927P Patients (pts) with Recurrent And/or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) Treated with Nivolumab (NIVO) in the First-Line (1L) or Later-Line (2L+) Settings in Germany: Updated Results from the Real-World HANNA Study

Real-world data for pts with R/M SCCHN receiving NIVO, particularly in the 1L setting, are limited. Here, we present updated results from the HANNA study (NCT03114163) that collected real-world data from pts with R/M SCCHN initiating NIVO treatment (tx) in the 1L or 2L+ settings in Germany. This multicenter, prospective, non-interventional study included adults with R/M SCCHN progressing on or after platinum (Pt)-based therapy and treated with NIVO according to the approved label, including the 1L population (pts with Pt-sensitive or Pt-refractory disease who progressed > 6 or ≤ 6 months (mo) of Pt-based therapy, respectively). The primary objective was overall survival (OS); secondary objectives included duration of tx (DOT), time to next therapy (TTNT), and safety. This updated analysis (database lock: Jan 16, 2023) included data from May 2017–Jan 2023. Median follow-up was 44.4 mo. Baseline characteristics of the overall population (N = 478) and 1L subset (n = 223) were similar. Median (95% CI) OS was 10.5 (9.0–11.9) mo (overall) and 11.7 (9.5–13.7) mo (1L); median OS was similar in pts with Pt-refractory (11.9 mo [95% CI, 7.9–15.4]) and Pt-sensitive (11.2 mo [8.8–14.9]) disease in the 1L subset. OS by other subgroups is presented (Table). In the 1L subset, 36 (16.1%) pts received subsequent therapy, mainly cetuximab (n = 21; 58.3%). Median DOT was similar in the overall population (5.3 [95% CI, 4.0–5.8] mo) and 1L subset (5.4 [4.0–5.9] mo); median (range) TTNT was 21.0 (2.0–563.0) and 28.0 (3.0–563.0) days, respectively. Overall, any-grade and grade 3/4 tx-related or immune-related adverse events occurred in 156 (32.6%) and 57 (11.9%) pts, respectively.Table: 927POS outcomesOverall population1L subsetnMedian (95% CI) OS, monMedian (95% CI) OS, moOS in all patients47810.5 (9.0–11.9)22311.7 (9.5–13.7)OS by ECOG performance status* 0 1 ≥ 268 215 14619.2 (12.8–35.0) 11.0 (9.5–14.7) 5.3 (4.1–8.8)32 101 7019.2 (11.7–37.1) 12.6 (9.7–17.6) 4.8 (3.0–8.8)OS by primary tumor location* Oropharynx Oral cavity Hypopharynx Larynx Nasopharynx/paranasal sinus181 106 91 70 208.4 (5.6–11.9) 8.0 (5.1–12.2) 8.9 (4.6–11.1) 9.5 (6.6–13.5) 10.9 (4.1–29.8)87 50 39 31 1112.8 (9.2–17.6) 9.1 (5.2–12.1) 9.7 (3.6–17.2) 12.6 (6.6–NR) 15.3 (4.1–NR)*Missing data and data with n ≤ 5 were not included. NR, not reached Open table in a new tab *Missing data and data with n ≤ 5 were not included. NR, not reached Updated results from the real-world HANNA study continue to support NIVO as a safe and effective tx in the 1L or 2L+ settings for pts with R/M SCCHN in Germany.