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

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) 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: 927P

OS outcomes

*Missing data and data with n ≤ 5 were not included. NR, not reached

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.

Clinical trial identification

NCT03114163.

Editorial acknowledgement

Writing and editorial assistance was provided by Vidya Rajagopalan, PhD, of Evidence Scientific Solutions Inc., funded by Bristol Myers Squibb.

Legal entity responsible for the study

Bristol Myers Squibb, Princeton, NJ, USA.

Funding

Bristol Myers Squibb, Princeton, NJ, USA.

Disclosure

E. von der Heyde: Financial Interests, Personal, Full or part-time Employment, Partner: Oncological Practice at Raschplatz; Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor: BMS, Novartis, AstraZeneca, Ipsen, Pierre Fabre, Iomedico; Financial Interests, Institutional, Funding: Novartis, BMS, Boehringer Ingelheim, Ipsen, AstraZeneca. D.A. Hahn: Financial Interests, Personal, Advisory Board, advisory board head and neck cancer, publication of case report nivolumab in head and neck cancer patients: BMS, Merck; Financial Interests, Personal, Advisory Board, advisory board head and neck cancer, invited speaker: MSD; Financial Interests, Personal, Advisory Board, advisory board hodgkin lymphoma, invited speaker: Takeda. H. Mueller-Huesmann: Financial Interests, Institutional, Research Grant: Roche, BMS, Janssen, MSD, Boehringer Ingelheim, Pfizer, Servier, AstraZeneca, Seagen, 420-pharma; Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: Roche, BMS, Janssen, MSD, Pfizer, AstraZeneca, Seagen, 420-pharma; Financial Interests, Personal, Other, Support for attending meetings/Travel: Roche, AstraZeneca; Financial Interests, Personal, Advisory Board: Roche, BMS, AstraZeneca, Seagen. C. Busch: Financial Interests, Personal, Other, Consulting: Bristol Myers Squibb, Merck, MSD, GSK; Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: Bristol Myers Squibb, MSD, MSD, GSK. B.F. Tamaskovics: Financial Interests, Personal, Invited Speaker: Merck Darmstadt, MSD; Financial Interests, Personal, Advisory Board: BMS, Merck Darmstadt, Sanofi, MSD; Financial Interests, Institutional, Invited Speaker: MSD, BMS, AstraZeneca; Non-Financial Interests, Institutional, Product Samples: KLS Martin Group, Tuttlingen, Germany. M.K. Welslau: Financial Interests, Personal, Other, Consulting: BMS, Novartis, Janssen, Amgen, DaiichiSankyo, AstraZeneca; Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: BMS, Novartis, Janssen, Amgen, DaiichiSankyo, AstraZeneca; Financial Interests, Personal, Other, Support for attending meetings/Travel: Janssen, Novartis, Roche; Financial Interests, Personal, Advisory Board: BMS. T.C. Gauler: Financial Interests, Personal, Other, Consulting: BMS, Merck Serono, AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: Merck Serono, AstraZeneca, MSD, Roche; Financial Interests, Personal, Expert Testimony: BMS; Financial Interests, Personal, Other, Support for attending meetings/Travel: Merck Serono; Financial Interests, Personal, Advisory Board, Support for attending meetings/Travel: AstraZeneca, BMS; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Stocks or ownership: Bayer AG. D. Waldenberger: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. A. Dietz: Other, Personal, Leadership Role, Head of the interdisciplinary head and neck working group (IAG-KHT) of the German Cancer Society: interdisciplinary head and neck working group (IAG-KHT) of the German Cancer Society. All other authors have declared no conflicts of interest.