Nivolumab in previously untreated melanoma without BRAF mutation

Caroline Robert, Georgina V. Long, Benjamin Brady, Caroline Dutriaux, Michele Maio, Laurent Mortier, Jessica C. Hassel, Piotr Rutkowski, Catriona McNeil, Ewa Kalinka-Warzocha, Kerry J. Savage, Micaela M. Hernberg, Celeste Lebbé, Julie Charles, Catalin Mihalcioiu, Vanna Chiarion-Sileni, Cornelia Mauch, Francesco Cognetti, Ana Arance, Henrik Schmidt & 8 others Dirk Schadendorf, Helen Gogas, Lotta Lundgren-Eriksson, Christine Horak, Brian Sharkey, Ian M. Waxman, Victoria Atkinson, Paolo A. Ascierto

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: Nivolumab was associated with higher rates of objective response than chemotherapy in a phase 3 study involving patients with ipilimumab-refractory metastatic melanoma. The use of nivolumab in previously untreated patients with advanced melanoma has not been tested in a phase 3 controlled study.

METHODS: We randomly assigned 418 previously untreated patients who had metastatic melanoma without a BRAF mutation to receive nivolumab (at a dose of 3 mg per kilogram of body weight every 2 weeks and dacarbazine-matched placebo every 3 weeks) or dacarbazine (at a dose of 1000 mg per square meter of body-surface area every 3 weeks and nivolumab-matched placebo every 2 weeks). The primary end point was overall survival.

RESULTS: At 1 year, the overall rate of survival was 72.9% (95% confidence interval [CI], 65.5 to 78.9) in the nivolumab group, as compared with 42.1% (95% CI, 33.0 to 50.9) in the dacarbazine group (hazard ratio for death, 0.42; 99.79% CI, 0.25 to 0.73; P

CONCLUSIONS: Nivolumab was associated with significant improvements in overall survival and progression-free survival, as compared with dacarbazine, among previously untreated patients who had metastatic melanoma without a BRAF mutation. (Funded by Bristol-Myers Squibb; CheckMate 066 ClinicalTrials.gov number, NCT01721772.).

Original languageEnglish
Pages (from-to)320-330
Number of pages11
JournalNew England Journal of Medicine
Volume372
Issue number4
DOIs
Publication statusPublished - Jan 22 2015

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Melanoma
Dacarbazine
Mutation
Confidence Intervals
Placebos
Survival
Body Surface Area
Disease-Free Survival
nivolumab
Survival Rate
Body Weight
Drug Therapy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Nivolumab in previously untreated melanoma without BRAF mutation. / Robert, Caroline; Long, Georgina V.; Brady, Benjamin; Dutriaux, Caroline; Maio, Michele; Mortier, Laurent; Hassel, Jessica C.; Rutkowski, Piotr; McNeil, Catriona; Kalinka-Warzocha, Ewa; Savage, Kerry J.; Hernberg, Micaela M.; Lebbé, Celeste; Charles, Julie; Mihalcioiu, Catalin; Chiarion-Sileni, Vanna; Mauch, Cornelia; Cognetti, Francesco; Arance, Ana; Schmidt, Henrik; Schadendorf, Dirk; Gogas, Helen; Lundgren-Eriksson, Lotta; Horak, Christine; Sharkey, Brian; Waxman, Ian M.; Atkinson, Victoria; Ascierto, Paolo A.

In: New England Journal of Medicine, Vol. 372, No. 4, 22.01.2015, p. 320-330.

Research output: Contribution to journalArticle

Robert, C, Long, GV, Brady, B, Dutriaux, C, Maio, M, Mortier, L, Hassel, JC, Rutkowski, P, McNeil, C, Kalinka-Warzocha, E, Savage, KJ, Hernberg, MM, Lebbé, C, Charles, J, Mihalcioiu, C, Chiarion-Sileni, V, Mauch, C, Cognetti, F, Arance, A, Schmidt, H, Schadendorf, D, Gogas, H, Lundgren-Eriksson, L, Horak, C, Sharkey, B, Waxman, IM, Atkinson, V & Ascierto, PA 2015, 'Nivolumab in previously untreated melanoma without BRAF mutation', New England Journal of Medicine, vol. 372, no. 4, pp. 320-330. https://doi.org/10.1056/NEJMoa1412082
Robert C, Long GV, Brady B, Dutriaux C, Maio M, Mortier L et al. Nivolumab in previously untreated melanoma without BRAF mutation. New England Journal of Medicine. 2015 Jan 22;372(4):320-330. https://doi.org/10.1056/NEJMoa1412082
Robert, Caroline ; Long, Georgina V. ; Brady, Benjamin ; Dutriaux, Caroline ; Maio, Michele ; Mortier, Laurent ; Hassel, Jessica C. ; Rutkowski, Piotr ; McNeil, Catriona ; Kalinka-Warzocha, Ewa ; Savage, Kerry J. ; Hernberg, Micaela M. ; Lebbé, Celeste ; Charles, Julie ; Mihalcioiu, Catalin ; Chiarion-Sileni, Vanna ; Mauch, Cornelia ; Cognetti, Francesco ; Arance, Ana ; Schmidt, Henrik ; Schadendorf, Dirk ; Gogas, Helen ; Lundgren-Eriksson, Lotta ; Horak, Christine ; Sharkey, Brian ; Waxman, Ian M. ; Atkinson, Victoria ; Ascierto, Paolo A. / Nivolumab in previously untreated melanoma without BRAF mutation. In: New England Journal of Medicine. 2015 ; Vol. 372, No. 4. pp. 320-330.
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abstract = "BACKGROUND: Nivolumab was associated with higher rates of objective response than chemotherapy in a phase 3 study involving patients with ipilimumab-refractory metastatic melanoma. The use of nivolumab in previously untreated patients with advanced melanoma has not been tested in a phase 3 controlled study.METHODS: We randomly assigned 418 previously untreated patients who had metastatic melanoma without a BRAF mutation to receive nivolumab (at a dose of 3 mg per kilogram of body weight every 2 weeks and dacarbazine-matched placebo every 3 weeks) or dacarbazine (at a dose of 1000 mg per square meter of body-surface area every 3 weeks and nivolumab-matched placebo every 2 weeks). The primary end point was overall survival.RESULTS: At 1 year, the overall rate of survival was 72.9{\%} (95{\%} confidence interval [CI], 65.5 to 78.9) in the nivolumab group, as compared with 42.1{\%} (95{\%} CI, 33.0 to 50.9) in the dacarbazine group (hazard ratio for death, 0.42; 99.79{\%} CI, 0.25 to 0.73; PCONCLUSIONS: Nivolumab was associated with significant improvements in overall survival and progression-free survival, as compared with dacarbazine, among previously untreated patients who had metastatic melanoma without a BRAF mutation. (Funded by Bristol-Myers Squibb; CheckMate 066 ClinicalTrials.gov number, NCT01721772.).",
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AU - Robert, Caroline

AU - Long, Georgina V.

AU - Brady, Benjamin

AU - Dutriaux, Caroline

AU - Maio, Michele

AU - Mortier, Laurent

AU - Hassel, Jessica C.

AU - Rutkowski, Piotr

AU - McNeil, Catriona

AU - Kalinka-Warzocha, Ewa

AU - Savage, Kerry J.

AU - Hernberg, Micaela M.

AU - Lebbé, Celeste

AU - Charles, Julie

AU - Mihalcioiu, Catalin

AU - Chiarion-Sileni, Vanna

AU - Mauch, Cornelia

AU - Cognetti, Francesco

AU - Arance, Ana

AU - Schmidt, Henrik

AU - Schadendorf, Dirk

AU - Gogas, Helen

AU - Lundgren-Eriksson, Lotta

AU - Horak, Christine

AU - Sharkey, Brian

AU - Waxman, Ian M.

AU - Atkinson, Victoria

AU - Ascierto, Paolo A.

PY - 2015/1/22

Y1 - 2015/1/22

N2 - BACKGROUND: Nivolumab was associated with higher rates of objective response than chemotherapy in a phase 3 study involving patients with ipilimumab-refractory metastatic melanoma. The use of nivolumab in previously untreated patients with advanced melanoma has not been tested in a phase 3 controlled study.METHODS: We randomly assigned 418 previously untreated patients who had metastatic melanoma without a BRAF mutation to receive nivolumab (at a dose of 3 mg per kilogram of body weight every 2 weeks and dacarbazine-matched placebo every 3 weeks) or dacarbazine (at a dose of 1000 mg per square meter of body-surface area every 3 weeks and nivolumab-matched placebo every 2 weeks). The primary end point was overall survival.RESULTS: At 1 year, the overall rate of survival was 72.9% (95% confidence interval [CI], 65.5 to 78.9) in the nivolumab group, as compared with 42.1% (95% CI, 33.0 to 50.9) in the dacarbazine group (hazard ratio for death, 0.42; 99.79% CI, 0.25 to 0.73; PCONCLUSIONS: Nivolumab was associated with significant improvements in overall survival and progression-free survival, as compared with dacarbazine, among previously untreated patients who had metastatic melanoma without a BRAF mutation. (Funded by Bristol-Myers Squibb; CheckMate 066 ClinicalTrials.gov number, NCT01721772.).

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