Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster viewing 06

400P - Phase I study of fianlimab, a human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, in combination with cemiplimab in advanced melanoma (mel)


03 Dec 2022


Poster viewing 06


Tumour Site



Omid Hamid


Annals of Oncology (2022) 33 (suppl_9): S1598-S1618. 10.1016/annonc/annonc1135


O. Hamid1, A. Weise2, T.M. Kim3, M. Mckean4, N. Lakhani5, J.P. Crown6, J. Kaczmar7, K. Papadopoulos8, S. Chen9, J. Mani9, V. Jankovic9, G. Kroog9, T. Sims9, I. Lowy9, G. Gullo9

Author affiliations

  • 1 Hematology And Oncology, The Angeles Clinical and Research Institute, a Cedars-Sinai Affiliate, 90025 - Los Angeles/US
  • 2 Medical Oncology, Henry Ford Hospital, 48202 - Detroit/US
  • 3 Hemato Oncology, Seoul National University Hospital, 03080 - Seoul/KR
  • 4 Medical Oncology, Sarah Cannon Research Institute/Tennessee Oncology PLLC, 37203 - Nashville/US
  • 5 Hematology And Oncology, START Midwest, MI 49546 - Grand Rapids/US
  • 6 Department Of Medical Oncology, St Vincent's University Hospital, D04 T6F4 - Dublin/IE
  • 7 Dept Of Medicine, MUSC Hollings Cancer Center, 29425 - Charleston/US
  • 8 Medical Oncology, START San Antonio, 78229 - San Antonio/US
  • 9 Clinical Sciences, Regeneron Pharmaceuticals, Inc., 10591 - Tarrytown/US

Abstract 400P


Concurrent blockade of LAG-3 may enhance efficacy of anti-programmed cell death-1 (PD-1) therapies. We present updated safety and clinical activity data from patients (pts) with advanced mel treated with concurrent anti-LAG-3 (fianlimab) and anti-PD-1 (cemiplimab).


This Phase 1 study included pts with unresectable or metastatic mel (excluding uveal mel) who were anti–PD-ligand (L)1 treatment naïve (expansion cohort [EC] 6) or anti–PD-(L) 1 experienced within 3 months of screening (EC7). Pts received fianlimab 1600 mg + cemiplimab 350 mg intravenously every 3 weeks for 12 months (optional extra 12 months if clinically indicated). Tumour measurements were taken every 6 weeks for 24 weeks, then every 9 weeks.


As of the 9 Feb 2022 data cutoff date, 40 EC6 and 15 EC7 pts were enrolled and treated with fianlimab + cemiplimab. For EC6 and EC7 cohorts respectively, median age was 69.5 and 59.0 years, 62.5% and 46.7% were male, 90.0% and 60.0% were White. Median treatment duration was 37.1 weeks (EC6) and 9.0 weeks (EC7). Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 37.5% (EC6) and 46.7% (EC7) of pts; serious TEAEs occurred in 32.5% (EC6) and 33.3% (EC7) of pts; 17.5% (EC6) and 13.3% (EC7) of pts discontinued treatment due to a TEAE. Rate of adrenal insufficiency was 12.5% (EC6) and 6.7% (EC7); none led to treatment discontinuation. Investigator-assessed objective response rate was 62.5% (6 complete responses; 19 partial responses [PRs]) in EC6 and 13.3% (2 PRs) in EC7 pts. Kaplan-Meier estimation of median progression-free survival was 14.2 (95% CI: 5.6–not estimated) months in EC6 and 1.4 (95% CI: 1.3–7.7) months in EC7 pts. Median duration of response had not been reached in both cohorts. LAG-3 and PD-L1 correlative biomarkers analysis will be included in the presentation.


Fianlimab + cemiplimab in advanced mel pts had a similar safety profile to anti–PD-1 agents; clinical activity in anti-PD-(L)1-naïve pts appears higher than previously reported for anti-PD-1 monotherapy or anti–LAG-3 + anti–PD-1. A phase 3 trial (NCT05352672) investigating fianlimab + cemiplimab in advanced mel pts is ongoing.

Clinical trial identification


Editorial acknowledgement

Medical writing support and typesetting was provided by Jenna Lee of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc.

Legal entity responsible for the study

Regeneron Pharmaceuticals, Inc.


Regeneron Pharmaceuticals, Inc.


O. Hamid: Financial Interests, Personal, Advisory Role: Aduro Biotech, Akeso Biopharma, Amgen, Arcus Biosciences, Bioatla, Bristol Myers Squibb, CytomX Therapeutics, Exelixis, Genentech, GlaxoSmithKline, Idera, Immunocore, Incyte, Iovance Biotherapeutics, Merck, Merck Serono, Moderna Therapeutics, NextCure, No. T.M. Kim: Financial Interests, Personal, Advisory Role: AstraZeneca/MedImmune, BeiGene, Boryung, F. Hoffmann-La Roche Ltd./Genentech, Inc., Janssen, Novartis, Sanofi, Takeda, Yuhan; Financial Interests, Personal, Research Grant: AstraZeneca; Financial Interests, Personal, Other, uncompensated relationships: Bayer, Boryung, Novartis, Regeneron Pharmaceuticals, Inc., Roche/Genentech, and Sanofi. M. Mckean: Financial Interests, Institutional, Research Grant: Alpine Immune Sciences, Arcus Biosciences, Arvinas, Ascentage Pharma Group, Bayer, Bicycle Therapeutics, BioMed Valley Discoveries, BioNTech, Dragonfly Therapeutics, EMD Serono, Epizyme, Erasca, Exelixis, Foghorn Therapeutics, Genentech, Gilead Sciences, ; Financial Interests, Institutional, Advisory Role, payments to institution: Astellas Pharma, AstraZeneca, BicycleTX Limited, Castle Biosciences, Eisai, Ideaya Biosciences, iTeos, Moderna, Pfizer, Regeneron Pharmaceuticals, Inc. N. Lakhani: Financial Interests, Personal, Advisory Role: Innovent Biologics, Ikena, and S.K. Life Sciences; Financial Interests, Personal, Research Grant: Innovent Biologics, Alexo Therapeutics, Ascentage Pharma, Asana Biosciences, BeiGene, Constellation Pharmaceuticals, Alexion Pharmaceuticals, Cerulean Pharma, Forty Seven, Loxo, Macrogenics, Merck, Pfizer, Regeneron Pharmaceuticals, Inc., Apexian Pharmace. J. Kaczmar: Financial Interests, Personal, Advisory Role: Bicara Therapeutics, Rakuten Medical, and Regeneron Pharmaceuticals, Inc. K. Papadopoulos: Financial Interests, Personal, Advisory Role: Basilea and Turning Point Therapeutics; Financial Interests, Personal, Research Grant: 3D Medicines, AbbVie, ADC Therapeutics, Amgen, Anheart Therapeutics, Bayer, Calithera Biosciences, Daiichi Sankyo, EMD Serono, F-star, Incyte, Jounce Therapeutics, Lilly, Linnaeus Therapeutics, MabSpace Biosciences, MedImmune, Merck, Mersana, Mirati Thera. S. Chen, J. Mani, V. Jankovic, G. Kroog, G. Gullo: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. T. Sims: Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Full or part-time Employment, current employee of AbbVie; was employed by Regeneron at the time the research was conducted: AbbVie. I. Lowy: Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc., Sanofi, Genentech. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.