Nivolumab is a standard option for second-line treatment in pts with advanced NSCLC. Real-life data are lacking regarding the efficacy of nivolumab and post-nivolumab treatment.
This analysis included the first 600 consecutive pts with stage IIIB/IV NSCLC who received ≥1 dose of nivolumab 3mg/kg q2w through the French EAP from 01/2015 for Squamous (Sq) and 06/2015 for Non-Sq NSCLC, until 08/2015.
Median age was 64 yo, there were 409 (68%) men, 521 (87%) smokers, 478 (80%) PS0/1 pts, 230 (38%) Sq and 370 (62%) Non-Sq NSCLC, 130 (22%) pts with brain metastases. Nivolumab was administered as 2nd/3rd/≥4th-line for 26%/33%/41% pts, respectively. Best response was PR/SD/PD for 17%/30%/37% of patients, respectively, with 16% not assessable. Toxicities occurred in 187 (31%) pts, including 10% grade ≥3 events. After a median follow-up of 22.1 (95% CI 21.6-22.6) months, median PFS and OS from the initiation of nivolumab were 2.1 (95%CI 1.9-2.3) and 9.5 (95%CI 8.4-10.8) months, respectively. Post-nivolumab treatment was administered to 262 (44%) pts, and mostly consisted of gemcitabine (19%), docetaxel (18%), paclitaxel (14%), erlotinib (12%), vinorelbine (9%), platin-based doublet (8%), or pemetrexed (8%). Access to post-nivolumab treatment was higher in PS0/1 vs. PS2 pts (48% vs. 23%, p
Efficacy and safety of nivolumab was in line with available data. Post-nivolumab treatment may be delivered in many pts, and impact OS. Data on the whole cohort of 900 pts enrolled in the EAP will be presented.
Clinical trial identification
Legal entity responsible for the study
French Cooperative Thoracic Intergroup (IFCT), Paris, France
N. Girard: Received consultancy fees from BMS, MSD, Roche, Astra-Zeneca. C. Audigier Valette: Personal fees and non financial support from Roche, Lilly, Pfizer, Boehringer Ingelheim, Astra Zeneca, Novartis, Amgen and grants from Roche, Boehringer Ingelheim, Novartis. J. Cadranel: Personnal fees from AZ, BMS and Roche for participating to board of experts. I. Monnet: Research funding from BMS, MSD, Astellas and was reimbursed for travel, accommodation, and other expenses by AstraZeneca, Pfizer, Novartis. E. Fabre: Personal fees from BMS, Merck and AstraZeneca. B. Besse: Received research grants from Pfizer, to institution. F. Barlesi: Honorarium from BMS. D. Moro-Sibilot: Personal fees from Roche, Eli Lilly, Pfizer, Novartis, Astra Zeneca, BMS, MSD, Boehringer Ingelheim. O. Molinier: Personal fees from Boehringer and served as expert for Roche, Astra-Zeneca, BMS. All other authors have declared no conflicts of interest.