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Melanoma and other skin tumours

1546 - Characterization of complete responses (CRs) in patients with advanced melanoma (MEL) who received the combination of nivolumab (NIVO) and ipilimumab (IPI), NIVO or IPI alone

Date

09 Sep 2017

Session

Melanoma and other skin tumours

Presenters

Caroline Robert

Citation

Annals of Oncology (2017) 28 (suppl_5): v428-v448. 10.1093/annonc/mdx377

Authors

C. Robert1, J. Larkin2, P.A. Ascierto3, G.V. Long4, J.C. Hassel5, D. Schadendorf6, F..S. Hodi7, C. Lebbé8, J. Grob9, K. Grossmann10, J. Wagstaff11, J. Chesney12, D. Hogg13, O. Bechter14, I. Márquez-Rodas15, A.C. Pavlick16, D. Walker17, R. Bhore17, M.A. Postow18, J.D. Wolchok18

Author affiliations

  • 1 Department Of Medicine, Gustave Roussy and INSERM Unité 981, 94800 - Villejuif–Paris Sud/FR
  • 2 Medicine, Royal Marsden Hospital, London/GB
  • 3 Melanoma, Cancer Immunotherapy And Innovative Therapy Unit, Istituto Nazionale Tumori Fondazione Pascale, 80131 - Naples/IT
  • 4 Melanoma Medical Oncology, Melanoma Institute Australia, The University of Sydney and Royal North Shore and Mater Hospitals, Sydney/AU
  • 5 Department Of Dermatology, University Hospital Heidelberg, Heidelberg/DE
  • 6 Department Of Dermatology, University of Essen , 45417 - Essen/DE
  • 7 Medical Oncology, Dana-Farber Cancer Institute, Boston/US
  • 8 Ap-hp Dermatology Cic Departments, Saint-Louis Hospital, INSERM U976, Université Paris Diderot, Paris/FR
  • 9 Dermatology, Hospital de la Timone, Marseille/FR
  • 10 Oncology, Huntsman Cancer Institute, Salt Lake City/US
  • 11 Medical Oncology, Singleton Hospital, South West Wales Cancer Institute & Swansea University College of Medicine, Swansea/GB
  • 12 Department Of Medicine, University of Louisville, Louisville/US
  • 13 Cancer Clinical Research Unit (ccru), Princess Margaret Cancer Centre, Toronto/CA
  • 14 Oncology, UZ Leuven, Leuven/BE
  • 15 Medical Oncology, Hospital Gregorio Maranon, Madrid/ES
  • 16 Department Of Medicine, New York University, New York/US
  • 17 Oncology, Bristol-Myers Squibb, Princeton/US
  • 18 Oncology, Memorial-Sloan Kettering Cancer Center and Weill Cornell Medical College, New York/US
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Abstract 1546

Background

In clinical studies, 10-15% of patients (pts) treated with anti-PD-1 monotherapies achieved durable CRs. Combination treatment with NIVO+IPI resulted in higher response rates, longer progression-free survival (PFS), and improved overall survival (OS) vs IPI alone, but with an increased frequency of adverse events (AEs). Here, we characterized CRs among pts who received combination therapy vs NIVO or IPI alone.

Methods

In this post hoc analysis, efficacy and safety data were pooled for NIVO+IPI (N = 409), NIVO (N = 526), and IPI (N = 362) from the phase 2 CheckMate 069, phase 3 CheckMate 066, and phase 3 CheckMate 067 studies in pts with MEL. Across studies, the minimum duration of follow-up was 24 months (median ∼31 months).

Results

In the pooled analysis, the CR rate was 18% for NIVO+IPI, 16% for NIVO, and 4% for IPI, with partial responses (PRs) in 41%, 28%, and 14% of pts, respectively (Table). Among the 75 CR pts in the NIVO+IPI cohort, the majority (77%) are off treatment and 8% received a subsequent systemic therapy; 15% had elevated LDH levels and 32% had M1c disease. Median duration of CR has not been reached, with 63/75 pts (84%) remaining in response. After an additional follow-up of 12 months (from the 1-year initial follow-up), 24/166 pts (14%) with a PR converted to a CR. For the 75 CR pts in the NIVO+IPI cohort, 2-year PFS and OS rates were 86% and 92%, respectively. Treatment-related AEs of grade 3-4 occurred in 60% of NIVO+IPI-treated pts with a CR, 65% with a PR, and in 60% with stable disease; 31%, 36%, and 35%, respectively, led to discontinuation. There were no treatment-related deaths.Table:

1213O

NIVO+IPI (N = 409)NIVO (N = 526)IPI (N = 362)
Objective response rate (%)58.943.918.0
CR, n (%)75 (18)83 (16)14 (4)
PR, n (%)166 (41)148 (28)51 (14)
Pts remaining in response (CR)63/75 (84%)75/83 (90%)11/14 (79%)
CR pts continuing on treatment17/75 (23%)41/83 (49%)4/14 (29%)
CR pts not continuing on treatment58/75 (77%)42/83 (51%)10/14 (71%)

Conclusions

MEL pts treated with NIVO+IPI had a high rate of durable CRs, with the majority remaining in response and often not requiring additional treatment at a median follow-up of ∼31 months. Some pts with a PR convert to a CR over time. Updated analyses based on 3-year data will be presented.

Clinical trial identification

NCT01844505 (067) NCT01721772 (066) NCT01927419 (069)

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

Bristol-Myers Squibb

Disclosure

C. Robert: Served as a consultant for Amgen, Bristol-Myers Squibb, Merck, and Roche; paid honoraria from Amgen, Bristol-Myers Squibb, GSK, Merck, Novartis, and Roche. J. Larkin: Received research funding from Bristol-Myers Squibb, MSD, Novartis, and Pfizer; travel funding from Bristol-Myers Squibb, GSK, MSD, Esai, Pfizer, and Roche. P.A. Ascierto: Served as a consultant for Amgen, Array, Bristol-Myers Squibb, Merck-Serono, MSD, Novartis, Pierre-Fabre, and Roche-Genentech; institution received research funding from Array, Bristol-Myers Squibb, and Roche-Genentech. G.V. Long: Served as a consultant for Amgen, Bristol-Myers Squibb, Merck, MSD, Novartis, Pierre-Fabre, and Roche; paid honoraria from Bristol-Myers Squibb, Merck, MSD, and Roche. J.C. Hassel: Funding for trial procedures according to study protocol from Bristol-Myers Squibb; honoraria from Amgen, Bristol-Myers Squibb, GSK, MSD, Novartis, and Roche; research grant/funding from Bristol-Myers Squibb; travel funding from Amgen, Bristol-Myers Squibb, GSK, MSD, Novartis, and Roche. D. Schadendorf: Served as a consultant or advisor for Roche/Genentech, Novartis, Bristol-Myers Squibb, Merck Sharp & Dohme, Merck Serono, Sysmex, Amgen, Grunenthal Group, Immunocore; participated on a speakers’ bureau for Roche, Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis, Amgen, Incyte, Pierre Fabre; travel funding from Roche/Genentech, Bristol-Myers Squibb, Amgen, Merck, Merck Serono, Novartis; paid honoraria from Roche/Genentech, Novartis, Amgen, Bristol-Myers Squibb, Merck Sharp & Dohme, Sysmex, Immunocore, Grunenthal Group, Merck Serono, Agenus, Array BioPharma, LEO Pharma, Incyte, Pfizer, Pierre Fabre, Philogen, Regeneron; received institutional research funding from Bristol-Myers Squibb and Novartis. F.S. Hodi: Consultant: Amgen, EMD Serono, MSD, Novartis, Roche-GNE; travel funding: Bristol-Myers Squibb and Novartis; patent pending royalties per institutional policy; other: B Bristol-Myers Squibb MS; institutional research funding: Bristol-Myers Squibb, MSD, Novartis, Roche-GNE. C. Lebbé: Served on an advisory board for Bristol-Myers Squibb, GSK, MSD, Novartis, and Roche. J-J. Grob: Served as a consultant to Amgen, Bristol-Myers Squibb, GSK, Merck, Novartis, and Roche; participated on speakers’ bureau for Bristol-Myers Squibb, GSK, and Roche; travel funding from Roche; recipient of research funding from Bristol-Myers Squibb and Roche. J. Wagstaff: Honoraria from Astellas, Bristol-Myers Squibb, Merck, Novartis, Pfizer, and Roche; consultant to Astellas, Bristol-Myers Squibb, Merck, Novartis, Pfizer, and Roche; served on speakers’ bureaus for Astellas, Bristol-Myers Squibb, and Novartis; travel funding from Astellas, Bristol-Myers Squibb, and Novartis. J. Chesney: Served as a consultant to Bristol-Myers Squibb; received research funding from Bristol-Myers Squibb. D. Hogg: Served as a consultant to Bristol-Myers Squibb, GSK, Novartis, and Roche. O. Bechter: Served as a consultant or advisor to Bristol-Myers Squibb; and received travel funding from Roche. I. Márquez-Rodas: Honoraria from Bristol-Myers Squibb, MSD, Novartis, and Roche; served as a consultant to Amgen, Bioncotech, Bristol-Myers Squibb, MSD, Novartis, and Roche; travel funding from Amgen, Bristol-Myers Squibb, and MSD. D. Walker: Employee of Bristol-Myers Squibb; immediate family member has stock or other ownership in Antares Pharma. R. Bhore: Employee of and owns stock in Bristol-Myers Squibb. M.A. Postow: Served on an advisory board for Bristol-Myers Squibb; recipient of research grant support from Bristol-Myers Squib. J.D. Wolchok: Consultant: Bristol-Myers Squibb, GSK, Jounce, MedImmune, Merck, Polaris, Polynoma, and Ziopharm; research funding: Bristol-Myers Squibb, GSK, MedImmune, and Merck; patent issued for DNA vaccine of cancer in companion animals (co-investor). All other authors have declared no conflicts of interest.

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