Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915)
Jeffrey S Weber, Dirk Schadendorf, Michele Del Vecchio, James Larkin, Victoria Atkinson, Michael Schenker, Jacopo Pigozzo, Helen Gogas, Stéphane Dalle, Nicolas Meyer, Paolo A Ascierto, Shahneen Sandhu, Thomas Eigentler, Ralf Gutzmer, Jessica C Hassel, Caroline Robert, Matteo S Carlino, Anna Maria Di Giacomo, Marcus O Butler, Eva Muñoz-Couselo, Michael P Brown, Piotr Rutkowski, Andrew Haydon, Jean-Jacques Grob, Jacob Schachter, Paola Queirolo, Luis de la Cruz-Merino, Andre van der Westhuizen, Alexander M Menzies, Sandra Re, Tuba Bas, Veerle de Pril, Julia Braverman, Daniel J Tenney, Hao Tang, Georgina V Long, Jeffrey S Weber, Dirk Schadendorf, Michele Del Vecchio, James Larkin, Victoria Atkinson, Michael Schenker, Jacopo Pigozzo, Helen Gogas, Stéphane Dalle, Nicolas Meyer, Paolo A Ascierto, Shahneen Sandhu, Thomas Eigentler, Ralf Gutzmer, Jessica C Hassel, Caroline Robert, Matteo S Carlino, Anna Maria Di Giacomo, Marcus O Butler, Eva Muñoz-Couselo, Michael P Brown, Piotr Rutkowski, Andrew Haydon, Jean-Jacques Grob, Jacob Schachter, Paola Queirolo, Luis de la Cruz-Merino, Andre van der Westhuizen, Alexander M Menzies, Sandra Re, Tuba Bas, Veerle de Pril, Julia Braverman, Daniel J Tenney, Hao Tang, Georgina V Long
Abstract
Purpose: Ipilimumab and nivolumab have each shown treatment benefit for high-risk resected melanoma. The phase III CheckMate 915 trial evaluated adjuvant nivolumab plus ipilimumab versus nivolumab alone in patients with resected stage IIIB-D or IV melanoma.
Patients and methods: In this randomized, double-blind, phase III trial, 1,833 patients received nivolumab 240 mg once every 2 weeks plus ipilimumab 1 mg/kg once every 6 weeks (916 patients) or nivolumab 480 mg once every 4 weeks (917 patients) for ≤ 1 year. After random assignment, patients were stratified by tumor programmed death ligand 1 (PD-L1) expression and stage. Dual primary end points were recurrence-free survival (RFS) in randomly assigned patients and in the tumor PD-L1 expression-level < 1% subgroup.
Results: At a minimum follow-up of approximately 23.7 months, there was no significant difference between treatment groups for RFS in the all-randomly assigned patient population (hazard ratio, 0.92; 95% CI, 0.77 to 1.09; P = .269) or in patients with PD-L1 expression < 1% (hazard ratio, 0.91; 95% CI, 0.73 to 1.14). In all patients, 24-month RFS rates were 64.6% (combination) and 63.2% (nivolumab). Treatment-related grade 3 or 4 adverse events were reported in 32.6% of patients in the combination group and 12.8% in the nivolumab group. Treatment-related deaths were reported in 0.4% of patients in the combination group and in no nivolumab-treated patients.
Conclusion: Nivolumab 240 mg once every 2 weeks plus ipilimumab 1 mg/kg once every 6 weeks did not improve RFS versus nivolumab 480 mg once every 4 weeks in patients with stage IIIB-D or stage IV melanoma. Nivolumab showed efficacy consistent with previous adjuvant studies in a population resembling current practice using American Joint Committee on Cancer eighth edition, reaffirming nivolumab as a standard of care for melanoma adjuvant treatment.
Trial registration: ClinicalTrials.gov NCT03068455.
Conflict of interest statement
Jeffrey S. Weber
Stock and Other Ownership Interests: Biond, OncoC4, Instil Bio, Evaxion Biotech, Nexlmmune
Honoraria: Bristol Myers Squibb, Merck, Genentech, AstraZeneca, Daiichi Sankyo, GlaxoSmithKline, Amgen, Roche, Celldex, CytomX Therapeutics, Novartis, Sellas Life Sciences, WindMIL, Takeda, Moderna Therapeutics, Jounce Therapeutics, Kirin Pharmaceuticals, Regeneron, Idera, Oncosec, Incyte, Nexlmmune, Instil Bio, Ultimovacs, OncoC4, Biond Biologics, Pfizer
Consulting or Advisory Role: Celldex, Bristol Myers Squibb, Merck, Genentech, Roche, Amgen, AstraZeneca, GlaxoSmithKline, Daiichi Sankyo Recipient, CytomX Therapeutics Recipient, Novartis, Sellas Life Sciences, WindMIL Recipient, Jounce Therapeutics Recipient, Moderna Therapeutics, Kirin Pharmaceuticals Recipient, Protean Biodiagnostics, Idera, Oncosec, OncoC4, Incyte, Instil Bio, Biond Biologics, Ultimovacs Recipient, Pfizer, Nexlmmune
Research Funding: Bristol Myers Squibb (Inst), Merck (Inst), GlaxoSmithKline (Inst), Genentech (Inst), Astellas Pharma (Inst), Incyte (Inst), Roche (Inst), Novartis (Inst), NextCure (Inst), Moderna Therapeutics (Inst)
Patents, Royalties, Other Intellectual Property: Named on a patent submitted by Moffitt Cancer Center for an IPILIMUMAB biomarker, named on a patent from Biodesix for a PD-1 antibody biomarker, named on a patent for 41BB induced TIL by Moffitt Cancer Center
Travel, Accommodations, Expenses: Bristol Myers Squibb, GlaxoSmithKline, Roche, Celldex, Amgen, Merck, AstraZeneca, Genentech, Novartis, Merck Sharp & Dohme
Michele Del Vecchio
Consulting or Advisory Role: Novartis, Bristol Myers Squibb, Merck, Pierre Fabre
James Larkin
Honoraria: Bristol Myers Squibb, Pfizer, Novartis, Incyte, Merck Serono, Eisai, touchlME, touchEXPERTS, Royal College of Physicians, Cambridge Healthcare research, RCGP, VJOncology, Agence Unik
Consulting or Advisory Role: Bristol Myers Squibb, Incyte, iOnctura, Apple Tree Partners, Merck Serono, Eisai, Debiopharm Group, Pierre Fabre, Ipsen, Roche, EUSA Pharma, Novartis, Aptitude Health, AstraZeneca, GlaxoSmithKline, Calithera Biosciences, Ultimovacs, Seattle Genetics, eCancer, Insel Gruppe, Pfizer, Goldman Sachs, MSD Oncology, Agence Unik
Research Funding: Pfizer (Inst), Novartis (Inst), MSD Recipient (Inst), Bristol Myers Squibb (Inst), Achilles Therapeutics (Inst), Roche (Inst), Nektar (Inst), Covance (Inst), Immunocore (Inst), AVEO (Inst), Pharmacyclics (Inst)
Travel, Accommodations, Expenses: Roche/Genentech, GlaxoSmithKline, Pierre Fabre
Victoria Atkinson
Honoraria: Bristol Myers Squibb, Novartis, Merck Sharp & Dohme, Fabre, Roche/Genentech, Merck Serono, Nektar, QBiotics, Provectus Biopharmaceuticals
Consulting or Advisory Role: Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Merck Serono, Pierre Fabre, Roche, QBiotics
Speakers' Bureau: Roche/Genentech, Bristol Myers Squibb, Novartis, Merck Sharp & Dohme, Merck Serono
Expert Testimony: Bristol Myers Squibb/Celgene
Travel, Accommodations, Expenses: Bristol Myers Squibb, OncoSec, Derek Sharp & Dohme, Fabre
Michael Schenker
Research Funding: Bristol Myers Squibb, Roche, NISD, Amgen, Pfizer/EMD Serono, Lilly, Astellas Pharma, AstraZeneca, GlaxoSmith Kline, Regeneron, Novartis, AbbVie, Gilead Sciences, Sanofi/Regeneron, Dylan, BIOVEN, Clovis Oncology, Tesaro, Five Prime Therapeutics
Travel, Accommodations, Expenses: Bristol Myers Squibb
Helen Gogas
Honoraria: Bristol Myers Squibb, USD Oncology, Pierre Fabre, Sanofi/Regeneron
Consulting or Advisory Role: Bristol Myers Squibb, USD Oncology, Amgen, Fabre, Sanofi/Regeneron
Research Funding: Bristol Myers Squibb (Inst), Roche (Inst), USD Oncology (Inst), Amgen (Inst), Novartis (Inst), lovance Biotherapeutics (Inst)
Travel, Accommodations, Expenses: Bristol Myers Squibb, USD, Amgen, Pfizer
Stéphane Dalle
Employment: Sanofi Pasteur (I)
Stock and Other Ownership Interests: Sanofi (I)
Consulting or Advisory Role: Bristol Myers Squibb (Inst), N!SD (Inst)
Speakers' Bureau: Bristol Myers Squibb (Inst), N!SD (Inst)
Research Funding: Bristol- Myers Squibb (Inst), Merck Sharp & Dohme (Inst), Roche (Inst)
Travel, Accommodations, Expenses: Bristol Myers Squibb
Nicolas Meyer
Consulting or Advisory Role: Bristol Myers Squibb, USD Oncology, Novartis, Pierre Fabre, Sun Pharma, Nlerckle GmbH
Research Funding: Bristol Myers Squibb (Inst), USD Oncology (Inst)
Paolo A. Ascierto
Stock and Other Ownership Interests: PrimeVax
Consulting or Advisory Role: Bristol Myers Squibb, Roche/Genentech, Merck Sharp & Dohme, Novartis, Array BioPharma, Merck Serono, Pierre Fabre, Incyte, Medlmmune, Astra Zeneca, Sun Pharma, Sanofi, Idera, Ultimovacs, Sandoz, Immunocore, 4SC, AIkermes, Italfarmaco, Nektar, Boehringer Ingelheim, Eisai, Regeneron, Daiichi Sankyo, Pfizer, OncoSec, Nouscom, Ta kis Biotech, Lunaphore Technologies, Seattle Genetics, ITeos Therapeutics, N!edicenna, Bio-AI Health, ValoTx
Research Funding: Bristol Myers Squibb (Inst), Roche/Genentech (Inst), Array BioPharma (Inst), Sanofi (Inst), Pfizer (Inst)
Travel, Accommodations, Expenses: Merck Sharp & Dohme, Pfizer
Shahneen Sandhu
Honoraria: Bristol Myers Squibb (Inst), Derek (Inst), Astra Zeneca (Inst)
Consulting or Advisory Role: Astra Zeneca (Inst), Merck Sharpe & Dohme (Inst), Bristol Myers Squibb/Roche (Inst)
Speakers' Bureau: Bristol Myers Squibb (Inst), Nlerck (Inst), Roche/Genentech, Astra Zeneca (Inst)
Research Funding: Amgen (Inst), Astra Zeneca (Inst), Merck (Inst), Endocyte/Advanced Accelerator Applications (Inst), Genentech/Roche (Inst), Novartis (Inst), Pfizer (Inst), Senhwa Biosciences (Inst), Roche/Genentech (Inst)
Uncompensated Relationships: AAA/Endocyte/Novartis (Inst)
Thomas Eigentler
Honoraria: Bristol Myers Squibb, Novartis
Consulting or Advisory Role: Bristol- Myers Squibb, Novartis, Sanofi, Pierre Fabre
Ralf Gutzmer
Honoraria: Bristol-Myers Squibb, Merck Sharp & Dohme, Roche/Genentech, Novartis, Derek Serono, AImirall Hermal GmbH, Amgen, Sun Pharma, Fabre, Sanofi/Regeneron, Immunocore
Consulting or Advisory Role: Bristol Myers Squibb, Derek Sharp & Dohme, Roche/Genentech, Novartis, AImirall Hermal GmbH, 4SC, Amgen, Fabre, Merck Serono, Sun Pharma, Sanofi, Immunocore
Research Funding: Pfizer (Inst), Novartis (Inst), Johnson & Johnson (Inst), Amgen (Inst), Merck Serono (Inst), Sun Pharma (Inst), Sanofi (Inst)
Travel, Accommodations, Expenses: Bristol Myers Squibb, Roche, Merck Serono, Fabre, Sun Pharma
Jessica C. Hassel
Honoraria: USD, Novartis, Sanofi, AImirall Hermal GmbH, Sun Pharma, Roche Pharma AG, Bristol Myers Squibb Foundation, Kline, Amgen, Fabre
Consulting or Advisory Role: Sun Pharma, Sanofi Aventis GmbH, MSD
Research Funding: Bristol Myers Squibb (Inst), Novartis (Inst), Immunocore (Inst), BioNTech (Inst), 4SC (Inst), Philogen (Inst), Idera (Inst), Genentech/Roche (Inst), lovance Biotherapeutics (Inst), Pierre Fabre (Inst), Regeneron (Inst), Sanofi (Inst), Nektar (Inst), Sun Pharma (Inst)
Caroline Robert
Stock and Other Ownership Interests: RiboNexus
Consulting or Advisory Role: Bristol Myers Squibb, Roche, Novartis, Pierre Fabre, MSD, Sanofi, AstraZeneca, Pfizer
Research Funding: Novartis (Inst), Phio Pharmaeutical (Inst)
Matteo S. Carlino
Honoraria: Bristol Myers Squibb, USD, Novartis
Consulting or Advisory Role: Bristol Myers Squibb, USD, Amgen, Novartis, Fabre, Roche, IDEAYA Biosciences, Sanofi, Merck Serono, Regeneron, QBiotics, OncoSec, Nektar
Anna Maria Di Giacomo
Consulting or Advisory Role: Bristol Myers Squibb, Pierre Fabre, Sanofi, MSD Oncology, GlaxoSmith Kline
Travel, Accommodations, Expenses: Pierre Fabre, Bristol Myers Squibb
Marcus O. Butler
Honoraria: Roche, Merck, Bristol Myers Squibb, Novartis
Consulting or Advisory Role: Merck, Bristol Myers Squibb, Novartis, Immunovaccine, Immunocore, Adaptimmune, EMD Serono, GlaxoSmith Kline, Genzyme, GlaxoSmith Kline, Sanofi, La Roche Posay, Sun Pharma, Instil Bio, lovance Biotherapeutics, Pfizer, Adaptimmune, Medison
Research Funding: Merck, Takara Bio
Expert Testimony: Merck
Eva Muñoz-Couselo
Honoraria: BMS, Novartis, Pierre Fabre, Roche, Sanofi, MSD
Consulting or Advisory Role: Bristol Myers Squibb/Celgene, Novartis, Roche, Pierre Fabre, USD, MSD, Sanofi
Speakers' Bureau: Bristol Myers Squibb/Celgene, Fabre, Sanofi, USD, Novartis
Michael P. Brown
Honoraria: BNS Australia, USD Oncology, Novartis
Consulting or Advisory Role: Bristol Myers Squibb (Inst), Merck Sharp & Dohme (Inst), Novartis (Inst), Cartherics (Inst)
Research Funding: Bristol Myers Squibb (Inst), Merck Sharp & Dohme (Inst), Pharmaust (Inst), Zucero Therapeutics (Inst), CStone Pharmaceuticals (Inst)
Piotr Rutkowski
Honoraria: Bristol Myers Squibb, MSD, Novartis, Roche, Pfizer, Pierre Fabre, Sanofi, Merck
Consulting or Advisory Role: Novartis, Blueprint Medicines, Bristol Myers Squibb, Pierre Fabre, MSD, Amgen
Speakers' Bureau: Pfizer, Novartis, Pierre Fabre
Research Funding: Novartis (Inst), Roche (Inst), Bristol Myers Squibb (Inst)
Travel, Accommodations, Expenses: Orphan Europe, Pierre Fabre
Andrew Haydon
Honoraria: Novartis, Merck, Novartis
Consulting or Advisory Role: Novartis, Merck Sharp & Dohme, Bristol Myers Squibb
Speakers' Bureau: Novartis, Derek, Bristol Myers Squibb
Expert Testimony: BUS
Jean-Jacques Grob
Consulting or Advisory Role: BMS, MSD Oncology, Roche/Genentech, Novartis, Amgen, Pierre Fabre, Merck KGaA, Sun Pharma, Sanofi, Roche, Philogen, Ultmovacs
Speakers' Bureau: Novartis
Travel, Accommodations, Expenses: BMS, USD Oncology, Novartis, Pierre Fabre
Jacob Schachter
Honoraria: Bristol Myers Squibb, MSD
Consulting or Advisory Role: MSD, Bristol Myers Squibb
Travel, Accommodations, Expenses: Bristol Myers Squibb
Paola Queirolo
Consulting or Advisory Role: Roche/Genentech, Novartis, USD, Bristol Myers Squibb, Pierre Fabre, Sanofi, Sun Pharma Advanced Research Company, Merck Serono
Travel, Accommodations, Expenses: MSD Oncology, Sanofi/Regeneron
Luis de la Cruz-Merino
Consulting or Advisory Role: Roche, MSD Oncology, Bristol Myers Squibb, Gilead Sciences, AstraZeneca, Incyte
Research Funding: Roche (Inst), Celgene (Inst)
Travel, Accommodations, Expenses: Roche
Andre van der Westhuizen
Consulting or Advisory Role: MSD Oncology, Novartis
Research Funding: Merck Serono
Travel, Accommodations, Expenses: Bristol Myers Squibb, Roche/Genentech, Novartis
Alexander M. Menzies
Consulting or Advisory Role: USD Oncology, Novartis, Pierre Fabre, Bristol Myers Squibb, Roche, QBiotics
Sandra Re
Stock and Other Ownership Interests: Bristol Myers Squibb
Tuba Bas
Employment: Bristol Myers Squibb, Merck, Fiore Healthcare Advisors (I)
Stock and Other Ownership Interests: Merck Sharp & Dohme, Bristol Myers Squibb (I)
Consulting or Advisory Role: Healthcare Advisors (I)
Travel, Accommodations, Expenses: Merck Sharp & Dohme, Fiore Healthcare Advisors (I)
Veerle de Pril
Employment: Bristol Myers Squibb
Stock and Other Ownership Interests: Bristol Myers Squibb
Julia Braverman
Employment: Bristol Myers Squibb
Stock and Other Ownership Interests: Bristol Myers Squibb
Travel, Accommodations, Expenses: Bristol Myers Squibb
Daniel J. Tenney
Employment: Bristol Myers Squibb Foundation
Stock and Other Ownership Interests: Bristol Myers Squibb Foundation
Travel, Accommodations, Expenses: Bristol Myers Squibb/Celgene
Hao Tang
Employment: Bristol Myers Squibb
Stock and Other Ownership Interests: Bristol Myers Squibb
Georgina V. Long
Honoraria: BMS, Fabre
Consulting or Advisory Role: Agenus, Amgen, Array BioPharma, Boehringer Ingelheim, Bristol Myers Squibb, Evaxion Biotech, Hexal AG (Sandoz Company), Highlight Therapeutics, Innovent USA Inc, Merck Sharp & Dohme, Novartis, OncoSec Medical Australia, PHMR Limited, Pierre Fabre, Provectus, QBiotics, Regeneron
No other potential conflicts of interest were reported.
Figures
FIG 3.
RFS in patient subgroups at…
FIG 3.
RFS in patient subgroups at 24 months with results expressed as unstratified HRs…
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Source: PubMed