Topnivo - A Safety Study Of Nivolumab In Patients With Recurrent And/Or Metastatic Platinum-Refractory Squamous Cell Carcinoma Of Head And Neck (R/M Scchn): Final Analysis

In the randomized phase III Study CA209141, Nivolumab (N) demonstrated significant overall survival (OS) benefit with favorable safety profile for platinum refractory R/M SCCHN and is now approved for these patients (pts). The objectives of the current study were to provide additional insights into the frequency of high-grade adverse events (AEs) related to N and the efficacy of N in real life. From 08/2017 to 11/2018, 343 pts were treated in the multicenter phase II TOPNIVO. The main inclusion criteria were pts with platinum refractory R/M SCCHN, ECOG 0-2. Pts received N 3mg/kg every 2 weeks intravenously. We report safety and efficacy (OS, progression free survival (PFS), overall response rate (ORR)). Median age was 62 yr (73 pts ≥ 70 yr), 81% male, 85% ECOG 0-1, 15% ECOG 2. Cancer primary site was oropharynx 40%, oral cavity 24%, hypopharynx 20%, larynx 15%. 37% had loco regional (LR) relapse, 30% metastatic disease and 33% both. 51% had received one prior line of chemotherapy and 27% two prior lines before inclusion. Median number of N administrations was 6 (from 1 to 63). 233 pts (68%) experienced ≥ 1 AE grade ≥3. On the 434 AEs grade 3-4, 53 (mainly pneumopathy, lipase increase, endocrine disorders and asthenia) were related to N and occurred in 36 pts (10%). On the 89 AEs grade 5, 5 were considered related to N (3 pneumonitis, 1 hepatitis, 1 cardiac arrest). Median follow-up was 23.5 months (mo). 268 pts died. OS, PFS and ORR are reported in the table. Sex, ECOG, type of relapse and number of prior lines were significantly associated with OS in multivariate analysis. Sex and type of relapse were significantly associated with PFS and ORR in multivariate analysis.Table: 917MOMedian OS (mo) [95%CI]Median PFS (mo) [95%CI]ORR n (%)All pts7.5 [6.5; 8.9]1.8 [1.8; 1.9]56 (16)Male7.1 [5.9; 8,3]1.8 [1.8; 1.9]41 (15)Female12.7 [7.3; 14,6]2.2 [1.7; 4.0]15 (23)<70 yr7.5 [6.0; 8.9]1.8 [1.8; 1.9]39 (14)≥70 yr7.9 [6.0; 13.5]2.4 [1.8; 3.6]17 (23)ECOG 014.8 [8.9; 18,8]2.9 [1.8; 4.0]16 (19)ECOG 17.3 [5.6; 9,3]1.8 [1.8; 2.0]34 (17)ECOG 23.1 [1.6; 5.5]1.7 [1.3; 1.8]6 (12)LR relapse7.3 [5.4; 9.0]1.8 [1.7; 2.0]16 (13)Metastatic relapse14.6 [8.3; 19.4]2.8 [1.9; 3.6]26 (25)Both4.7 [4.0; 7.1]1.8 [1.7; 1.9]14 (12)No prior systemic treatment4.5 [1.6; 12.7]1.8 [1.1; 2.9]5 (19)1 prior line9.3 [7.1; 11.5]1.8 [1.8; 2.2]32 (18)≥2 prior lines6.6 [4.9; 8.4]1.9 [1.8; 2.0]19 (13) Open table in a new tab The final analysis of the TOPNIVO study shows no additional toxicities of N compared to what has been described previously, confirms the previous results in terms of efficacy with new data for prognostic factors.