Willemann-Rogerio More articles by this author , David QuinnDavid Quinn More articles by this author , and Thomas PowlesThomas Powles More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002150.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Effective therapy to reduce risk of RCC relapse after surgery remains an unmet need. Adjuvant immune therapy is a potential strategy for these pts. The KEYNOTE-564 trial (NCT03142334) evaluated pembro vs placebo as adjuvant therapy for pts with RCC. METHODS: KEYNOTE-564 is a phase 3 trial of pembro vs placebo for ≤17 cycles (≈1 yr) in pts with histologically confirmed clear cell RCC, with pT2, Gr 4 or sarcomatoid, N0 M0; pT3 or pT4, any Gr, N0 M0; any pT, any Gr, N+M0; or M1 NED (no evidence of disease after primary tumor + soft tissue metastases completely resected ≤1 yr from nephrectomy). Pts had undergone surgery ≤12 wks prior to randomization; had no prior systemic therapy; had ECOG PS 0 or 1. The primary endpoint was disease-free survival (DFS) per investigator assessment in all randomized pts (ITT population). Overall survival (OS) was a key secondary endpoint. Safety in all treated pts was a secondary endpoint. RESULTS: 994 pts were randomized 1:1 to pembro (n=496) or placebo (n=498). Median (range) time from randomization to data cutoff date of Dec 14, 2020 was 24.1 (14.9−41.5) mo. No pts remained on study treatment. Baseline characteristics were generally balanced between arms. At first prespecified interim analysis, the primary endpoint of DFS was met (median not reached [NR] for both arms, HR 0.68, 95% CI 0.53−0.87; p=0.0010 [one-sided]). Estimated DFS rate at 24 mo was 77.3% with pembro vs 68.1% with placebo. Overall, DFS benefit was consistent across subgroups. 51 OS events were observed (18 in the pembro arm, 33 in the placebo arm). Median OS was NR for both arms (HR 0.54, 95% CI 0.30−0.96; p=0.0164 [one-sided]); the p-value did not cross the statistical hypothesis testing boundary. Estimated OS rate at 24 mo was 96.6% with pembro vs 93.5% with placebo. 470 pts (96.3%) and 452 pts (91.1%) experienced ≥1 all-cause adverse events (AEs) with pembro vs placebo, respectively. Grade 3-5 all-cause AEs occurred in 158 pts (32.4%) with pembro and 88 pts (17.7%) with placebo. No deaths related to pembro occurred. CONCLUSIONS: Pembro demonstrated a statistically significant and clinically meaningful improvement in DFS vs placebo in pts with RCC at high risk of recurrence following surgery. Additional follow-up is planned for the key secondary endpoint of OS. KEYNOTE-564 is the first positive phase 3 study with adjuvant immunotherapy in RCC and these results support pembro as a potential new standard of care for pts with RCC in the adjuvant setting. Source of Funding: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1181-e1181 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Toni Choueiri More articles by this author Piotr Tomczak More articles by this author Se Hoon Park More articles by this author Balaji Venugopal More articles by this author Thomas Ferguson More articles by this author Yen-Hwa Chang More articles by this author Jaroslav Hajek More articles by this author Stefan N. Symeonides More articles by this author Jae Lyun Lee More articles by this author Naveed Sarwar More articles by this author Antoine Thiery-Vuillemin More articles by this author Marine Gross-Goupil More articles by this author Mauricio Mahave More articles by this author Naomi Haas More articles by this author Piotr Sawrycki More articles by this author Pingye Zhang More articles by this author Kentaro Imai More articles by this author Jaqueline Willemann-Rogerio More articles by this author David Quinn More articles by this author Thomas Powles More articles by this author Expand All Advertisement Loading ...