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Presidential Symposium III

5646 - Adjuvant therapy with nivolumab (NIVO) versus ipilimumab (IPI) after complete resection of stage III/IV melanoma: a randomized, double-blind, phase 3 trial (CheckMate 238)

Date

11 Sep 2017

Session

Presidential Symposium III

Presenters

Jeffrey Weber

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

J. Weber1, M. Mandala2, M. Del Vecchio3, H. Gogas4, A.M. Arance5, L.C. Cowey6, S. Dalle7, M. Schenker8, V. Chiarion-Sileni9, I. Márquez-Rodas10, J. Grob11, M. Butler12, M.R. Middleton13, M. Maio14, V. Atkinson15, P. Queirolo16, V. de Pril17, A. Qureshi17, J. Larkin18, P.A. Ascierto19

Author affiliations

  • 1 Perlmutter Cancer Center, NYU Langone Health, 10016 - New York/US
  • 2 Oncology, Papa Giovanni XIII Hospital, Bergamo/IT
  • 3 Medical Oncology, National Cancer Institute, Milan/IT
  • 4 Oncology, University of Athens, Athens/GR
  • 5 Oncology, Hospital Clinic de Barcelona, Barcelona/ES
  • 6 Oncology, Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas/US
  • 7 Oncology, Hospices Civils de Lyon, Pierre Bénite/FR
  • 8 Oncology, Oncology Center sf. Nectarie Ltd., Craiova/RO
  • 9 Oncology, Oncology Institute of Veneto IRCCS, Padua/IT
  • 10 Medical Oncology, Hospital Gregorio Marañón, Madrid/ES
  • 11 Medical Oncology, Hospital de la Timone, Marseille/FR
  • 12 Oncology, Princess Margaret Cancer Centre, Toronto/CA
  • 13 Oncology, Churchill Hospital, University of Oxford, OX3 7LE - Oxford/GB
  • 14 Center For Immuno-oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena/IT
  • 15 Oncology, Gallipoli Medical Research Foundation and Princess Alexandra Hospital, and University of Queensland, Queensland/AU
  • 16 Oncology, IRCCS AOU San Martino - IST, 16132 - Genova/IT
  • 17 Global Clinical Research - Oncology, Bristol-Myers Squibb, Princeton/US
  • 18 Oncology, The Royal Marsden Hospital, London/GB
  • 19 Oncology, Istituto Nazionale Tumori Fondazione Pascale, 80131 - Naples/IT
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Abstract 5646

Background

NIVO and IPI are immune checkpoint inhibitors approved for advanced melanoma. IPI is also approved in the US for resected stage III melanoma, based on a phase 3 trial demonstrating an improvement in recurrence-free survival (RFS). We report the first results of a phase 3 trial designed to evaluate NIVO vs IPI for resected stage III/IV melanoma at high risk of recurrence.

Methods

In this randomized, double-blind trial, eligible patients (pts) included those ≥15 yrs of age who underwent complete resection of stage IIIb/c or IV melanoma. 906 pts were randomized (stratified by stage and PD-L1 status) 1:1 to receive NIVO 3 mg/kg (n = 453) every 2 wks or IPI 10 mg/kg (n = 453) every 3 wks for 4 doses, then every 12 wks (from week 24) for up to 1 yr, disease recurrence, or unacceptable toxicity. The primary endpoint was RFS in the intent-to-treat population.

Results

Overall, 34%/47%/19% of pts had stage IIIb/IIIc/IV; 32%, ulcerated primary; 48%, macroscopic lymph node involvement; and 42%, BRAF mutation. At a median follow-up of 18.5 mo, NIVO significantly improved RFS vs IPI (Table). Results from prespecified subgroup analyses demonstrated consistent hazard ratios favoring NIVO.

Table:

LBA8_PR

NIVO (N = 453)IPI (N = 453)
18-mo RFS rates (95% CI)66.4% (61.8–70.6)52.7% (47.8–57.4)
Median RFSNot reachedNot reached
HR (95% CI)0.65 (0.51–0.83)
Log-rankP 100 days post-IPI.

Conclusions

NIVO as adjuvant therapy significantly improved RFS vs IPI for pts with stage III/IV melanoma at high risk of recurrence and demonstrated a superior safety profile. Acknowledgement: The co-senior authors for this abstract are Dr. J. Larkin and Dr. P.A. Ascierto.

Clinical trial identification

NCT02388906

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

Bristol-Myers Squibb

Disclosure

J. Weber: Celldex, Ichor Medical Systems, cCam Biotherapeutics, Lion Biotechnologies, Pieris Pharmaceuticals, Altor BioScience, Bristol-Myers Squibb, Merck, Genentech, Roche, Amgen, AstraZeneca, GlaxoSmithKline, Daiichi Sankyo, Abbvie, Eisai, CytomX Therapeutics, Nektar, Novartis, Medivation: consulting or advisory role; Bristol-Myers Squibb, GlaxoSmithKline, Daiichi Sankyo, Pieris Pharmaceuticals, cCam Biotherapeutics, Lion Biotechnologies, Roche, Celldex, Amgen, Merck, AstraZeneca, Genentech, Novartis: travel, accommodations, expenses; Named on a patent submitted by Moffitt Cancer Center for an ipilimumab biomarker; Altor BioScience, Celldex, CytomX Therapeutics: stock and other ownership interests; Bristol-Myers Squibb, Merck, Genentech, Abbvie, AstraZeneca, Daiichi Sankyo, GlaxoSmithKline, Eisai, Altor BioScience, Altor BioScience, Amgen, Roche, Ichor Medical Systems, Celldex, cCam Biotherapeutics, Pieris Pharmaceuticals, CytomX Therapeutics, Nektar, Novartis, Medivation: honoraria; Bristol-Myers Squibb, Merck, Gla. M. Mandala: Roche: personal fees, grant; BMS, MSD, Novartis: personal fees. M. Del Vecchio: BMS: personal fees, honoraria; Roche: personal fees, honoraria, advisory board, research funding; GSK: personal fees, honoraria. H. Gogas: Roche, Amgen MSD, BMS, Novartis: consulting or advisory role, research funding; BMS, Roche, MSD: travel accommodations, expenses. A.M. Arance: GSK, Roche, personal fees, Consultant, speakers\' bureau; BMS: personal fees & non-financial support, Speakers\' bureau, travel funding. L.C. Cowey: BMS, Genentech: grant, personal fees, consultant, Speaker, Research funding; Merck, GSK: grant, consultant, Research funding. S. Dalle: BMS: research grants and travel expenses; BMS, MSD, Novartis, Roche: principal investigator V. Chiarion-Sileni: BMS, Roche, GSK: personal fees, consulting, speakers\' bureau, travel; MSD: personal fees, consulting, travel. I. Márquez-Rodas: Novartis, Roche, MSD, BMS: honoraria; Novartis, Roche, MSD, BMS, Amgen, Bioncotech: consulting or advisory role; MSD, BMS, Amgen: travel, accommodations, expenses. J-J. Grob: BMS: personal fees, consultant, speakers\' bureau, research funding; GSK: personal fees, consultant, speakers\' bureau; Novartis: personal fees, consulting; Roche: personal fees, non-financial support, consulting, speakers\' bureau, research funding, travel; Merck, Amgen: personal fees, consulting M. Butler: Bristol Myers Squib, EMD Serono, Immunocore, Immunovaccine: personal fees, advisory boards; Merck: grant, personal fees, advisory boards, grant support for clinical trial. M.R. Middleton: Amgen, Bristol-Myers Squibb, Clovis, GlaxoSmithKline, Immunocore (uncompensated), Merck, Roche (all compensated): consulting or advisory role; Amgen, AstraZeneca, Bristol-Myers Squibb, Clovis, Eisai, GlaxoSmithKline, Immunocore, Medimmune, Merck, Pfizer, Roche, Vertex: research funding; Merck, Roche: travel, accommodations, expenses. M. Maio: BMS, Roche, MedImmune, MSD, GSK: honoraria, consulting or advisory role, travel, accommodations, expenses; BMS, MedImmune: research funding. V. Atkinson: BMS, MSD, Novartis: honoraria, consulting or advisory role, speakers\' bureau, travel, accommodations, expenses. P. Queirolo: Roche, MSD, BMS, Novartis: personal fees. V. de Pril, A. Qureshi: employment – Bristol-Myers Squibb and stock/ownership – Bristol-Myers Squibb J. Larkin: BMS, MSD, Novartis, Pfizer: research funding; BMS, MSD, Pfizer, Eisai, GSK, Roche: travel, accommodations, expenses. P.A. Ascierto: Bristol-Myers Squibb, Roche-Genentech: grant, personal fees, honoraria, consultant, institutional research funding; GSK: personal fees, honoraria, consultant; MSD, personal fees, consultant; Ventana: grant, consultant, institutional research funding; Novartis: Consultant. All other authors have declared no conflicts of interest.

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