TOPNIVO: A safety study of nivolumab in patients with recurrent and/ or metastatic platinum-refractory squamous cell carcinoma of the head and neck (R/M SCCHN): First results on behalf of the UNICANCER Head&Neck Group and the GORTEC

Background: In the randomized phase III Study CA209141, Nivolumab (N) demonstrated significant overall survival benefit as treatment for platinum refractory R/M SCCHN and is now approved for these patients. N has demonstrated a manageable safety profile compared to chemotherapies commonly used in patients with platinum-refractory R/M SCCHN. Themain objective of the study is to provide additional insight into the frequency of high-grade AEs related to N and their outcome. Methods: Between August 2017 and October 2017, 75 patients were included in the multicenter, open-label, non-controlled phase II safety study TOPNIVO. The main inclusion criteria were patients with platinum refractory R/M SCCHN with progressive disease, ECOG 0-2. Patients received N 3mg/kg every 2 weeks intravenously over 30 minutes. We report here the safety results of the three first months of treatment. Results: Of 73 patients treated with N, median age was 64.0 yr, 75% were male, 23% were ECOG 0, 62% 1, 15% 2, 81% were current or former smoker. The primary site of cancer was oral cavity 27%, oropharynx 34%, larynx 19%, hypopharynx 19%. 36% had loco regional relapse, 34% had metastatic disease and 30% had both. 48% had received one prior line of chemotherapy and 32% two prior lines. 37 pts (51%) received at least 6 administrations of N during the first three months of treatment. 5% of administrations were delayed, mainly for intercurrent disease. 38 pts (52%) ended N within the first three months, 28 pts for progressive disease, 8 due to death (thrombus 1pt, progressive disease or related to cancer 7 pts), 1 for pneumonitis, 1 for pain. 35 pts experienced at least 1 AE grade 3/4/5. On the 52 AEs grade 3-4, 7 (mainly asthenia and lipase increase) were related to N. On the 7 AEs grade 5, 1 (pneumonitis) was related to N. 28 pts (38%) experienced at least 1 SAE. On the 38 SAEs, 3 were related to N. 6 patients experienced tumor bleeding (grade 1 2 pts, grade 2 1 pt, grade 3 1 pt, grade 4 1 pt, grade 5 1 pt), none were related to N. Conclusions: The first results of the TOPNIVO study show an acceptable toxicity profile without additional toxicities compared to what has been described previously.