Abstract 695P
Background
ProNiHN is a prospective, observational and multicenter study of pts with R/M SCCHN treated by nivo after progressing on or after platinum-based therapy. The prior report showed consistent outcomes as compared with the pivotal clinical trials. We report here follow-up (FU) outcomes and QoL data.
Methods
interim analysis of data from 454 pts who have a minimum FU of 6 months (mo). Overall survival (OS) and progression-free survival (PFS) were estimated using Kaplan-Meier method, QoL of pts was measured with Functional Assessment of Cancer Therapy Head & Neck (FACT-H&N) and EQ-5D visual analytic scale (VAS).
Results
Median FU was 20.7 mo (range 5.9 – 32.5). 81.3% of pts were male, median age was 64.3 years (y) and 28% were aged ≥70 y at inclusion. ECOG PS was 0-1 in 71.8%, ≥2 in 19.6% and unknown in 8.6% pts. Principal primary tumor locations were oropharynx (33.5%), oral cavity (28.4%), hypopharynx (14.5%) and larynx (12.3%). Nivo was given 1st line (1L) in 10.8%, 2L in 67%, ≥ 3L in 22.2%. Median OS (mOS) was 9.1 mo (95% CI 7.9 – 10.1) and mPFS 3.2 mo (95% CI 2.9 - 3.7). mOS was consistent in subgroups based on age, line of therapy and HPV status but was longer in pts with ECOG PS 0-1 vs ECOG PS ≥2 (9.2 vs 4.0 mo, p<0.0001) and in metastasis vs locoregional recurrence (p= 0.0012). Overall median duration of treatment was 3.4 mo (95% CI 3.3 – 3.7). Of 390 pts who stopped nivo, 208 (53.3%) received systemic therapy, mOS was 7.2 mo and mPFS 4.4 mo. Treatment-related AEs (TRAEs) occurred in 101 (20.4%), 19 pts presented grade 3/4, 6 pts experienced TRAEs with fatal outcomes including acute respiratory failure (1), general health alteration (1), acute renal failure and hypercalcemia (1), sepsis (1), disease progression (1) and lack of efficacy (1). QoL has been compared for 111 pts between inclusion and mo 6; a majority reported stability/improvement (FACT-H&N total score: 28.6%/23.8%; EQ-5D-VAS: 35.4%/35.4%).
Conclusions
Real-world data from ProNiHN shows that nivo is effective in a broad patient population. The safety data collected is consistent with the known safety profile. Half of pts received systemic therapy post nivo. The PRO/QoL remained stable under therapy.
Clinical trial identification
NCT04050761.
Editorial acknowledgement
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
C. Le Tourneau: Non-Financial Interests, Personal, Other, during the conduct of the study: Bristol Myers Squibb; Financial Interests, Personal, Other, outside the submitted work: MSD, AstraZeneca, Merck Serono, Nanobiotix, Seattle Genetics, GSK, Celgene, Rakuten, Roche. S. Salas: Financial Interests, Personal, Other: Bristol Myers Squibb, Merck. Y. Pointreau: Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Other, Consulting: Bristol Myers Squibb. V. Rondeau: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Pfizer, GSK, Fresenius Kabi, Innothera, Boiron. J. Guigay: Financial Interests, Personal, Advisory Board: BMS, Merck Serono, Roche, Hookipa, Nanobiotix; Financial Interests, Personal, Invited Speaker: Merck SD; Financial Interests, Institutional, Invited Speaker: Merck, BMS. C. Toullec: Financial Interests, Personal, Other, Consulting fees: Merck-Serono; Financial Interests, Personal, Invited Speaker, Honoraria for lectures/presentations/speakers bureaus: Amgen, Merck Serono, Bristol Myers Squibb; Financial Interests, Personal, Other, Support for attending meetings and/or travel: MSD, Merck-Serono, Bristol Myers Squibb. A. Theron: Financial Interests, Personal, Principal Investigator: Bristol Myers Squibb; Financial Interests, Personal, Other, Congress invitation: Janssen. A. Houessinon: Financial Interests, Personal, Other, Honoraria for lectures, presentations, speakers bureaus, educational events: Bristol Myers Squibb; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Merck. F. Cotté: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. M. Lavignon: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. C. Even: Financial Interests, Personal, Advisory Board: BMS, MSD, Innate Pharma, Merck Serono; Financial Interests, Institutional, Advisory Board: F Star Therapeutics; Financial Interests, Institutional, Invited Speaker: BMS, AstraZeneca, ISA Pharmaceutics, MSD, Debiopharma, Ayala, Novartis. J. Fayette: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Merck Serono, Innate Pharma, Roche; Financial Interests, Personal, Advisory Board: AstraZeneca. All other authors have declared no conflicts of interest.