Combined nivolumab and ipilimumab or monotherapy in untreated Melanoma

J. Larkin; V. Chiarion-Sileni; R. Gonzalez; J. J. Grob; C. L. Cowey; C. D. Lao; D. Schadendorf; R. Dummer; M. Smylie; P. Rutkowski; P. F. Ferrucci; A. Hill; J. Wagstaff; M. S. Carlino; J. B. Haanen; M. Maio; I. Marquez-Rodas; G. A. McArthur; P. A. Ascierto; G. V. Long; M. K. Callahan; M. A. Postow; K. Grossmann; M. Sznol; B. Dreno; L. Bastholt; A. Yang; L. M. Rollin; C. Horak; F. S. Hodi; J. D. Wolchok

doi:10.1056/NEJMoa1504030

Combined nivolumab and ipilimumab or monotherapy in untreated Melanoma

J. Larkin, V. Chiarion-Sileni, R. Gonzalez, J. J. Grob, C. L. Cowey, C. D. Lao, D. Schadendorf, R. Dummer, M. Smylie, P. Rutkowski, P. F. Ferrucci, A. Hill, J. Wagstaff, M. S. Carlino, J. B. Haanen, M. Maio, I. Marquez-Rodas, G. A. McArthur, P. A. Ascierto, G. V. LongM. K. Callahan, M. A. Postow, K. Grossmann, M. Sznol, B. Dreno, L. Bastholt, A. Yang, L. M. Rollin, C. Horak, F. S. Hodi, J. D. Wolchok

Research output: Contribution to journal › Article › peer-review

Abstract

BACKGROUND Nivolumab (a programmed death 1 [PD-1] checkpoint inhibitor) and ipilimumab (a cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4] checkpoint inhibitor) have been shown to have complementary activity in metastatic melanoma. In this randomized, double-blind, phase 3 study, nivolumab alone or nivolumab plus ipilimumab was compared with ipilimumab alone in patients with metastatic melanoma. METHODS We assigned, in a 1:1:1 ratio, 945 previously untreated patients with unresectable stage III or IV melanoma to nivolumab alone, nivolumab plus ipilimumab, or ipilimumab alone. Progression-free survival and overall survival were coprimary end points. Results regarding progression-free survival are presented here. RESULTS The median progression-free survival was 11.5 months (95% confidence interval [CI], 8.9 to 16.7) with nivolumab plus ipilimumab, as compared with 2.9 months (95% CI, 2.8 to 3.4) with ipilimumab (hazard ratio for death or disease progression, 0.42; 99.5% CI, 0.31 to 0.57; P

Original language	English
Pages (from-to)	23-34
Number of pages	12
Journal	New England Journal of Medicine
Volume	373
Issue number	1
DOIs	https://doi.org/10.1056/NEJMoa1504030
Publication status	Published - Jul 2 2015

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Medicine(all)

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10.1056/NEJMoa1504030

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Larkin, J., Chiarion-Sileni, V., Gonzalez, R., Grob, J. J., Cowey, C. L., Lao, C. D., Schadendorf, D., Dummer, R., Smylie, M., Rutkowski, P., Ferrucci, P. F., Hill, A., Wagstaff, J., Carlino, M. S., Haanen, J. B., Maio, M., Marquez-Rodas, I., McArthur, G. A., Ascierto, P. A., ... Wolchok, J. D. (2015). Combined nivolumab and ipilimumab or monotherapy in untreated Melanoma. New England Journal of Medicine, 373(1), 23-34. https://doi.org/10.1056/NEJMoa1504030

Larkin, J, Chiarion-Sileni, V, Gonzalez, R, Grob, JJ, Cowey, CL, Lao, CD, Schadendorf, D, Dummer, R, Smylie, M, Rutkowski, P, Ferrucci, PF, Hill, A, Wagstaff, J, Carlino, MS, Haanen, JB, Maio, M, Marquez-Rodas, I, McArthur, GA, Ascierto, PA, Long, GV, Callahan, MK, Postow, MA, Grossmann, K, Sznol, M, Dreno, B, Bastholt, L, Yang, A, Rollin, LM, Horak, C, Hodi, FS & Wolchok, JD 2015, 'Combined nivolumab and ipilimumab or monotherapy in untreated Melanoma', New England Journal of Medicine, vol. 373, no. 1, pp. 23-34. https://doi.org/10.1056/NEJMoa1504030

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title = "Combined nivolumab and ipilimumab or monotherapy in untreated Melanoma",

abstract = "BACKGROUND Nivolumab (a programmed death 1 [PD-1] checkpoint inhibitor) and ipilimumab (a cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4] checkpoint inhibitor) have been shown to have complementary activity in metastatic melanoma. In this randomized, double-blind, phase 3 study, nivolumab alone or nivolumab plus ipilimumab was compared with ipilimumab alone in patients with metastatic melanoma. METHODS We assigned, in a 1:1:1 ratio, 945 previously untreated patients with unresectable stage III or IV melanoma to nivolumab alone, nivolumab plus ipilimumab, or ipilimumab alone. Progression-free survival and overall survival were coprimary end points. Results regarding progression-free survival are presented here. RESULTS The median progression-free survival was 11.5 months (95% confidence interval [CI], 8.9 to 16.7) with nivolumab plus ipilimumab, as compared with 2.9 months (95% CI, 2.8 to 3.4) with ipilimumab (hazard ratio for death or disease progression, 0.42; 99.5% CI, 0.31 to 0.57; P",

author = "J. Larkin and V. Chiarion-Sileni and R. Gonzalez and Grob, {J. J.} and Cowey, {C. L.} and Lao, {C. D.} and D. Schadendorf and R. Dummer and M. Smylie and P. Rutkowski and Ferrucci, {P. F.} and A. Hill and J. Wagstaff and Carlino, {M. S.} and Haanen, {J. B.} and M. Maio and I. Marquez-Rodas and McArthur, {G. A.} and Ascierto, {P. A.} and Long, {G. V.} and Callahan, {M. K.} and Postow, {M. A.} and K. Grossmann and M. Sznol and B. Dreno and L. Bastholt and A. Yang and Rollin, {L. M.} and C. Horak and Hodi, {F. S.} and Wolchok, {J. D.}",

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T1 - Combined nivolumab and ipilimumab or monotherapy in untreated Melanoma

AU - Larkin, J.

AU - Chiarion-Sileni, V.

AU - Gonzalez, R.

AU - Grob, J. J.

AU - Cowey, C. L.

AU - Lao, C. D.

AU - Schadendorf, D.

AU - Dummer, R.

AU - Smylie, M.

AU - Rutkowski, P.

AU - Ferrucci, P. F.

AU - Hill, A.

AU - Wagstaff, J.

AU - Carlino, M. S.

AU - Haanen, J. B.

AU - Maio, M.

AU - Marquez-Rodas, I.

AU - McArthur, G. A.

AU - Ascierto, P. A.

AU - Long, G. V.

AU - Callahan, M. K.

AU - Postow, M. A.

AU - Grossmann, K.

AU - Sznol, M.

AU - Dreno, B.

AU - Bastholt, L.

AU - Yang, A.

AU - Rollin, L. M.

AU - Horak, C.

AU - Hodi, F. S.

AU - Wolchok, J. D.

PY - 2015/7/2

Y1 - 2015/7/2

N2 - BACKGROUND Nivolumab (a programmed death 1 [PD-1] checkpoint inhibitor) and ipilimumab (a cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4] checkpoint inhibitor) have been shown to have complementary activity in metastatic melanoma. In this randomized, double-blind, phase 3 study, nivolumab alone or nivolumab plus ipilimumab was compared with ipilimumab alone in patients with metastatic melanoma. METHODS We assigned, in a 1:1:1 ratio, 945 previously untreated patients with unresectable stage III or IV melanoma to nivolumab alone, nivolumab plus ipilimumab, or ipilimumab alone. Progression-free survival and overall survival were coprimary end points. Results regarding progression-free survival are presented here. RESULTS The median progression-free survival was 11.5 months (95% confidence interval [CI], 8.9 to 16.7) with nivolumab plus ipilimumab, as compared with 2.9 months (95% CI, 2.8 to 3.4) with ipilimumab (hazard ratio for death or disease progression, 0.42; 99.5% CI, 0.31 to 0.57; P

AB - BACKGROUND Nivolumab (a programmed death 1 [PD-1] checkpoint inhibitor) and ipilimumab (a cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4] checkpoint inhibitor) have been shown to have complementary activity in metastatic melanoma. In this randomized, double-blind, phase 3 study, nivolumab alone or nivolumab plus ipilimumab was compared with ipilimumab alone in patients with metastatic melanoma. METHODS We assigned, in a 1:1:1 ratio, 945 previously untreated patients with unresectable stage III or IV melanoma to nivolumab alone, nivolumab plus ipilimumab, or ipilimumab alone. Progression-free survival and overall survival were coprimary end points. Results regarding progression-free survival are presented here. RESULTS The median progression-free survival was 11.5 months (95% confidence interval [CI], 8.9 to 16.7) with nivolumab plus ipilimumab, as compared with 2.9 months (95% CI, 2.8 to 3.4) with ipilimumab (hazard ratio for death or disease progression, 0.42; 99.5% CI, 0.31 to 0.57; P

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DO - 10.1056/NEJMoa1504030

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JO - New England Journal of Medicine

JF - New England Journal of Medicine

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ER -

Combined nivolumab and ipilimumab or monotherapy in untreated Melanoma

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