873P - Nivolumab (NIVO) in the first-line (1L) or second-line (2L) and later (2L+) settings in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Updated results from the German non-interventional study (NIS), HANNA

Background

Real-world data on pts with R/M SCCHN receiving NIVO, particularly in the 1L setting, are needed to assess effectiveness of treatment (tx). Here, we present updated results from the multicenter, prospective, NIS HANNA (NCT03114163) in pts with R/M SCCHN initiating NIVO in the 1L, 2L, and 2L+ settings in Germany.

Methods

Adults with R/M SCCHN progressing on or after platinum (Pt)-based chemo- or chemoradiotherapy were eligible if the decision to initiate NIVO per the approved label was made independent of the study. Subanalyses were also conducted in a subset of pts receiving 1L NIVO, including pts with Pt-sensitive or Pt-refractory disease who progressed > 6 or ≤ 6 months (mo) of Pt-based tx, respectively. The primary objective was overall survival (OS); secondary objectives included time to next tx (TTNT) and safety.

Results

This updated analysis (database lock: Feb 12, 2024) included data from 478 pts overall enrolled between May 2017–July 2021. Median follow-up was 57.2 mo. Baseline characteristics were similar in the overall population and 1L subset (n = 223). Median (95% CI) OS was 10.6 (9.0–11.9) mo (overall), 11.7 (9.5–14.1) mo (1L), and 10.0 (7.8–12.2) mo (2L). In the 1L subset, median OS was similar in pts with Pt-refractory (11.9 mo [95% CI, 7.9–16.4]) and Pt-sensitive (11.7 mo [8.8–14.9]) disease. OS by other subgroups is presented (Table). Median (range) TTNT was 22.0 (2.0–563.0) days (overall) and 31.5 (3.0–563.0) days (1L). In the 1L subset, 38 (17.0%) pts received subsequent tx, mainly cetuximab monotherapy (n = 22; 57.9%). Overall, any-grade and grade 3/4 tx-related or immune-related adverse events were reported in 158 (33.1%) and 58 (12.1%) pts, respectively. Table: 873P

OS by subgroups

Data for primary tumor locations with n < 10 (nasal cavity/pharynx, n = 5; salivary gland, n = 4) are not shown. NR, not reached

Conclusions

Updated results from the NIS HANNA continue to support the use of NIVO as a safe and effective tx in a broad pt population, including pts receiving 1L tx.

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.

Funding

Bristol Myers Squibb.

Disclosure

A. Dietz: Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Advisory Board: MSD. D.A. Hahn: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Other, Member Leitgruppe Kopf Hals Tumore der AIO: Leitgruppe Kopf Hals Tumore der AIO. C. Langer: Financial Interests, Personal, Other, Honoraria: BMS; Financial Interests, Personal, Advisory Board: BMS. B. Kubuschok: Financial Interests, Personal, Other, Payment for patient inclusion and documentation: BMS. H. Mueller-Huesmann: Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Advisory Board: BMS, Janssen, MSD, Boehringer Ingelheim, Pfizer, Servier, AstraZeneca, Seagen, 420-pharma; Financial Interests, Personal, Speaker, Consultant, Advisor: Roche, BMS, Janssen, MSD, Pfizer, AstraZeneca, Seagen, 420-pharma; Financial Interests, Personal, Other, Travel/Meeting attendance: Roche, AstraZeneca. J. von der Grün: Financial Interests, Institutional, Research Grant: Varian (Siemens); Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: Sanofi. C. Busch: Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Personal, Speaker, Consultant, Advisor: BMS, MSD; Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: MSD; Financial Interests, Personal, Other, Travel Support: BMS; Financial Interests, Personal, Other, Support: MSD. B.F. Tamaskovics: Financial Interests, Personal, Invited Speaker: Merck Darmstadt, MSD; Financial Interests, Personal, Advisory Board: BMS, Merck Darmstadt, Sanofi, MSD; Financial Interests, Institutional, Local PI: MSD, BMS, AstraZeneca; Non-Financial Interests, Institutional, Product Samples: KLS Martin Group, Tuttlingen, Germany. T.C. Gauler: Financial Interests, Personal, Speaker, Consultant, Advisor: 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, Travel/Meeting Attendance: Merck Serono, AstraZeneca, BMS; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Stocks or ownership: Bayer. D. Waldenberger: Financial Interests, Personal, Full or part-time Employment: BMS; Financial Interests, Personal, Stocks or ownership: BMS. E. Von der heyde: Financial Interests, Personal, Speaker, Consultant, Advisor, Honoraria: BMS, Novartis, AstraZeneca, Ipsen, Beigene, Iomedico; Financial Interests, Institutional, Research Funding: Novartis, BMS, Boehringer Ingelheim, Ipsen, AstraZeneca. All other authors have declared no conflicts of interest.