Abstract 680P
Background
Real-world data for patients (pts) with R/M SCCHN receiving nivolumab is rare, particularly in the first-line (1L) setting. The multicenter, prospective, non-interventional study HANNA (NCT03114163) in Germany was designed to collect real-world data from pts with R/M SCCHN progressing on or after platinum (Pt)-based therapy and treated according to the label of nivolumab, including 1L population (Pt-sensitive and -refractory).
Methods
The primary objective was overall survival (OS); secondary objectives included duration of treatment (DOT), time to next therapy (TTNT), safety, and health-related quality of life (HRQoL) using Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) and EQ-5D Visual Analog Scale (VAS).
Results
This interim analysis (January 2022) represents data from 477 of 485 pts enrolled between May 2017 and July 2021. Median follow-up was 32.9 months. In all pts, median age was 64 (range: 30-86) years; 81.1% were men, and 74.2% were past/current smokers. Main locations for the primary tumor were oropharynx, 37.7%; oral cavity, 22.2%; hypopharynx, 19.1%; and others/unknown, 21.0%. Baseline characteristics in the 1L subset (n = 222) were similar. Overall, median OS (mOS) was 10.9 months (95% CI: 9.2-12.2). In the 1L subset, mOS was 11.7 months (95% CI: 9.5-13.7), with similar OS benefit in Pt-sensitive and -refractory pts (ie, progressed >6 or ≤6 months of Pt-based therapy, respectively); 61 pts (27.5%) received subsequent therapies. Median DOT was similar in the overall population (5.4 months [95% CI: 4.1–5.8]) and 1L subset (5.7 months [4.1–6.0]). Median TTNT was also comparable in the overall population (9.5 days [range: 1.0-563.0]) and 1L subset (15 days [1.0-563.0]). In the overall population, among the 147 pts (30.8%) experiencing treatment-related or immune-mediated adverse events, events with grade 3/4 severity was noted in 54 pts (11.3%); additionally, HRQoL, measured using FACT-H&N and EQ-5D VAS, remained stable until month 24.
Conclusions
These data indicate that nivolumab is safe and effective with long-term stability in QoL in a broad, real-world population of pts with R/M SCCHN, including the 1L population.
Clinical trial identification
NCT03114163.
Editorial acknowledgement
Writing and editorial assistance was provided by Thai Cao, MS, and Meenakshi Subramanian, PhD, of Evidence Scientific Solutions.
Legal entity responsible for the study
Bristol Myers Squibb, Princeton, NJ, USA.
Funding
Bristol Myers Squibb, Princeton, NJ, USA.
Disclosure
C. Langer: Financial Interests, Personal and Institutional, Invited Speaker: Bristol Myers Squibb, MSD Sharp & Dohme, Merck; Financial Interests, Personal and Institutional, Advisory Board: Bristol Myers Squibb, MSD Sharp & Dohme, Merck, Sanofi. E. von der Heyde: Financial Interests, Institutional, Research Grant: Amgen, Bristol Myers Squibb, Novartis, Ipsen, Lilly, Sanofi; Financial Interests, Personal, Advisory Role, Consulting: Bristol Myers Squibb, Boehringer Ingelheim, Novartis, EUSA Pharm, Merck, MSD, Roche, AstraZeneca; Financial Interests, Personal and Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Personal, Ownership Interest, Partner in this oncology practice: Raschplatz, Hanover. 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, Bristol Myers Squibb, Boehringer Ingelheim, Eisai; Financial Interests, Personal, Other, Honoraria: Roche, Bristol Myers Squibb, Boehringer Ingelheim, AstraZeneca, Seagen; Financial Interests, Personal, Advisory Role, Consulting: Roche, Bristol Myers Squibb, Eisai, AstraZeneca, MSD, Jannssen, Merck, Seagen; Financial Interests, Personal, Other, Travel/Accommodations: Roche, AstraZeneca, Janssen; Financial Interests, Personal, Advisory Role, Consultancy: Boehringer Ingelheim. G. Klautke: Non-Financial Interests, Personal, Invited Speaker: Klinikum Chemnitz; Non-Financial Interests, Personal, Advisory Board: Klinikum Chemnitz. J. Büntzel: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb. C. Busch: Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Speaker’s Bureau: Merck. B.F. Tamaskovics: Financial Interests, Personal, Invited Speaker: Merck Darmstadt; Financial Interests, Personal, Advisory Board: BMS, Merck Darmstadt, Sanofi; Financial Interests, Institutional, Invited Speaker: MSD, BMS, AstraZeneca; Non-Financial Interests, Institutional, Product Samples: KLS Martin Group, Tuttlingen, Germany. T.C. Gauler: Financial Interests, Personal, Stocks/Shares: Bayer; Financial Interests, Personal, Advisory Role, Consulting: Bristol Myers Squibb, AstraZeneca, Merck Serono, Roche, Ipsen; Financial Interests, Personal, Other, Travel/Accommodations: Bristol Myers Squibb, AstraZeneca, Merck Serono, Roche, Ipsen. D. Waldenberger: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. All other authors have declared no conflicts of interest.