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ePoster Display

923P - Nivolumab in patients with recurrent and/or metastatic squamous cell carcinoma of head and neck (R/M SCCHN) progressing on/or after a platinum-based therapy: Interim analysis of a prospective French real-world study (ProNiHN)

Date

16 Sep 2021

Session

ePoster Display

Topics

Tumour Site

Head and Neck Cancers

Presenters

Christophe Le Tourneau

Citation

Annals of Oncology (2021) 32 (suppl_5): S786-S817. 10.1016/annonc/annonc704

Authors

C. Le Tourneau1, S. Salas2, Y. Pointreau3, P. Ceruse4, E. Babin5, M. Chehimi6, M. Rotarski7, C. Toullec8, A. Darut Jouve9, A. Najem10, P. Combe11, D. Burlacu12, I. Bourahla13, A. Boin14, V. Rondeau15, C. Even16, J. Fayette17

Author affiliations

  • 1 Department Of Drug Development And Innovation (d3i), Institut Curie, INSERM U900 Research Unit, Paris-Saclay University, 75248 - Paris/FR
  • 2 Department Of Medical Oncology, AP-HM, Marseille/FR
  • 3 Radiotherapy Department, Inter-regionaL Cancer Institute – Jean Bernard Center, Le Mans/FR
  • 4 Department Of Otolaryngology And Head And Neck Surgery, Lyon-Sud University Hospital, 69317 - Lyon/FR
  • 5 Department Of Head And Neck Surgery, Centre Hospitalier Universitaire Caen Normandie, Caen/FR
  • 6 Department Of Oncology, Saint Quentin Hospital, Saint-Quentin/FR
  • 7 Oncology Department, Radiation Oncology Centre, Bayonne/FR
  • 8 Department Of Digestive Oncology, Institut Sainte Catherine, Avignon/FR
  • 9 Medical Oncology Department, 9Center Radiothérapie du Parc, Dijon/FR
  • 10 Medical Oncology Department, CH de Boulogne sur Mer - Hopital Duchenne, 62321 - Boulogne Sur Mer/FR
  • 11 Oncology, Pôle Santé Léonard de Vinci, 37170 - Chambray-lès-Tours/FR
  • 12 Medical Oncology Department, Henri Mondor Hospital Center, 15000 - Aurillac/FR
  • 13 Rco Department, Bristol Myers Squibb, Rueil-Malmaison/FR
  • 14 Medical Oncology Department, Bristol-Myers Squibb, 92500 - Rueil-Malmaison/FR
  • 15 Biostatistics Department, INSERM U1219, ISPED, Bordeaux University, Bordeaux/FR
  • 16 Head And Neck Department, Gustave-Roussy Cancer Campus, 94805 - Villejuif/FR
  • 17 Medical Oncology Department, Léon Bérard Centre, 69008 - Lyon/FR
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Abstract 923P

Background

Based on the survival benefits and favorable safety profile seen in the phase III CheckMate 141 trial,1 nivolumab was approved in Europe in 2017 for patients (pts) with R/M SCCHN who progressed on, or within 6 months (mos) after platinum-based therapy. Data from a large real-world population can provide important insight. ProNiHN was conducted to describe the characteristics of SCCHN pts treated with nivolumab in France and to assess its efficacy and safety.

Methods

This multicenter, observational, longitudinal study included R/M SCCHN pts treated for the first time with nivolumab after progression on platinum-based therapy in France. This first analysis included pts who received ≥1 dose of nivolumab and had ≥6 mos of follow-up. Statistics were descriptive with Kaplan-Meier estimated overall survival (OS) and progression-free survival (PFS).

Results

279 pts from 79 sites were included and followed up for a median of 6.0 mos (range 0.03–18.0). 81.0% were male, median age was 65.0 years (yr) and 31.5% were aged ≥70 yr at nivolumab start. 84.9% were current/former smokers and 21.9% had ECOG PS ≥2. Primary tumor location was larynx (14.0%), hypopharynx (15.1%), oral cavity (28.0%) and oropharynx (33.7%). Median duration of nivolumab was 2.3 mos (range 0.03–18.0). Nivolumab was given 1st line in 11.5%, 2nd line in 66.3%, ≥ 3rd line in 22.2%. Median OS was 8.6 mos (95% CI 6.7–9.7) and PFS 3.1 mos (95% CI 2.8–3.7). Median OS was consistent in subgroups based on age, type of recurrence, line of nivolumab therapy, and time since last platinum therapy, but was longer (9.9 mos) in pts with ECOG PS 0-1 vs ECOG PS ≥2 (3.7 mos). Nivolumab was discontinued in 141 pts (50.5%) due to disease progression (n=127) or study drug-related toxicity (n=6). 81 treatment-related AEs (10 grade 3, 3 grade 4, and 0 grade 5) occurred in 18.6% of pts. Two pts died (disease progression [n=1]; hypercalcemia/renal failure [n=1]).

Conclusions

Preliminary ProNiHN results are consistent with Checkmate 141 for pts with R/M SCCHN treated with nivolumab in real life in France and provide additional information on new subgroups. [1] Ferris RL et al. N Engl J Med. 2016;375:1856-67.

Clinical trial identification

NCT04050761.

Editorial acknowledgement

Medical writing assistance was provided by Tracy Harrison of Springer Healthcare Communications, funded by Bristol Myers Squibb.

Legal entity responsible for the study

Bristol Myers Squibb.

Funding

Bristol Myers Squibb.

Disclosure

C. Le Tourneau: Non-Financial Interests, Personal, Research Grant, outside the submitted work: Bristol Myers Squibb; Non-Financial Interests, Personal, Other, outside the submitted work: MSD; Non-Financial Interests, Personal, Other, outside the submitted work: AstraZeneca; Non-Financial Interests, Personal, Other, outside the submitted work: Merck Serono; Non-Financial Interests, Personal, Other, outside the submitted work: Nanobiotix; Non-Financial Interests, Personal, Other, outside the submitted work: Seattle Genetics; Non-Financial Interests, Personal, Other, outside the submitted work: GSK; Non-Financial Interests, Personal, Other, outside the submitted work: Celgene; Non-Financial Interests, Personal, Other, outside the submitted work: Rakuten; Non-Financial Interests, Personal, Other, outside the submitted work: Roche. S. Salas: Non-Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb. Y. Pointreau: Non-Financial Interests, Personal, Research Grant, outside the submitted work: Bristol Myers Squibb. C. Toullec: Non-Financial Interests, Personal, Other, outside the submitted work: Merck Serono; Non-Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb; Non-Financial Interests, Personal, Other, outside the submitted work: MSD. P. Combe: Non-Financial Interests, Personal, Advisory Board, outside the submitted work: Bristol Myers Squibb; Non-Financial Interests, Personal, Other, outside the submitted work: Bristol Myers Squibb. D. Burlacu: Non-Financial Interests, Personal, Other, outside the submitted work: MSD; Non-Financial Interests, Personal, Other, outside the submitted work: Pfizer; Non-Financial Interests, Personal, Other, outside the submitted work: Pierre Fabre. C. Even: Financial Interests, Personal, Advisory Board, outside the submitted work: Bristol Myers Squibb; Non-Financial Interests, Institutional, Principal Investigator, outside the submitted work: Bristol Myers Squibb; Non-Financial Interests, Personal, Advisory Board, outside the submitted work: Innate Pharma; Non-Financial Interests, Personal, Advisory Board, outside the submitted work: Merck Serono; Non-Financial Interests, Personal, Advisory Board, outside the submitted work: MSD; Non-Financial Interests, Institutional, Principal Investigator, outside the submitted work: AstraZeneca; Non-Financial Interests, Institutional, Principal Investigator, outside the submitted work: Ayala; Non-Financial Interests, Institutional, Principal Investigator, outside the submitted work: Debiopharma; Non-Financial Interests, Institutional, Principal Investigator, outside the submitted work: ISA pharmaceutics; Non-Financial Interests, Personal, Principal Investigator, outside the submitted work: MSD; Non-Financial Interests, Institutional, Principal Investigator, outside the submitted work: Novartis. J. Fayette: Financial Interests, Personal, Advisory Board, outside the submitted work: AstraZeneca; Financial Interests, Personal, Advisory Board, outside the submitted work: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board, outside the submitted work: Innate Pharma; Financial Interests, Personal, Advisory Board, outside the submitted work: Merck Serono; Financial Interests, Personal, Advisory Board, outside the submitted work: MSD; Financial Interests, Institutional, Research Grant, outside the submitted work: Seagens; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca. All other authors have declared no conflicts of interest.

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