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Cited by 1,883

The DOI matches its Crossref record; 10 of the 10 references it cites were found in a registry or an index.

Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma

Open access
Tawbi, Hussein A., Schadendorf, Dirk, Lipson, Evan J., Ascierto, Paolo A., Matamala, Luis, Castillo Gutiérrez, Erika, Rutkowski, Piotr, Gogas, Helen J., Lao, Christopher D., De Menezes, Juliana Janoski, Dalle, Stéphane, Arance, Ana, Grob, Jean-Jacques, Srivastava, Shivani, Abaskharoun, Mena, Hamilton, Melissa, Keidel, Sarah, Simonsen, Katy L., Sobiesk, Anne Marie, Li, Bin, Hodi, F. Stephen, Long, Georgina V.·2022·New England Journal of Medicine
DOI 10.1056/nejmoa2109970
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Abstract

BACKGROUND: Lymphocyte-activation gene 3 (LAG-3) and programmed death 1 (PD-1) are distinct inhibitory immune checkpoints that contribute to T-cell exhaustion. The combination of relatlimab, a LAG-3-blocking antibody, and nivolumab, a PD-1-blocking antibody, has been shown to be safe and to have antitumor activity in patients with previously treated melanoma, but the safety and activity in patients with previously untreated melanoma need investigation. METHODS: In this phase 2-3, global, double-blind, randomized trial, we evaluated relatlimab and nivolumab as a fixed-dose combination as compared with nivolumab alone when administered intravenously every 4 weeks to patients with previously untreated metastatic or unresectable melanoma. The primary end point was progression-free survival as assessed by blinded independent central review. RESULTS: The median progression-free survival was 10.1 months (95% confidence interval [CI], 6.4 to 15.7) with relatlimab-nivolumab as compared with 4.6 months (95% CI, 3.4 to 5.6) with nivolumab (hazard ratio for progression or death, 0.75 [95% CI, 0.62 to 0.92]; P = 0.006 by the log-rank test). Progression-free survival at 12 months was 47.7% (95% CI, 41.8 to 53.2) with relatlimab-nivolumab as compared with 36.0% (95% CI, 30.5 to 41.6) with nivolumab. Progression-free survival across key subgroups favored relatlimab-nivolumab over nivolumab. Grade 3 or 4 treatment-related adverse events occurred in 18.9% of patients in the relatlimab-nivolumab group and in 9.7% of patients in the nivolumab group. CONCLUSIONS: The inhibition of two immune checkpoints, LAG-3 and PD-1, provided a greater benefit with regard to progression-free survival than inhibition of PD-1 alone in patients with previously untreated metastatic or unresectable melanoma. Relatlimab and nivolumab in combination showed no new safety signals. (Funded by Bristol Myers Squibb; RELATIVITY-047 ClinicalTrials.gov number, NCT03470922.).

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Research works printed but not linked: 15

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  6. Lipson E, Gopal A, Neelapu SS, et al. Initial experience administering BMS-986016, a monoclonal antibody that targets lymphocyte activation gene (LAG)-3, alone and in combination with nivolumab to patients with hematologic and solid malignancies. J Immunother Cancer 2016;4:Suppl 1:232-232. abstract.
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  8. American Joint Committee on Cancer. AJCC cancer staging manual. 8th ed. Chicago: American College of Surgeons, 2018.
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  11. Dillon LM Wojcik J Desai K et al. Distribution and prevalence of LAG-3 expression in samples of melanoma and gastric/gastroesophageal junction cancer. Cancer Res 2021;81:Suppl 13:1625. abstract. · DOI
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Metadata

Authors
Tawbi, H. A., Schadendorf, D., Lipson, E. J., Ascierto, P. A., Matamala, L., Castillo Gutiérrez, E., Rutkowski, P., Gogas, H. J., Lao, C. D., De Menezes, J. J., Dalle, S., Arance, A., Grob, J.-J., Srivastava, S., Abaskharoun, M., Hamilton, M., Keidel, S., Simonsen, K. L., Sobiesk, A. M., Li, B., Hodi, F. S., & Long, G. V.
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2022-01-06
Volume
386
Issue
1
Pages
24-34
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2109970
OpenAlex
W4206239577
Cited by
1,883
References
10
FWCI
141.20
Type
journal article
Language
en
Open access
bronze
Licence
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Funders
Bristol-Myers Squibb

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.