7/3/2023 0 Comments Keynote 158Gurney: Financial Interests, Personal, Advisory Board: Merck, Ipsen, Pfizer, MSD, Astellas, Parexel, BMS, AstraZeneca, Janssen, Eisai, Amgen. Albiges: Financial Interests, Institutional, Other, Consulting: Astellas, AstraZeneca, BMS, EISAI, Ipsen, Janssen, MSD, Merck, Novartis, Pfizer Non-Financial Interests, Principal Investigator: Pfizer, BMS, Ipsen, AVEO, AstraZeneca, MSD Non-Financial Interests, Other, Clinical trial steering committee: Roche, Exelixis Non-Financial Interests, Member: ASCO Non-Financial Interests, Other, Medical Steering Committee: Kidney Cancer Association Non-Financial Interests, Other, Member of the Renal Cell Carcinoma Guidelines Panel: European Association of Urology (EAU) Non-Financial Interests, Other, Member of the Kidney Cancer Research Summit scientific committee 2021: Kidney Can Other, Scientific Committee: BMS France. Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and Eisai Inc., Nutley, NJ, USA. This assistance was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and Eisai Inc., Nutley, NJ, USA. Medical writing and/or editorial assistance was provided by Robert Steger, PhD, and Mallory Campbell, PhD, of ApotheCom (Yardley, PA, USA). No new safety signals emerged with this combination. In this preliminary analysis, pembro + lenva showed promising antitumor activity and manageable safety in pts with advanced nccRCC. Grade 3-4 TRAEs occurred in 51 pts (34.7%). In all treated pts (N=147), any grade treatment-related AEs (TRAEs) occurred in 127 pts (86.4%), most commonly hypertension (n=71 48.3%), diarrhea (n=37 25.2%), and hypothyroidism (n=37 25.2%). ORR and DCR in histologic subgroups are shown in the table. Median DOR was not reached (range, 1.4+ to 7.2+ mo). As of January 31, 2022, median follow-up for pts who had the opportunity for ≥24 wk of follow-up (n=82) was 8.2 mo (range, 5.5-10.5). Of 147 treated pts, 87 (59.2%), 26 (17.7%), and 19 (12.9%) had papillary, chromophobe, and unclassified histology, respectively 15 pts had translocation (4.1%), medullary (0.7%), or other (5.4%) histology. Efficacy was evaluated in treated pts who had the opportunity for ≥24 wk of follow-up. Primary end point was confirmed ORR (CR + PR) per RECIST v1.1 by BICR secondary end points were DOR, DCR (CR + PR + SD), PFS, OS, and safety. MethodsĪdults with previously untreated advanced nccRCC and measurable disease per RECIST v1.1 received pembro 400 mg IV Q6W up to 18 cycles (∼2 y) + lenva 20 mg orally QD. We report the first results of KEYNOTE-B61, a single-arm, phase 2 study (NCT04704219) evaluating pembro + lenva as first-line treatment for nccRCC. In nccRCC, first-line pembro monotherapy showed promising antitumor activity in cohort B of the phase 2 KEYNOTE-427 study. In ccRCC, first-line pembro + lenva improved OS, PFS, and ORR vs sunitinib in the phase 3 KEYNOTE-581 study. 18 Medicine, Memorial Sloan Kettering Cancer Center, 10065 - New York/US.17 Medical Oncology, Merck & Co., Inc., 07065 - Rahway/US.16 Medical Oncology, University of Newcastle, 2298 - Callaghan/AU.15 Surgery, Centre de Recherche du CHU de Québec, G1R 2J6 - Quebec/CA.14 Medicine-oncology, Ege University Medical Faculty, 35100 - Izmir/TR.13 Medical Oncology, Oncology Center-Institute Marii Sklodowskiej-Curie, 02-743 - Warsaw/PL.12 Medical Oncology, Fiona Stanley Hospital, 6150 - Perth/AU.11 Urology, Dnipro State Medical University, 49005 - Dnipro/UA. ![]() 10 Oncourology, Regional Cancer Center, 61070 - Kharkiv/UA.9 Oncology, Asan Medical Center, University of Ulsan College of Medicine, 5505 - Seoul/KR.8 Medical Oncology, Institut de Cancérologie Strasbourg Europe, 67033 - Strasbourg/FR.7 Chemotherapy, Poznan University of Medical Sciences, 60-569 - Poznan/PL.6 School Of Clinical Sciences, Monash University, 3168 - Melbourne/AU. ![]()
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