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Nivolumab plus low-dose ipilimumab as first-line treatment of advanced NSCLC: Overall survival analysis of checkmate 817

Date

12 Dec 2019

Session

Mini Oral session 1

Presenters

Fabrice Barlesi

Citation

Annals of Oncology (2019) 30 (suppl_11): xi33-xi47. 10.1093/annonc/mdz451

Authors

F. Barlesi1, C. Audigier-Valette2, E. Felip3, T. Ciuleanu4, K. Jao5, E. Rijavec6, L. Urban7, J. Aucoin8, C. Zannori9, K. Vermaelen10, O. Arén Frontera11, N. Ready12, A. Curioni13, H. Linardou14, E. Poddubskaya15, J.R. Fischer16, R. Pillai17, S. Li18, A. Acevedo19, L. Paz-Ares20

Author affiliations

  • 1 Multidisciplinary Oncology And Therapeutic Innovations, Aix-Marseille Université; CNRS, INSERM, CRCM; Assistance Publique-Hôpitaux de Marseille (APHM), 13005 - Marseille/FR
  • 2 Pulmonology Department, Hôpital Sainte-Musse, 83056 - Toulon/FR
  • 3 Medical Oncology Department, Vall d’Hebron University Hospital, 8035 - Barcelona/ES
  • 4 Medical Oncology Department, The Oncology Institute Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, RO-400015 - Cluj-Napoca/RO
  • 5 Department Of Hematology And Oncology, Hôpital du Sacré-Cœur de Montréal, H4J 1C5 - Montreal/CA
  • 6 Lung Cancer Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale Policlinico San Martino, 16132 - Genova/IT
  • 7 Department Of Thoracic Malignancies, Matrahaza University and Teaching Hospital, 3233 - Matrahaza/HU
  • 8 Hematology And Oncology, Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-Centre-du-Québec, G8Z 3R9 - Trois-Rivières/CA
  • 9 Uoc Oncologia, Azienda Ospedaliera Santa Maria di Terni, 05100 - Terni/IT
  • 10 Pulmonary Medicine, Ghent University Hospital, 9000 - Ghent/BE
  • 11 Department Of Medical Oncology, Centro Internacional de Estudios Clinicos, 8420383 - Santiago/CL
  • 12 Medical Oncology, Duke Cancer Center, 22710 - Durham/US
  • 13 Department Of Medical Oncology And Hematology, University Hospital Zurich, 8091 - Zurich/CH
  • 14 Oncology Unit, Metropolitan Hospital, 18547 - Athens/GR
  • 15 Oncological Department, VitaMed LLC, 121309 - Moscow/RU
  • 16 Department Of Internal Medicine And Oncology, Löwenstein Clinic gGmbH, 74245 - Löwenstein/DE
  • 17 Department Of Hematology And Oncology, Winship Cancer Institute, Emory University, 30322 - Atlanta/US
  • 18 Gbs Biostatistics/global Biometric Sciences Team, Bristol-Myers Squibb, 08540 - Princeton/US
  • 19 Clinical Development/clinical Trial Lead - Metastatic Nsclc Program, Bristol-Myers Squibb, 08540 - Princeton/US
  • 20 Medical Oncology Department, Hospital Universitario 12 de Octubre, 28041 - Madrid/ES
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Resources

Background

Nivolumab (NIVO) + ipilimumab (IPI) combination demonstrated improved overall survival (OS) benefits vs chemotherapy as first-line treatment for advanced NSCLC in both tumor programmed death ligand 1 (PD-L1) expression ≥ 1% and < 1% in CheckMate 227. CheckMate 817 is a multi-cohort, single arm, phase IIIb study evaluating the safety of flat-dose NIVO + weight-based low-dose IPI in advanced NSCLC. Preliminary safety and efficacy results were previously reported for cohorts A and A1. Here we present additional safety data and OS in these cohorts.

Methods

Patients with previously untreated stage IV or recurrent NSCLC, and no known sensitizing EGFR or ALK alterations, were eligible regardless of PD-L1 expression. Cohort A (n = 391) had ECOG performance status (PS) 0–1; cohort A1 (special populations; n = 198) had ECOG PS 2 or a specified comorbidity (asymptomatic untreated brain metastases, hepatic or renal impairment, or HIV). Patients were treated with NIVO 240 mg Q2W + low-dose IPI 1 mg/kg Q6W for 2 years or until disease progression/unacceptable toxicity. Safety in cohort A was the primary endpoint; efficacy endpoints were secondary/exploratory; A1 safety and efficacy analyses were exploratory.

Results

Baseline characteristics apart from ECOG PS and comorbidities were similar between cohorts. With minimum follow-up of 21 months (A) and 14 months (A1), median OS was 17.0 months and 9.9 months, respectively. At 1 year, 60% of patients in A and 47% of patients in A1 were alive. OS by PD-L1 expression and tumor mutational burden levels will be presented. The safety profile (type and rate of treatment-related adverse events [TRAEs]) was consistent between the cohorts. The range of median time to onset of select TRAEs was similar between cohorts A (2–26 weeks) and A1 (2–21 weeks). The majority of select TRAEs have resolved (40%–100%).

Conclusion

Select TRAE profile of NIVO + low-dose IPI was similar between cohorts A and A1. Durable OS outcomes were observed with first-line NIVO+IPI in patients with advanced NSCLC (cohort A) and were comparable to CheckMate 227; although as expected, comorbidities and/or poor performance status impacted outcomes in cohort A1.

Clinical trial identification

NCT02869789.

Editorial acknowledgement

Writing and editorial assistance was provided by Mhairi Laird, PhD, of Caudex and funded by Bristol-Myers Squibb.

Legal entity responsible for the study

Bristol-Myers Squibb.

Funding

Bristol-Myers Squibb.

Disclosure

F. Barlesi: Honoraria (self): AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Novartis, Merck, MSD, Pierre Fabre, Pfizer, Takeda; Advisory / Consultancy: AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Novartis, Merck, MSD, Pierre Fabre, Pfizer, Takeda; Research grant / Funding (institution): AbbVie, ACEA, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Eisai, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Genentech, Ipsen, Ignyta, Innate Pharma, Loxo, Novartis, Medimmune, Merck, MSD, Pierre Fabre, Pfizer, Sanofi-Aventis,; Non-remunerated activity/ies: Principal Investigator for AstraZeneca, Bristol-Myers Squibb, Merck, Pierre Fabre and Roche sponsored trials (or ISR). C. Audigier-Valette: Honoraria (self): AbbVie, Pfizer; Honoraria (institution): Roche, MSD, Bristol-Myers Squibb, AstraZeneca; Advisory / Consultancy: Roche, MSD, Bristol-Myers Squibb, AstraZeneca, AbbVie, Pfizer. E. Felip: Advisory / Consultancy: AbbVie, AstraZeneca, Blue Print Medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Guardant Health, Janssen, Medscape, Merck KGaA, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, TouchTime; Speaker Bureau / Expert testimony: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck KGaA, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda. T-E. Ciuleanu: Advisory / Consultancy: Astellas, Janssen, Bristol-Myers Squibb, Merck Serono, Amgen, Roche, Pfizer, Boehringer Ingelheim, Lilly, AstraZeneca, MSD, Sanofi, Novartis, Servier, AD Pharma. K. Jao: Advisory / Consultancy: AbbVie, AstraZeneca, Bayer, Bristol-Myers Squibb, Pfizer, Merck, Takeda, Roche; Speaker Bureau / Expert testimony: AstraZeneca/CIOSK. J-S. Aucoin: Advisory / Consultancy: AstraZeneca, Bristol-Myers Squibb, Merck, Novartis, Pfizer, Roche; Speaker Bureau / Expert testimony: AstraZeneca, Merck, Pfizer, Roche. K. Vermaelen: Honoraria (self): MSD, Roche; Honoraria (institution): Bristol-Myers Squibb; Advisory / Consultancy: MSD, Bristol-Myers Squibb, Roche; Research grant / Funding (institution): Bristol-Myers Squibb. O. Arén Frontera: Full / Part-time employment: Pfizer. N. Ready: Honoraria (self): Bristol-Myers Squibb, AstraZeneca, G1 therapeutics, Merck, Genentech, AbbVie, Bristol-Myers Squibb – unbranded speaker, Celgene – unbranded speaker; Advisory / Consultancy: Bristol-Myers Squibb, AstraZeneca, G1 therapeutics, Merck, Genentech, AbbVie; Speaker Bureau / Expert testimony: Bristol-Myers Squibb – unbranded speaker, Celgene – unbranded speaker; Research grant / Funding (self): Merck investigator-initiated trial. A. Curioni: Advisory / Consultancy: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, MSD, Roche, Pfizer, Takeda. H. Linardou: Advisory / Consultancy: Bristol-Myers Squibb, MSD, AstraZeneca, Roche; Speaker Bureau / Expert testimony: AstraZeneca. R. Pillai: Research grant / Funding (self): Bristol-Myers Squibb. S. Li: Full / Part-time employment: Bristol-Myers Squibb. A. Acevedo: Shareholder / Stockholder / Stock options: Bristol-Myers Squibb; Full / Part-time employment: Bristol-Myers Squibb. L. Paz-Ares: Honoraria (self): Roche, MSD, Lilly, Novartis, Boehringer Ingelheim, AstraZeneca, Amgen, Sanofi, Pharmamar, Pfizer, Bristol-Myers Squibb, Merck, Takeda, Celgene, Servier, Sysmex, Incyte, Ipsen, Adacap, Bayer, Blueprint; Leadership role: Altum Sequencing; Research grant / Funding (institution): MSD, AstraZeneca, Pfizer, Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

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