Effectiveness and quality-of-life (QoL) data from real-world study (ProNiHN) in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of head and neck (R/M SCCHN) treated with nivolumab (nivo) in France

ProNiHN is a prospective, observational and multicenter study of pts with R/M SCCHN treated by nivo after progressing on or after platinum-based therapy. The prior report showed consistent outcomes as compared with the pivotal clinical trials. We report here follow-up (FU) outcomes and QoL data. interim analysis of data from 454 pts who have a minimum FU of 6 months (mo). Overall survival (OS) and progression-free survival (PFS) were estimated using Kaplan-Meier method, QoL of pts was measured with Functional Assessment of Cancer Therapy Head & Neck (FACT-H&N) and EQ-5D visual analytic scale (VAS). Median FU was 20.7 mo (range 5.9 – 32.5). 81.3% of pts were male, median age was 64.3 years (y) and 28% were aged ≥70 y at inclusion. ECOG PS was 0-1 in 71.8%, ≥2 in 19.6% and unknown in 8.6% pts. Principal primary tumor locations were oropharynx (33.5%), oral cavity (28.4%), hypopharynx (14.5%) and larynx (12.3%). Nivo was given 1st line (1L) in 10.8%, 2L in 67%, ≥ 3L in 22.2%. Median OS (mOS) was 9.1 mo (95% CI 7.9 – 10.1) and mPFS 3.2 mo (95% CI 2.9 - 3.7). mOS was consistent in subgroups based on age, line of therapy and HPV status but was longer in pts with ECOG PS 0-1 vs ECOG PS ≥2 (9.2 vs 4.0 mo, p<0.0001) and in metastasis vs locoregional recurrence (p= 0.0012). Overall median duration of treatment was 3.4 mo (95% CI 3.3 – 3.7). Of 390 pts who stopped nivo, 208 (53.3%) received systemic therapy, mOS was 7.2 mo and mPFS 4.4 mo. Treatment-related AEs (TRAEs) occurred in 101 (20.4%), 19 pts presented grade 3/4, 6 pts experienced TRAEs with fatal outcomes including acute respiratory failure (1), general health alteration (1), acute renal failure and hypercalcemia (1), sepsis (1), disease progression (1) and lack of efficacy (1). QoL has been compared for 111 pts between inclusion and mo 6; a majority reported stability/improvement (FACT-H&N total score: 28.6%/23.8%; EQ-5D-VAS: 35.4%/35.4%). Real-world data from ProNiHN shows that nivo is effective in a broad patient population. The safety data collected is consistent with the known safety profile. Half of pts received systemic therapy post nivo. The PRO/QoL remained stable under therapy.