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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

2873 - Cemiplimab, a human monoclonal anti-PD-1, plus radiotherapy (RT) in advanced non-small-cell lung cancer (NSCLC): Results from a Phase 1 expansion cohort (EC 2)


20 Oct 2018


Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research


Clinical Research

Tumour Site


Victor Moreno


Annals of Oncology (2018) 29 (suppl_8): viii400-viii441. 10.1093/annonc/mdy288


V. Moreno1, M. Gil-Martin2, M. Johnson3, R. Aljumaily4, P. Lopez Criado5, D.W. Northfelt6, M. Crittenden7, S. Jabbour8, L. Rosen9, P. Garrido Lopez10, A. Hervás Morón11, P. Rietschel12, K.K. Mohan12, J. Li13, E. Stankevich14, T. Rowlands12, M. Feng14, I. Lowy12, M.G. Fury12

Author affiliations

  • 1 Phase 1 Trials Unit, START Madrid-FJD, Hospital Fundación Jiménez Díaz, 28040 - Madrid/ES
  • 2 L’hospitalet De Llobregat, Institut Català d’Oncologia, 08908 - Barcelona/ES
  • 3 Department Of Medical Oncology, Sarah Cannon Research Institute, Nashville/US
  • 4 Department Of Hematology/oncology, Oklahoma University Medical Center, Oklahoma City/US
  • 5 Department Of Medical Oncology, MD Anderson Cancer Center, Madrid/ES
  • 6 Department Of Internal Medicine, Division Of Hematology/oncology, Mayo Clinic, Phoenix/US
  • 7 Robert W. Franz Cancer Center, Providence Portland Medical Center And The Oregon Clinic, Earle A. Chiles Research Institute, 97213 - Portland/US
  • 8 Department Of Radiation oncology, Rutgers Cancer Institute of New Jersey, New Brunswick/US
  • 9 Division Of Hematology-oncology, UCLA, Los Angeles/US
  • 10 Medical Oncology Department, Hospital Universitario Ramon y Cajal, 28031 - Madrid/ES
  • 11 Department Of Radiology, Hospital Universitario Ramón y Cajal, Madrid/ES
  • 12 Clinical Sciences, Regeneron Pharmaceuticals, Inc., Tarrytown/US
  • 13 Biostatistics & Data Management, Regeneron Pharmaceuticals, Inc., 07920 - Basking Ridge/US
  • 14 Clinical Sciences, Regeneron Pharmaceuticals, Inc., 07920 - Basking Ridge/US


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Abstract 2873


Cemiplimab (REGN2810), a human monoclonal antibody to PD-1, has exhibited substantial antitumour activities in patients (pts) with advanced malignancies in a Phase 1 study. Most patients with advanced NSCLC do not respond to PD-1 inhibitor monotherapy. Here we report results of the Phase 1 EC 2, a combination regimen of cemiplimab plus RT in advanced NSCLC (NCT02383212).


Pts with advanced NSCLC who had relapsed after or were refractory to at least first-line therapy and for whom palliative RT was clinically indicated, received cemiplimab 3 mg/kg every 2 weeks for up to 48 weeks plus RT (9 Gy × 3 times/week given 1 week after first dose of cemiplimab) to a single lesion. The co-primary objectives were to evaluate the safety, tolerability, and efficacy of cemiplimab plus RT. Tumour measurements (of non-irradiated target lesions) were performed by RECIST 1.1 every 8 weeks.


As of 1 Sept, 2017, 33 pts (22 M/ 11 F; median age 67.0 years [range, 47–82]) were enrolled; 66.7% and 30.3% had an ECOG performance status of 1 and 0, respectively; the status of one pt was unknown. Overall response rate (ORR; complete response [CR] + partial response [PR]) was 18.2% (0 CR and 6 PRs) with a median duration of response of 14.9 months (95% CI: 5.5–14.9). Disease control rate (ORR + stable disease [SD]) was 72.7% (6 PRs + 18 SDs). The most common treatment-emergent adverse events (TEAEs) of any grade were decreased appetite (30.3%), fatigue (27.3%), and cough (24.2%). Grade ≥3 TEAEs occurring in ≥ 2 patients include anaemia (12.1%), hypophosphataemia, and urinary tract infection (each 6.1%). One patient had a TEAE of pneumonitis, considered related to study drug, with an outcome of death.


Cemiplimab plus RT demonstrated antitumour activity in pretreated pts with NSCLC. The safety profile is comparable with other anti-PD-1 agents and RT. The combination therapy regimen did not produce greater efficacy above that which can be achieved with PD-1 inhibitor monotherapy for advanced NSCLC.

Clinical trial identification


Legal entity responsible for the study

Regeneron Pharmaceutical Inc.; Sanofi.


Regeneron Pharmaceutical Inc.; Sanofi.

Editorial Acknowledgement

Medical writing support under the direction of the authors was provided by Emmanuel Ogunnowo, PhD, of Prime (Knutsford, UK) and funded by Regeneron Pharmaceuticals, Inc. and Sanofi according to Good Publication Practice guidelines (http://annals.org/aim/article/2424869/good-publication-practice-communicating-company-sponsored-medical-research-gpp3).


M. Johnson: Consulting or advisory role: Astellas Pharma, Otsuka. M. Crittenden: Research funding: Jounce, Nanobiotix. S. Jabbour: Research funding grants: Merck, Nestle, outside the submitted work. L. Rosen: Research funding: Regeneron Pharmaceuticals, Inc. P. Garrido: Personal fees: Roche, BMS, MSD, Pfizer, Lilly, Abbvie, Regeneron, AstraZeneca, Novartis, Boerinhger-Ingelheim, outside the submitted work. P. Rietschel: Shareholder and an employee of, and has received honoraria: Regeneron Pharmaceuticals, Inc. K.K. Mohan, J. Li, T. Rowlands: Shareholder and employee of Regeneron Pharmaceuticals, Inc. E. Stankevich: Shareholder and employee: Regeneron Pharmaceuticals, Inc.; Shareholder: Celgene, Bristol-Myers Squibb, Merck. M. Feng: Shareholder and employee: Regeneron Pharmaceuticals, Inc.; Shareholder: Bayer. I. Lowy: Shareholder and employee of, and gained fees for travel and accommodation expenses as well as leadership: Regeneron Pharmaceuticals, Inc. M.G. Fury: Shareholder and an employee of, and holds patents, royalties, other intellectual property: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.

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