The phase III trials CheckMate 017 (NCT01642004) and CheckMate 057 (NCT01673867) demonstrated improved OS with the anti-programmed death (PD)-1 antibody nivo vs doc as treatment (tx) for adv previously treated squamous (SQ) and non-SQ (NSQ) NSCLC, respectively. Approval of nivo in these indications was based on results of these studies. Updated results based on a minimum follow-up (f/u) of 2 y are reported.
Pts received nivo 3 mg/kg Q2W or doc 75 mg/m2 Q3W (1:1 randomization) until progression or discontinuation. The primary objective of each study was OS; additional objectives included investigator-assessed ORR, PFS, efficacy by PD ligand 1 (PD-L1) expression, and safety.
With ≥2 y of f/u, 8% and 9% of pts remained on tx in the nivo groups of CheckMate 017 and 057, respectively, vs 0 pts in either doc group. 2-y OS and PFS rates and ORRs were higher with nivo vs doc in both studies (table). Median duration of response was ≥3 times longer with nivo (25.2 and 17.2 mo) vs doc (8.4 and 5.6 mo), with responses in the nivo groups lasting up to 30.4 and 33.7+ mo (table). Responses were ongoing in 37% and 34% of nivo responders vs 0 doc responders. In CheckMate 057, complete responses (n = 4; 1%) were observed across PD-L1 expression levels (PD-L1 ≥1%: n = 2; PD-L1
With ≥2 y of f/u, nivo continued to demonstrate OS benefit and high rates of durable response vs doc in pts with adv NSCLC. Only nivo-treated pts had tx ongoing and responses lasting >2 y. The safety profile of nivo remained favorable vs doc, with no new safety concerns identified. Updated data on time to onset and resolution of TR select AEs will be presented.
Clinical trial identification
CheckMate 017 = NCT01642004 CheckMate 057 = NCT01673867
Legal entity responsible for the study
F. Barlesi: Honoraria, research funding, and consulting/advisory role with Bristol-Myers Squibb. M. Steins: Honoraria and consulting/advisory role with Bristol-Myers Squibb. L. Horn: Compensated consulting/advisory role for Genentech/Merck as well as uncompensated role with BMS,BI, Xcovery and Bayer. Research funding provided by AZ and the author or family member had a relationship/role/activity/interest with Biodesix. N. Ready: Honoraria from BMS, Celgene, Heat Biologics and travel/accommodations/expenses from AZ. E. Felip: Honoraria and consulting/advisory role with Boeheringer Ingelheim, MSD, Eli Lilly, Roche, Pfizer, Novartis, BMS, Celgene. Speakers Bureau for BMS, Novartis, Roche. H. Borghaei: Honoraria for BMS and Celgene, a consulting/advisory role with BMS, Lilly, Clovis, Genentech and Pfizer. Travel/accommodations/expenses from BMS, Lilly, Genentech and Clovis. D.R. Spigel: Travel/accommodations/expenses from Novartis, Genentech and Pfizer. Speakers'bureau for Novartis (uncompensated) that funded all or part of this research. O. Arrieta: Speakers' Bureau for Pfizer, MSD, AstraZeneca, Novartis, Lilly and Boehringer Ingelheim. Research Funding for AstraZeneca, Novartis, Bristol, Pfizer, MSD. S.J. Antonia: Honoraria, consulting/advisory role and travel/accommodations/expenses from BMS, Merck, AZ and BI. Stock or other ownership from Cellular Biomedicine Group. N. Rizvi: Honoraria from MSD, Amgen, research funding from AZ, consulting/advisory role with MSD, Roche, AZ, BMS, Novartis, Leadership at Gristone Oncology, and Stock or other ownership of Gritstone Oncology. L. Crinò: Speakers' Bureau for BMS, Novartis and AZ. M. Reck: Speakers' Bureau and consulting/advisory role for Roche, Lilly, BMS, MSD, AZ, Pfizer, BI, Celgene. W.E. Eberhardt: Honoraria, consulting/advisory role: BMS, Eli Lilly, AstraZeneca, Pfizer, Roche, Novartis, BI, Merck, Hexal, Bayer, Astellas; consulting/advisory role: Daichi Sankyo; speakers bureau: Roche, Pfizer, Novartis, Merck, BI; research funding: Eli Lilly. M. Hellmann: Research funding from BMS and consulting/advisory roles with BMS, Genentech, Merck, AZ, Inovio, Neon, Axelion. W.J. Geese: Employment from BMS, stock or other ownership from BMS, and travel/accommodations/expenses from BMS. A. Li: Employment, Travel/Accommodations/Expenses and Stock or Other Ownership from BMS. D. Healey: Employment from BMS and stock or other ownership from BMS and Pfizer. J.R. Brahmer: Consulting/Advisory role for Celgene, Lilly, Merck (BMS-uncompensated) and research funding from BMS, MedImmune/AZ, Merck. All other authors have declared no conflicts of interest.