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8 april 2026: Bron: Journal of thoracic oncology d.d. juli 2025

Immuuntherapie met Cemiplimab (Libtayo) gegeven als eerstelijns behandeling bij patiënten met bij de eerste diagnose al gevorderde uitgezaaide niet-kleincellige longkanker en met een PD-L1 expressie van 50 procent of meer verbeterde de overleving en responspercentages in vergelijking met chemotherapie.
Uit de resultaten van de fase III EMPOWER-Lung 1-studie blijkt 23% van de patiënten na zes jaar nog in leven. Ook de ziekteprogressie resultaten verbeterden met Cemiplimab (Libtayo), waaronder een mediane ziekteprogressievrije overleving  van 8 versus 5 maanden en een risicovermindering van ongeveer 49% op ziekteprogressie.

De 6-jaars overleving liet als mediane algehele overleving een verschil zien van 26 maanden versus 13 maanden voor de chemotherapie.

Belangrijkste conclusies:

  • Cemiplimab (Libtayo) verminderde het risico op overlijden met ongeveer 40% ten opzichte van chemotherapie, wat resulteerde in een mediane verbetering van de algehele overleving (OS) van 13 maanden en een 6-jaarsoverlevingskans van 23% versus 13% voor chemotherapiegroep.
  • De progressie-uitkomsten verbeterden met Cemiplimab (Libtayo), waaronder een mediane ziekteprogressievrije overleving  van 8 versus 5 maanden en een risico vermindering van ongeveer 49% op ziekteprogressie.
  • Objectieve responsen kwamen vaker voor met Cemiplimab (Libtayo) (46%) dan met chemotherapie (21%), wat de chemotherapie besparende eerstelijnsbehandeling voor PD-L1 met hoge expressie als onnodig bevestigt.
  • Het klinische voordeel strekte zich uit over de PD-L1-subgroepen van 50%-60%, 60%-90% en ≥90%, met het grootste voordeel bij tumoren met een PD-L1-expressie van ≥90%.
  • De verdraagbaarheid was ook beter bij Cemiplimab (Libtayo), met ernstige bijwerkingen graad ≥3 van 45% versus 51%, het meest voorkomend waren bloedarmoede, longontsteking en vermoeidheid.

Hier een grafiek met de resultaten uit het studierapport:




Dr. Miranda Gogishvili
, medisch oncoloog bij het High Technology Medical Center, Universiteitskliniek in Tbilisi, Georgië, zei dat de zesjarige follow-up een mediane algehele overleving van 26 maanden liet zien met Cemiplimab (Libtayo) versus 13 maanden met chemotherapie, samen met een verbeterde ziekteprogressievrije overleving en een responspercentage van 46% vergeleken met 21%.
Ze merkte op dat patiënten met een PD-L1-expressie van 50% of meer in alle subgroepen baat hadden bij de behandeling, waarbij het grootste voordeel werd gezien bij patiënten met een PD-L1-expressie van 90% of hoger.
Cemiplimab (Libtayo) vertoonde ook een gunstiger veiligheidsprofiel, met minder behandelingsgerelateerde bijwerkingen van graad 3 of hoger dan chemotherapie, waarvan de meest voorkomende bloedarmoede, longontsteking en vermoeidheid waren.

Het volledige studierapport is gratis in te zien of te downloaden. Klik daarvoor op de titel van het abstract:

Original ArticleVolume 20Issue 7p941-954July 2025Open access

Cemiplimab Monotherapy for First-Line Treatment of Patients with Advanced NSCLC With PD-L1 Expression of 50% or Higher: Five-Year Outcomes of EMPOWER-Lung 1

Affiliations & Notes
Article Info
Publication History:
Received December 23, 2024Revised March 4, 2025Accepted March 14, 2025Published online March 18, 2025
Footnotes:
Cite this article as: Kilickap S, Baramidze A, Sezer A, et al. Cemiplimab monotherapy for first-line treatment of patients with advanced NSCLC with PD-L1 expression of 50% or higher: Five-year outcomes of EMPOWER-Lung 1. J Thorac Oncol. 2025;20:941-954.
Copyright: © 2025 The Authors. Published by Elsevier Inc. on behalf of International Association for the Study of Lung Cancer.
Linked Articles (1)
Cover Image - Journal of Thoracic Oncology, Volume 20, Issue 7

Abstract

Introduction

Earlier results from the phase 3 EMPOWER-Lung 1 trial indicated significant survival benefits and a generally acceptable safety profile of first-line cemiplimab monotherapy versus chemotherapy for patients with advanced NSCLC with programmed cell death-ligand 1 (PD-L1) expression in 50% or more tumor cells and no EGFRALK, or ROS1 aberrations. Here, we report the five-year outcomes.

Methods

Patients were randomized 1:1 to cemiplimab 350 mg intravenously every three weeks for two years or the investigator’s choice of chemotherapy. The primary endpoints were overall survival (OS) and progression-free survival.

Results

A total of 712 patients were randomized to cemiplimab (n = 357) or chemotherapy (n = 355). The median duration of follow-up was 59.6 months (interquartile range: 55.1–66.7 months) at the data cutoff (January 16, 2024). In patients with verified 50% or higher PD-L1 (n = 565), median OS was 26.1 months for cemiplimab versus 13.3 months for chemotherapy (hazard ratio = 0.59, 95% confidence interval : 0.48–0.72); the median progression-free survival was 8.1 months versus 5.3 months (hazard ratio = 0.50, 95% confidence interval: 0.41–0.61); and the objective response rate was 46.5% versus 20.6%. The five-year OS probability was 29.0% for cemiplimab and 15.0% for chemotherapy. Improved survival outcomes were observed with both squamous and nonsquamous histology, and increasing activity of cemiplimab was correlated with higher PD-L1 expression, with the highest PD-L1 expression having the best outcome. The safety profile remains consistent with previous results. Grade 3 or higher treatment-related adverse events occurred in 18.3% of patients for cemiplimab and 39.9% for chemotherapy.

Conclusions

At five-year follow-up, first-line cemiplimab monotherapy continued to show durable clinical benefits versus chemotherapy in patients with advanced NSCLC with 50% or higher PD-L1. Patients with 90% or higher PD-L1 derived the largest clinical benefits.

Figures (5)

CRediT Authorship Contribution Statement
Saadettin Kilickap: Investigation, Writing - review & editing.
Ana Baramidze: Investigation, Writing - review & editing.
Ahmet Sezer: Investigation, Writing - review & editing.
Mustafa Özgüroğlu: Investigation, Writing - review & editing.
Mahmut Gumus: Investigation, Writing - review & editing.
Igor Bondarenko: Investigation, Writing - review & editing.
Miranda Gogishvili: Investigation, Writing - review & editing.
Marina Nechaeva: Investigation, Writing - review & editing.
Michael Schenker: Investigation, Writing - review & editing.
Irfan Cicin: Investigation, Writing - review & editing.
Ho Gwo Fuang: Investigation, Writing - review & editing.
Yaroslav Kulyaba: Investigation, Writing - review & editing.
Kasimova Zyuhal: Investigation, Writing - review & editing.
Roxana-Ioana Scheusan: Investigation, Writing - review & editing.
Marina Chiara Garassino: Investigation, Writing - review & editing.
Yuntong Li: Formal analysis, Writing - review & editing.
Cong Zhu: Formal analysis, Writing - review & editing.
Manika Kaul: Formal analysis, Writing - review & editing.
Javier Perez: Formal analysis, Writing - review & editing.
Frank Seebach: Conceptualization, Methodology, Formal analysis, Writing - review & editing.
Israel Lowy: Conceptualization, Methodology, Formal analysis, Writing - review & editing.
Jean-Francois Pouliot: Methodology, Formal analysis, Writing - review & editing.
Eric Kim: Conceptualization, Methodology, Formal analysis, Writing - review & editing.
Heather Magnan: Conceptualization, Methodology, Formal analysis, Writing - review & editing.

Data Availability Statement

Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, and statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing if the following criteria are met: (1) once the product and indication have been approved by major health authorities (e.g., the Food and Drug Administration, European Medicines Agency, and Pharmaceuticals and Medical Devices Agency, etc.) or development of the product has been discontinued globally for all indications on or after April 2020 and there are no plans for future development; (2) if there is legal authority to share the data; and (3) there is not a reasonable likelihood of participant reidentification. Submit requests to https://vivli.org/.

Disclosure

Dr. Kilickap reports receiving meeting and travel support from Regeneron Pharmaceuticals, Inc. Dr. Özgüroğlu reports advisory board participation for Sanofi and Regeneron Pharmaceuticals, Inc.; and receiving travel and accommodation support from Regeneron Pharmaceuticals. Dr. Gümüş reports honoraria to institution for lectures from Roche, Merck Sharp & Dohme, Gen İlaç, and Novartis outside the submitted work. Dr. Schenker reports research grants from Regeneron Pharmaceuticals, Inc., Bristol Myers Squibb, MSD, Roche, Merck Serono, AstraZeneca, Eli Lilly, Astellas, Amgen, BeiGene, Bayer, Eisai, Pfizer, GSK, AbbVie, Bioven, Novartis, Clovis, Daichii Sankyo, PharmaMar, Tesaro, and Five Prime Therapeutics. Dr. Ho reports institutional grants from Regeneron Pharmaceuticals, Inc., MSD, AB Science, Astellas, Tessa Therapeutics, Roche, Arcus Bioscience, AstraZeneca, Pfizer, Janssen Research & Development, Mirati Therapeutics, Novartis, Amgen, and Boehringer Ingelheim; honoraria from MSD, Novartis, F. Hoffmann-La Roche AG, AstraZeneca, Boehringer Ingelheim, Pfizer, Merck & Co., Inc., and Eisai; meeting and travel support from Ipsen, AstraZeneca, Bristol Myers Squibb, MSD, Regeneron Pharmaceuticals, Inc., Dr. Reddy’s Laboratories, Roche, Servier, Zullig Pharma, and Pfizer; data safety monitoring or advisory board participation for MSD, Novartis, Roche, AstraZeneca, Boehringer Ingelheim, Pfizer, Astellas Pharma, Inc., and Takeda Pharmaceuticals; and institutional receipt of equipment, materials, drugs, medical writing, gifts, or other services from Pfizer, Novartis, Janssen Pharmaceuticals, Taiho, and Eli Lilly. Dr. Garassino reports grants from Merck; consulting fees from AstraZeneca, MSD International GmbH, Bristo Myers Squibb, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Roche, Takeda, Seattle Genetics, Mirati, Daiichi Sankyo, Regeneron Pharmaceuticals, Inc., Merck, Pfizer (MISP), Celgene, Tiziana, Foundation Medicine, GSK, Spectrum Pharmaceuticals, AIRC, AIFA, the Italian Ministry of Health, and TRANSCAN; honoraria from AstraZeneca, MSD International GmbH, Bristol Myers Squibb, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Roche, Takeda, Seattle Genetics, Mirati, Daiichi Sankyo, Regeneron Pharmaceuticals, Inc., Merck, Pfizer (MISP), Tiziana, Foundation Medicine, GSK, Spectrum Pharmaceuticals, AIRC, AIFA, the Italian Ministry of Health, and TRANSCAN; meeting and travel support from Merck; and data safety monitoring or advisory board participation for Eli Lilly, Pfizer (MISP), AstraZeneca, MSD International GmbH, Bristol Myers Squibb, Boehringer Ingelheim Italia S.p.A, Celgene, Ignyta, Incyte, MedImmune, Novartis, Roche, Takeda, Tiziana, Foundation Medicine, GSK, Spectrum Pharmaceuticals, AIRC, AIFA, the Italian Ministry of Health, and TRANSCAN. Drs. Li, Zhu, Kaul, Perez, Seebach, Lowy, Pouliot, Kim, and Magnan are employees of Regeneron Pharmaceuticals, Inc. and own stock or stock options. The remaining authors declare no conflict of interest.

Acknowledgments

This work was supported by Regeneron Pharmaceuticals, Inc. and Sanofi. The authors thank the patients, their families, all other investigators, and all investigational site members involved in this study. Medical writing support under the direction of the authors was provided by Anil Sindhurakar, PhD, and Qing Zhou, PhD, ELS, of Regeneron Pharmaceuticals, Inc. Editorial and figure support was provided by Elke Sims, MLangTrans, and Deb Cantu, PhD, both of Alpha (a division of Prime, Knutsford, United Kingdom) and funded by Regeneron Pharmaceuticals, Inc. The sponsor was involved in the study design, data collection, analysis, interpretation, and data checking of results described in the manuscript. The authors had unrestricted access to study data, were responsible for all content and editorial decisions, and received no honoraria related to the development of this publication.

Supplementary Data (1)

Supplementary Tables 1-4 and Supplementary Figure 1 and 2

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