Abstract 1459P
Background
CM 025 demonstrated superior overall survival (OS), and improved safety and tolerability for NIVO in the treatment of previously treated aRCC pts compared with EVE based on 14-months (mos) minimum follow-up. Here, we report results with extended minimum follow-up of 87.7 mos, clinical characteristics of pts with ≥ 7 yrs of OS, and long-term OS and progression-free survival (PFS) predictions based on these data.
Methods
Pre-treated pts with predominantly clear cell aRCC were randomised (1:1) to NIVO 3 mg/kg IV every two weeks or EVE 10 mg orally once daily until progression or unacceptable toxicity. The primary endpoint was OS; secondary endpoints included objective response (ORR), PFS (investigator-assessed using RECIST v1.1), and safety. Additional post-hoc analyses were conducted in pts with OS ≥ 7 yrs. Long-term PFS and OS were predicted by extrapolating observed trial data over a 15-yr horizon and beyond.
Results
With ≥ 7 yrs of follow-up, OS benefit for NIVO (n = 410) vs EVE (n = 411) was maintained (7-yr OS: 18% vs 11%; HR 0.74; 95% CI: 0.63-0.86) and PFS favored NIVO vs EVE (7-yr PFS: 4% vs 0%; HR 0.84; 95% CI: 0.72–0.99). Additional post-hoc analyses in pts with OS ≥ 7 yrs indicated similar baseline characteristics (age, gender, and race) as all-comers. Distributions of favorable, intermediate, and poor risk (per MSKCC criteria) were 50.0%, 39.7%, and 10.3% and 71.4%, 25.7%, and 2.9% for NIVO (n = 58) and EVE (n = 35), respectively. In pts with OS ≥ 7 yrs, NIVO was associated with higher ORR (48% vs 20%), and longer median duration of response (41.9 vs 24.0 mos) and median PFS (15.5 vs 9.5 mos) than EVE. Long-term predictions estimated higher survival rates at 15 yrs in the NIVO arm when compared with the EVE arm.
Conclusions
NIVO continues to demonstrate significant survival benefit vs EVE at ≥ 7 yrs follow-up, which is expected to be sustained over a pts lifetime. Analyses of pts with OS ≥ 7 yrs in the trial further highlight the likelihood of better treatment response and greater lifetime survival benefits observed with NIVO vs EVE.
Clinical trial identification
NCT01668784.
Editorial acknowledgement
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
B. Escudier: Financial Interests, Personal, Advisory Board: Pfizer, Bristol Myers Squibb, Ipsen, Aveo, Eisai. R.J. Motzer: Financial Interests, Personal, Advisory Board: Pfizer, Novartis, Eisai, Exelixis, Merck, Genentech/Roche, Incyte, Lilly Oncology, AstraZeneca, EMD Serono, Aveo Pharmaceuticals, AVEO; Financial Interests, Institutional, Invited Speaker, funding for trial conduct from sponsor to my employer MSKCC: Pfizer, Eisai, Genentech/Roche, Merck, Bristol Myers Squibb, Exelixis, AVEO. M. Dyer: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. J.R. May: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. F. Ejzykowicz: Financial Interests, Personal, Other, BMS employee: BMS; Financial Interests, Personal, Full or part-time Employment, Flavia Ejzykowicz reports being employed by and owning stock in Bristol Myers Squibb: BMS; Financial Interests, Personal, Stocks/Shares: BMS; Financial Interests, Personal, Other, Flavia Ejzykowicz reports being employed by and owning stock in Bristol Myers Squibb: BMS; Non-Financial Interests, Other, reports being employed by and owning stock in Bristol Myers Squibb: BMS; Non-Financial Interests, Personal, Other, Flavia Ejzykowicz reports being employed by and owning stock in Bristol Myers Squibb: BMS. M. Kurt: Financial Interests, Personal, Full or part-time Employment, Employee of Bristol Myers Squibb since June-2018: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares, Owns restricted shares of Bristol Myers Squibb since 2019: Bristol Myers Squibb; Non-Financial Interests, Project Lead: Bristol Myers Squibb. C. Lee: Financial Interests, Personal, Full or part-time Employment, Full time employee of BMS: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. P. Wang: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. E. Testa: Financial Interests, Institutional, Full or part-time Employment, Full time employee of Parexel: Parexel; Financial Interests, Institutional, Research Grant, received research grants/funds from BMS to conduct this research: Bristol Myers Squibb. D.J. Sharpe: Financial Interests, Institutional, Full or part-time Employment, full time employee of Parexel: Parexel; Financial Interests, Institutional, Research Grant, Received research grants/funds from BMS to conduct this research: Bristol Myers Squibb. S. George: Financial Interests, Personal, Advisory Board, advisor/consultant: BMS, Bayer, pfizer, Exelixis, Corvus, Sanofi/ Genzyme, Seattle Genetics, EMD Serono, Eisai, Merck, Aveo, QED therapeutics; Financial Interests, Institutional, Invited Speaker: Pfizer, Merck, Agensys, Novartis, BMS, Bayer, Eisai, Seattle Genetics, Calithera, Corvus, Surface Oncology, Exelixis, Aravive, Aveo, Gilead. N. Tannir: Financial Interests, Personal, Advisory Board, consulting and advisory board: Novartis, Exelixis, Bristol Myers Squibb, Nektar, Pfizer, Eisai, Ono, Onocorena, Surface Oncology, Neoleukin Therapeutics, Ipsen, Merck Sharp & Dohme, Calithera Biosciences, Lilly; Financial Interests, Personal, Other, travel accomodations: Pfizer, Nektar, BMS, Eisai, Surface Oncology, Lilly, Ipsen, Calithera Biosciences; Financial Interests, Personal, Other, Honoraria: Pfizer, Novartis, BMS, Exelixis, Nektar, Eisai, Ono, Lilly, Oncorena, Ipsen, Surface Oncology, Neoleukin Therapeutics, Merkc Sharp & Dohme, Calithera Biosciences; Financial Interests, Institutional, Research Grant: BMS, Exelixis, Pfizer, Nektar, Calithera Biosciences, Lilly, Mirati Therapuetics, Arrowhead Pharmaceuticals, Takeda, Epizyme, Eisai,.