Boris Kubuschok, E. von der Heyde, D.A. Hahn, C. Langer, U. Bockmühl, H. Mueller-Huesmann, G. Klautke, P-S. Mauz, B. Reuter, J. von der Grün, D. Beutner, J. Büntzel, C-J. Busch, B. F. Tamaskovics, J. Riera Knorrenschild, M. K. Welslau, T. C. Gauler, D. Waldenberger, A. Dietz
- Background
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.
Methods
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.
Results
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) andBackground
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.
Methods
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.
Results
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.
Conclusions
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.…
