5-year survival outcomes of the CheckMate 067 phase III trial of nivolumab plus ipilimumab (NIVO+IPI) combination therapy in advanced melanoma

abstracts

v904 | Melanoma and other skin tumours

LBA68 PR

5-year survival outcomes of the CheckMate 067 phase III trial of nivolumab plus ipilimumab (NIVO1IPI) combination therapy in advanced melanoma

J.M.G. Larkin1, V. Chiarion-Sileni2, R. Gonzalez3, J.J. Grob4, P. Rutkowski5, C. Lao6, C.L. Cowey7, D. Schadendorf8, J. Wagstaff9, R. Dummer10, P.F. Ferrucci11, M. Smylie12, D. Hogg13, A. Hill14, I. Marquez-Rodas15, J.B.A.G. Haanen16, J. Rizzo17, A. Balogh18, F.S. Hodi19, J. Wolchok20 1 Department of Medicine, The Royal Marsden Hospital NHS Foundation Trust, London, UK, 2Head of Melanoma and Esophageal Cancer Unit, Oncology Institute of Veneto IRCCS, Padua, Italy, 3Division of Medical Oncology, University of Colorado Cancer Center, Aurora, CO, USA, 4Oncology, Service de Dermatologie et Cance´rologie Cutane´e, Aix-Marseille University, APHM Timone France, Marseille, France, 5Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland, 6Medical Oncology, Internal Medicine, University of Michigan, Ann Arbor, MI, USA, 7Medical Oncology, Hematology, Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX, USA, 8Department of Dermatology, University of Essen, Essen, Germany; & German Cancer Consortium, Heidelberg, Germany, 9Oncology Department, The College of Medicine, Swansea University, Swansea, UK, 10Dermatology Department, Universit€ ats Spital, Zurich, Switzerland, 11Melanoma Medical Oncology, European Institute of Oncology IRCCS, Milan, Italy, 12Department of Oncology, Cross Cancer Institute, Edmonton, AB, Canada, 13Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON, Canada, 14Department of Medical Oncology, Tasman Oncology Research, Southport, Australia, 15Medical Oncology, General University Hospital Gregorio Maranon, Madrid, Spain, 16Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands, 17 Oncology Clinical Development, Bristol-Myers Squibb, Princeton, NJ, USA, 18Global Biometric Sciences, Bristol-Myers Squibb, Princeton, NJ, USA, 19Melanoma Disease Center, Dana-Farber Cancer Institute, Boston, MA, USA, 20Melanoma & Immunotherapeutics Service, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA Background: Results from CheckMate 067 have shown significant improvements in objective response, progression-free survival (PFS), and overall survival (OS) with NIVOþIPI and NIVO alone vs IPI in patients with advanced treatment-naive melanoma. Here we present 5-year outcomes from the study. Methods: Eligible patients with previously untreated stage III or IV melanoma (N ¼ 945) were randomly assigned 1:1:1 and stratified by programmed death ligand 1 (PD-L1) status, BRAF mutation status, and metastasis stage. Patients received NIVO 1 mg/kg þ IPI 3 mg/kg for 4 doses Q3W followed by NIVO 3 mg/kg Q2W (n ¼ 314), NIVO 3 mg/kg Q2W þ placebo (n ¼ 316), or IPI 3 mg/kg Q3W for 4 doses þ placebo (n ¼ 315) until progression or unacceptable toxicity. Co-primary endpoints were OS and PFS; the study was not powered to compare the NIVO-containing groups. Descriptive analyses were performed to evaluate efficacy between NIVOþIPI and NIVO, treatment-free status, and health-related quality of life (HRQoL). Results: With a minimum follow-up of 60 months, the NIVO-containing arms continued to show improved OS, PFS, and response vs IPI (table). In addition, descriptive analyses showed longer OS with NIVOþIPI (median OS, > 60.0 mo [not reached]) than with NIVO alone (median OS, 36.9 mo), as well as a higher proportion of patients alive and treatment-free with the combination. No sustained deterioration of HRQoL (EQ-5D-3L utility index) was observed during treatment or following treatment discontinuation with NIVO or NIVOþIPI. Conclusions: This 5-year analysis represents the longest phase III follow-up for checkpoint inhibitor combination therapy and demonstrates long-term survival with both NIVO-containing arms vs IPI. In descriptive analyses, NIVOþIPI was associated with improved survival and a higher likelihood of being alive and treatment-free compared with NIVO alone, both without loss of QoL. Clinical trial identification: NCT01844505. Editorial acknowledgement: Writing and editorial assistance was provided by Melissa Kirk, PhD, and Michele Salernitano of StemScientific, an Ashfield Company. Legal entity responsible for the study: Bristol-Myers Squibb. Funding: Bristol-Myers Squibb. Disclosure: J.M.G. Larkin: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Achilles; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Boston Biomedical; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): BMS; Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: EUSA Pharma; Honoraria (self), Advisory / Consultancy: GSK; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy: Imugene; Honoraria (self), Advisory / Consultancy: Incyte; Honoraria (self), Advisory / Consultancy: iOnctura; Honoraria (self), Advisory / Consultancy: Kymab; Honoraria (self), Advisory / Consultancy: Merck Serono; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Nektar; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Novartis; Honoraria (self), Advisory / Consultancy: Pierre Fabre; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Roche; Honoraria (self), Advisory /

Volume 30 | Supplement 5 | October 2019

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Honoraria (institution): Regeneron; Honoraria (self), Honoraria (institution): 4SC; Honoraria (self): AstraZeneca; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): BMS; Honoraria (self), Honoraria (institution): Merck-EMD; Honoraria (self): Pfizer; Honoraria (self), Honoraria (institution): Philogen; Honoraria (self): Array. J.C. Hassel: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Payments to institution for treating patients within clinical trials: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self): Roche; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Sanofi; Advisory / Consultancy: Pierre Fabre. M. Fluck: Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy: Pierre-Fabre. T. Eigentler: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Pierre Fabre; Honoraria (self), Advisory / Consultancy: Sanofi Genzyme; Advisory / Consultancy: Leo Pharma; Honoraria (self), Advisory / Consultancy: MSD. C. Loquai: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre Fabre; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sun Pharma; Advisory / Consultancy, Travel / Accommodation / Expenses: Biontech; Advisory / Consultancy, Travel / Accommodation / Expenses: Almirall; Travel / Accommodation / Expenses: Kyowa Kirin. R. Gutzmer: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses, Non-remunerated activity/ies: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses, Non-remunerated activity/ies: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses, Non-remunerated activity/ies: Merck Serono; Honoraria (self), Advisory / Consultancy, Non-remunerated activity/ies: Amgen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses, Non-remunerated activity/ies: Pierre Fabre; Honoraria (self), Advisory / Consultancy, Non-remunerated activity/ies: Sanofi; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Non-remunerated activity/ies: Novartis; Honoraria (self), Advisory / Consultancy, Non-remunerated activity/ies: Almirall Hermal; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy: Leo; Honoraria (self): AstraZeneca; Honoraria (self), Advisory / Consultancy: SunPharma; Advisory / Consultancy: 4SC; Research grant / Funding (institution): Johnson & Johnson. P. Mohr: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Non-remunerated activity/ies: Pierre Fabre; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Non-remunerated activity/ies: GSK; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Nonremunerated activity/ies: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Non-remunerated activity/ies: Merck; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Non-remunerated activity/ies: Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Non-remunerated activity/ies: BMS; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Non-remunerated activity/ies: Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Non-remunerated activity/ies: Sanofi. A. Hauschild: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy, Research grant / Funding (institution): Merck Serono; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD; Advisory / Consultancy, Research grant / Funding (institution): Philogen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pierre Fabre; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Provectus; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Regeneron; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy: OncoSec; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Sanofi-Genzyme; Advisory / Consultancy: Sun Pharma; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis. J.C. Becker: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Merck Serono; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (institution): Pfizer; Advisory / Consultancy, Travel / Accommodation / Expenses: 4SC; Advisory / Consultancy: CureVac; Advisory / Consultancy: eTheRNA; Advisory / Consultancy: Lytix; Advisory / Consultancy: Novartis; Advisory / Consultancy: ReProTHer; Advisory / Consultancy: Rigontec; Research grant / Funding (institution): Alcedis; Research grant / Funding (institution): BMS; Research grant / Funding (institution): IQVIA; Travel / Accommodation / Expenses: Incyte. F. Kiecker: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Pierre Fabre. C. Garbe: Advisory / Consultancy: Amgen; Advisory / Consultancy: MSD; Advisory / Consultancy, Research grant / Funding (institution): NeraCare; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Philogen; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy, Research grant / Funding (institution): Sanofi. E. Livingstone: Honoraria (self), Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy: Roche; Travel / Accommodation / Expenses: Medac; Honoraria (self): Janssen; Advisory / Consultancy: Actelion; Travel / Accommodation / Expenses: Pierre Fabre. L. Zimmer: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre Fabre; Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis. All other authors have declared no conflicts of interest.

Annals of Oncology

abstracts

Annals of Oncology

Table: LBA68_PR NIVO (n ¼ 316)

IPI (n ¼ 315)

58 (53–64) NRa 11.5 (8.7–19.3) 36 (31–42) NRb (38.2–NR) 52 (46–57) 60 (50–69) 48 (41–54) 51 (44–57) 57 (44–68) NR (59.6–NR)

45 (39–50) NR (50.4–NR) 6.9 (5.1–10.2) 29 (24–35) 36.9 (28.2–58.7) 44 (39–50) 46 (36–56) 43 (37–50) 43 (36–50) 51 (40–62) 25.2 (16.0–43.2)

19 (15–24) 14.4 (8.3–53.6) 2.9 (2.8–3.2) 8 (5–12) 19.9 (16.8–24.6) 26 (22–31) 30 (21–39) 25 (19–31) 24 (18–30) 33 (23–44) 8.0 (6.5–8.7)

112/151 (74)

75/130 (58)

30/67 (45)

NR, not reached. a Although a median was reported at the previous analysis, that estimate was immature and greater than the minimum study follow-up. b > 60.0 mo.

Consultancy: Secarna; Research grant / Funding (self): Aveo; Research grant / Funding (self): Covance; Honoraria (self), Advisory / Consultancy: Vitaccess. V. Chiarion-Sileni: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pierre Fabre; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Merck-Serono; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Incyte. R. Gonzalez: Honoraria (self), Research grant / Funding (self): Bristol-Myers Squibb; Honoraria (self), Research grant / Funding (self): Genentech/Roche; Honoraria (self), Research grant / Funding (self): Novartis; Honoraria (self), Research grant / Funding (self): GSK; Honoraria (self), Research grant / Funding (self): Array; Honoraria (self), Research grant / Funding (self): Amgen; Honoraria (self), Research grant / Funding (self): Incyte; Honoraria (self), Research grant / Funding (self): NewLink Genetics; Research grant / Funding (self): Merck; Research grant / Funding (self): Takeda; Research grant / Funding (self): Boston Biomedical; Research grant / Funding (self): Checkmate Pharmaceuticals; Research grant / Funding (self): Tesaro; Research grant / Funding (self): Syndax; Research grant / Funding (self): Nektar. J.J. Grob: Travel / Accommodation / Expenses: Bristol-Myers Squibb; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: Roche/Genentech; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: AMGEN; Travel / Accommodation / Expenses: Pierre Fabre; Travel / Accommodation / Expenses: Sanofi; Travel / Accommodation / Expenses: Sun Pharma. P. Rutkowski: Honoraria (self), Research grant / Funding (self): Bristol-Myers Squibb; Honoraria (self): MSD; Honoraria (self): Roche; Honoraria (self): Novartis; Honoraria (self): Pierre Fabre; Honoraria (self): Eli Lilly; Honoraria (self): Pfizer; Honoraria (self): Blueprint Medicines . C. Lao: Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Genentech; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Merck; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Dynavax; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Immunocore. D. Schadendorf: Honoraria (self): Roche/Genentech; Honoraria (self): Merck Serono; Honoraria (self): Amgen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Novartis, Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Merck Sharp & Dohme; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Immunocore, Philogen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Incyte, Regeneron; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: 4SC, Mologen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Pierre Fabre; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Mologen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Sanofi/ Regeneron; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Sysmex; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Gru¨nenthal Group; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant /

Volume 30 | Supplement 5 | October 2019

Funding (self), Travel / Accommodation / Expenses: Agenus; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Array; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: BioPharma; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: LEO Pharma. J. Wagstaff: Honoraria (self): Bristol-Myers Squib . R. Dummer: Advisory / Consultancy: Novartis; Advisory / Consultancy: MSD; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Roche; Advisory / Consultancy: Amgen; Advisory / Consultancy: Takeda; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Sun Pharma; Advisory / Consultancy: Sanofi; Honoraria (self): Amgen; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): MSD; Honoraria (self): Novartis; Honoraria (self): Pierre Fabre; Honoraria (self): Roche; Honoraria (self): Sun Pharma; Honoraria (self): Takeda; Honoraria (self): Sanofi. P.F. Ferrucci: Honoraria (self), Research grant / Funding (self): Bristol-Myers Squibb; Honoraria (self): MSD; Honoraria (self): Roche; Honoraria (self): Novartis; Honoraria (self): Pierre Fabre. M. Smylie: Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Merck; Honoraria (self): Sanofi Genzyme; Honoraria (self): Novartis. D. Hogg: Honoraria (self): Bristol-Myers Squibb; Honoraria (self), Research grant / Funding (self): EMD Sereno; Honoraria (self): Novartis; Honoraria (self): Roche; Honoraria (self): Merck. I. Marquez-Rodas: Honoraria (self), Research grant / Funding (self), Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self), Research grant / Funding (self): Novartis; Honoraria (self), Research grant / Funding (self): Roche; Honoraria (self), Research grant / Funding (self): BIONCOTECH; Honoraria (self), Research grant / Funding (self): AMGEN; Honoraria (self), Research grant / Funding (self): Incyte; Honoraria (self): Sanofi ; Honoraria (self): Regeneron. J.B.A.G. Haanen: Research grant / Funding (self): Bristol-Myers Squibb; Research grant / Funding (self): Novartis; Research grant / Funding (self): MSD; Research grant / Funding (self): Neon Therapeutics . J. Rizzo: Honoraria (self), Full / Part-time employment: BristolMyers Squibb. A. Balogh: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bristol-Myers Squibb. F..S. Hodi: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self): Merck, EMD Serono, Takeda, Surface, ; Honoraria (self): Genentech/Roche, Compass Therapeutics,; Honoraria (self): Apricity, Bayer, Aduro, Partners Therapeutics; Honoraria (self): Sanofi, Pfizer, Pionyr, Verastem; Honoraria (self): Rheos, Kairos, Bicara; Honoraria (self), Research grant / Funding (self): Novartis; Advisory / Consultancy, Shareholder / Stockholder / Stock options: Torque, 7 Hills Pharma, Psioxus Therapeutics ; Licensing / Royalties: patent Methods for Treating MICA-Related Disorders (#20100111973) with royalties paid; a patent Tumor Antigens and Uses Thereof (#7250291) issued; a patent Angiopoiten-2 Biomarkers Predictive of Anti-Immune Checkpoint Response (#20170248603) pending; a . J. Wolchok: Patent information: Xenogeneic DNA Vaccines; Alphavirus Replicon Particles Expressing TRP2; Myeloid-derived Suppressor cell (MDSC) assay; Newcastle Disease Viruses for Cancer Therapy; Genomic Signature to Identify Responders to Ipilimumab in Melanoma; Engineered Vaccinia Viruses for Cancer Immunotherapy; Anti-CD40 agonist mAb fused to Monophosphoryl Lipid A (MPL) for cancer therapy; CARþ T cells targeting differentiation antigens as means to treat cancer; Anti-PD1 Antibody; Anti-CTLA4 antibodies; Anti-GITR antibodies and methods of use thereof; Honoraria (self), Research grant / Funding (self): Bristol-Myers Squibb ; Honoraria (self): Advaxis, Elucida, Amgen, Eli Lilly; Honoraria (self): Apricity, F Star, Array BioPharma, Imvaq; Honoraria (self): Ascentage, Janssen, Astellas, Kleo; Honoraria (self): Bayer, Merck, Adaptive Biotech, Neon Therapeutics; Honoraria (self): Beigene, ONO, Celgene, Polaris Pharma; Honoraria (self): Chugai, Polynoma, PsiOxus, Puretech; Honoraria (self): Recepta, Sellas Life Sciences; Honoraria (self): Serametrix, Surface, Syndax; Advisory / Consultancy, Shareholder / Stockholder / Stock options: Potenza Therapeutics, Tizona Pharma; Honoraria (self), Research grant / Funding (self): Genentech, MedImmune; Advisory / Consultancy, Shareholder / Stockholder / Stock options: Trieza, Linneaus. All other authors have declared no conflicts of interest.

doi:10.1093/annonc/mdz394 | v905

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Objective response rate, % (95% CI) Median duration of response, mo (95% CI) Median PFS, mo (95% CI) 5-year PFS rate, % (95% CI) Median OS, mo (95% CI) 5-year OS rate, % (95% CI) BRAF mutant BRAF wild-type PD-L1 < 5% PD-L1  5% Median time from randomization to subsequent systemic therapy, mo (95% CI) Patients alive and free from subsequent therapy, n/N (%)

NIVOþIPI (n ¼ 314)