LAUSR

e21009 Background: In 2016, Nivolumab (N) and Pembrolizumab (P) have been registred for first line ECOG PS 0-1 adult patients with non-resecable or metastatic melanoma. The Brittany and Pays de la Loire Cancer Observatory has collected data on their real-life indications, current management, safety, efficacy and medico-economics Methods: All non opposing adult patients (pts) with advanced cutaneous melanoma who initiated a treatment with N (3 mg/kg q2w) or P (2 mg/kg q3w) in 2016 and 2017 were included. Minimum follow-up for survival was 12 months. Sex, age, mutation profile, lines of treatment, toxicities, response rate, survival and treatment cost have been collected. Results: 149 pts were treated by N and 201 pts by P with a median age of respectively 68 [21-88] and 69 years [28-96]. Of the 350 patients, 34% were at least 75 years and around 30% presented a BRAF mutation. The median duration of treatment was 4.9 months [0-34.6] for N and 4.2 [0-35.8] for P (Not Significant NS). 65% of pts were treated in 1st line for N and 69% for P. 24% of the pts were treated in 2nd line for both treatments. 81% of the pts had a baseline PS of 0 or 1. All lines combined (first line for wt BRAF and first or second line for m BRAF melanoma), clinical benefit was 53% for N and 47% for P. Median OS was respectively 21.7 m for N and 22.8 m for P (NS). mPFS were respectively 6.4 m and 4.6 m (NS). 18% of pts presented grade III/IV toxicities with N and 17% with P. wt BRAF pts showed more grade III/IV toxicities than m BRAF pts (p = 0.046). For N, pts with grade III/IV toxicities showed better PFS (p = 0.051) and OS (p = 0.064). For both cohorts, PS ≥2, BRAF status and treatment line identified subgroup of pts with worsened PFS and OS 55% (24/44) of pts who stopped N or P because of death had a baseline PS of 0-1 showing PS alone is not sufficient to predict survival. Aggressive diseases (high metastasis rate, cerebro-meningeal metastasis, high tumor growth rate with any previous treatment) appear to be the worse candidates for immunotherapy. N and P courses during the 2 years costed 6.6 and 9.7 millions of euros respectively with approximatively 84% or 79% of this cost for N and P clinically benefitting pts. Conclusions: Immunotherapy in real-life setting in cutaneous advanced melanomas confirms literature’s data regarding clinical benefit, survival rate and safety profile and suggests to think about a composite predictive biomarker including BRAF status, ECOG PS, toxicity and treatment line.