Skip to main content
Log in

Nivolumab Plus Relatlimab: First Approval

  • AdisInsight Report
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Nivolumab plus relatlimab (nivolumab and relatlimab-rmbw; Opdualag) is a fixed-dose, combination immunotherapy treatment being developed by Bristol Myers Squibb for the treatment of multiple types of advanced cancers. Both drugs are immunoglobulin G4 (IgG4) monoclonal antibodies developed to target immune checkpoints, with nivolumab targeting the programmed cell death protein 1 (PD-1) receptor and relatlimab being a newly developed, first-in-class drug targeting the lymphocyte-activation gene 3 (LAG-3) protein. In March 2022, nivolumab plus relatlimab received its first approval in the USA for the treatment of unresectable or metastatic melanoma in adult patients and paediatric patients aged ≥ 12 years who weigh ≥ 40 kg. This article summarizes the milestones in the development of this combination therapy leading to this first approval for unresectable or metastatic melanoma.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Bristol-Myers Squibb. OPDUALAG (nivolumab and relatlimab-rmbw) injection, for intravenous use: US prescribing information. 2022. https://www.accessdata.fda.gov/. Accessed 26 Apr 2022.

  2. Shi AP, Tang XY, Xiong YL, et al. Immune checkpoint LAG3 and its ligand FGL1 in cancer. Front Immunol. 2022;12(785091):1–11.

    Google Scholar 

  3. LaFleur MW, Muroyama Y, Drake CG, et al. Inhibitors of the PD-1 pathway in tumor therapy. J Immunol. 2018;200(2):375–83.

    Article  CAS  Google Scholar 

  4. Barbari C, Fontaine T, Parajuli P, et al. Immunotherapies and combination strategies for immuno-oncology. Int J Mol Sci. 2020;21(14):5009.

    Article  CAS  Google Scholar 

  5. Wei SC, Duffy CR, Allison JP. Fundamental mechanisms of immune checkpoint blockade therapy. Cancer Discov. 2018;8(9):1069–86.

    Article  Google Scholar 

  6. US Food & Drug Administration. FDA approves Opdualag for unresectable or metastatic melanoma [media release]. 18 Mar 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-opdualag-unresectable-or-metastatic-melanoma.

  7. Bristol-Myers Squibb. Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. announce strategic immuno-oncology collaboration in Japan, South Korea and Taiwan [media release]. 23 Jul 2014. http://www.bms.com.

  8. Halozyme Therapeutics, Bristol-Myers Squibb. Bristol-Myers Squibb and Halozyme enter global collaboration and license agreement for ENHANZE® technology [media release]. 14 Sep 2017. http://www.halozyme.com.

  9. Halozyme Therapeutics Inc. Annual report on Form 10-K. 2020. https://www.sec.gov/. Accessed 26 Apr 2022.

  10. Sordo-Bahamonde C, Lorenzo-Herrero S, González-Rodríguez AP, et al. LAG-3 blockade with relatlimab (BMS-986016) restores anti-leukemic responses in chronic lymphocytic leukemia. Cancers (Basel). 2021;13(9):2122.

    Article  Google Scholar 

  11. Thudium K, Selby M, Zorn JA, et al. Preclinical characterization of relatlimab, a human LAG-3-blocking antibody, alone or in combination with nivolumab. bioRxiv. 2022. https://doi.org/10.1101/2022.01.24.477551.

  12. Zhao Y, Hu Z, Suryawanshi R, et al. Model-informed clinical pharmacology (CP) profile of a novel fixed-dose combination (FDC) of relatlimab and nivolumab in patients with solid tumors. Clin Pharmacol Ther. 2022;111(Suppl. 1):S61.

    Google Scholar 

  13. Tawbi HA, Schadendorf D, Lipson EJ, et al. Relatlimab and nivolumab versus nivolumab in untreated advanced melanoma. N Engl J Med. 2022;386(1):24–34.

    Article  CAS  Google Scholar 

  14. Long GV, Hodi FS, Lipson EJ, et al. Relatlimab and nivolumab versus nivolumab in previously untreated metastatic or unresectable melanoma: overall survival and response rates from RELATIVITY-047 (CA224-047). J Clin Oncol. 2022;40(36 Suppl.): 360385.

    Article  Google Scholar 

  15. Ascierto PA, Bono P, Bhatia S, et al. Efficacy of BMS-986016, a monoclonal antibody that targets lymphocyte activation gene-3 (LAG-3), in combination with nivolumab in pts with melanoma who progressed during prior anti-PD-1/PD-L1 therapy (mel prior IO) in all-comer and biomarkerenriched populations. Ann Oncol. 2017;28(Suppl 5):v611–2.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Julia Paik.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Julia Paik is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability

Not applicable.

Additional information

This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PPTX 502 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Paik, J. Nivolumab Plus Relatlimab: First Approval. Drugs 82, 925–931 (2022). https://doi.org/10.1007/s40265-022-01723-1

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-022-01723-1

Navigation