1474PNivolumab in non-small cell lung cancer: French evaluation of use, current practices and medico-economic approach

Background: In 2016, nivolumab could be prescribed according to French registration in stage IIIB/IV NSCLC after disease progression with prior platinum-based chemotherapy and TKI therapy for patients with EGFR mutation. The Observatory of Drugs, Medical Devices and Therapeutic Innovations (OMEDIT), a network from the Health Ministry has evaluated the use, current practices and medico-economic approach in the Bretagne and Pays de la Loire areas. Methods: All consenting adult patients with stage IIIB/IV NSCLC who initiated nivolumab (3 mg/kg every 2 weeks) in 2016 were included. Minimum follow-up for survival was 12 months. Sex, age, mutation profile, toxicities, Clinic Benefit (CB: pts with complete/partial response/stable disease as the best response), progression-free survival (PFS) and overall survival (OS) have been studied for ECOG PS 0-1 pts (according to registration). Results: 377 pts with squamous (113 pts), non-squamous (197) and undifferentiated (67) NSCLC have been included. The median number of courses was 8 (1-54). 140 pts (37%) had 1 to 4 courses, 67 pts (18%) 5 to 8 courses and 170 pts (45%) more than 8. 247 pts were treated in 2nd line, 98 in 3rd line. All lines combined, CB was experienced by 212 pts (56%). For these pts, median course was 17 (1-54), mPFS and mOS were 4.6 months and 15.0 months, respectively. No difference on survival has been noticed according to histology, treatment line, age (cut-off 70 y), grade III/IV toxicity. However, mPFS and mOS were lower in ECOG PS ≥ 2 pts than in PS0-1 pts: 2.4 months vs 4.6 m (p < 0.01) for PFS and 3.7 m vs 15.0 m (p < 0.001) for OS. 20% of pts presented grade III/IV toxicities. These pts presented a better CB (74% vs 56%, p = 0.002). In 2016-2017, this treatment, for pts initiated in 2016 only, cost 15.8 million euros (drug, hospitalisation and transportation). 86% of these costs were dedicated to pts who experienced CB. Conclusions: In a real-life setting, survival outcomes and toxicities with nivolumab in advanced NSCLC are comparable to literature data. ECOG PS ≥ 2 pts presented shorter survival than PS0-1 pts. Interestingly, 86% of the cost incurred for these treatments was to pts with CB. Updated data will be shown at the meeting. Legal entity responsible for the study: Cancer Observatory, OMEDIT B and PL. Funding: Has not received any funding. Disclosure: R. Corre: Board, invitation Congress: BMS. J-Y. Douillard: CMO: ESMO. O. Molinier: Expert advice: BMS. All other authors have declared no conflicts of interest.