Saadettin Kilickap, Ana Baramidze, Ahmet Sezer, Mustafa Özgüroğlu, Mahmut Gumus, Igor Bondarenko, Miranda Gogishvili, Marina Nechaeva, Michael Schenker, Irfan Cicin, Ho Gwo Fuang, Yaroslav Kulyaba, Kasimova Zyuhal, Roxana-Ioana Scheusan, Marina Chiara Garassino, Yuntong Li, Cong Zhu, Manika Kaul, Javier Perez, Frank Seebach, Israel Lowy, Jean-Francois Pouliot, Eric Kim, Heather Magnan
{"title":"Cemiplimab单药用于PD-L1表达≥50%的晚期NSCLC患者的一线治疗：EMPOWER-Lung 1 的 5 年疗效。","authors":"Saadettin Kilickap, Ana Baramidze, Ahmet Sezer, Mustafa Özgüroğlu, Mahmut Gumus, Igor Bondarenko, Miranda Gogishvili, Marina Nechaeva, Michael Schenker, Irfan Cicin, Ho Gwo Fuang, Yaroslav Kulyaba, Kasimova Zyuhal, Roxana-Ioana Scheusan, Marina Chiara Garassino, Yuntong Li, Cong Zhu, Manika Kaul, Javier Perez, Frank Seebach, Israel Lowy, Jean-Francois Pouliot, Eric Kim, Heather Magnan","doi":"10.1016/j.jtho.2025.03.033","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Earlier results from the phase 3 EMPOWER-Lung 1 trial demonstrated significant survival benefits and a generally acceptable safety profile of first-line cemiplimab monotherapy versus chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) expression in ≥50% of tumor cells and no EGFR, ALK, or ROS1 aberrations. Here, we report the 5-year outcomes.</p><p><strong>Methods: </strong>Patients were randomized 1:1 to cemiplimab 350 mg intravenous every 3 weeks for 2 years or investigator's choice of chemotherapy. The primary endpoints were overall survival (OS) and progression-free survival (PFS).</p><p><strong>Results: </strong>A total of 712 patients were randomized to cemiplimab (n = 357) or chemotherapy (n = 355). 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 PD-L1 ≥50% (n = 565), median OS was 26.1 months for cemiplimab vs. 13.3 months for chemotherapy (hazard ratio [HR] 0.59, 95% confidence interval [CI]: 0.48-0.72); median PFS was 8.1 months versus 5.3 months (HR 0.50, 95% CI: 0.41-0.61); the objective response rate was 46.5% versus 20.6%. The 5-year OS probability was 29.0% for cemiplimab and 15.0% for chemotherapy. Improved survival outcomes were observed with both squamous and non-squamous 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 treatment-related adverse events occurred in 18.3% of patients for cemiplimab and 39.9% for chemotherapy.</p><p><strong>Conclusions: </strong>At 5-year follow-up, first-line cemiplimab monotherapy continued to show durable clinical benefits versus chemotherapy in patients with advanced NSCLC with PD-L1 ≥50%. Patients with PD-L1 ≥90% derived the largest clinical benefits.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0000,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Cemiplimab Monotherapy for First-Line Treatment of Patients with Advanced NSCLC with PD-L1 Expression ≥50%: 5-Year Outcomes of EMPOWER-Lung 1.\",\"authors\":\"Saadettin Kilickap, Ana Baramidze, Ahmet Sezer, Mustafa Özgüroğlu, Mahmut Gumus, Igor Bondarenko, Miranda Gogishvili, Marina Nechaeva, Michael Schenker, Irfan Cicin, Ho Gwo Fuang, Yaroslav Kulyaba, Kasimova Zyuhal, Roxana-Ioana Scheusan, Marina Chiara Garassino, Yuntong Li, Cong Zhu, Manika Kaul, Javier Perez, Frank Seebach, Israel Lowy, Jean-Francois Pouliot, Eric Kim, Heather Magnan\",\"doi\":\"10.1016/j.jtho.2025.03.033\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Earlier results from the phase 3 EMPOWER-Lung 1 trial demonstrated significant survival benefits and a generally acceptable safety profile of first-line cemiplimab monotherapy versus chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) expression in ≥50% of tumor cells and no EGFR, ALK, or ROS1 aberrations. Here, we report the 5-year outcomes.</p><p><strong>Methods: </strong>Patients were randomized 1:1 to cemiplimab 350 mg intravenous every 3 weeks for 2 years or investigator's choice of chemotherapy. The primary endpoints were overall survival (OS) and progression-free survival (PFS).</p><p><strong>Results: </strong>A total of 712 patients were randomized to cemiplimab (n = 357) or chemotherapy (n = 355). 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 PD-L1 ≥50% (n = 565), median OS was 26.1 months for cemiplimab vs. 13.3 months for chemotherapy (hazard ratio [HR] 0.59, 95% confidence interval [CI]: 0.48-0.72); median PFS was 8.1 months versus 5.3 months (HR 0.50, 95% CI: 0.41-0.61); the objective response rate was 46.5% versus 20.6%. The 5-year OS probability was 29.0% for cemiplimab and 15.0% for chemotherapy. Improved survival outcomes were observed with both squamous and non-squamous 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 treatment-related adverse events occurred in 18.3% of patients for cemiplimab and 39.9% for chemotherapy.</p><p><strong>Conclusions: </strong>At 5-year follow-up, first-line cemiplimab monotherapy continued to show durable clinical benefits versus chemotherapy in patients with advanced NSCLC with PD-L1 ≥50%. 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Cemiplimab Monotherapy for First-Line Treatment of Patients with Advanced NSCLC with PD-L1 Expression ≥50%: 5-Year Outcomes of EMPOWER-Lung 1.
Introduction: Earlier results from the phase 3 EMPOWER-Lung 1 trial demonstrated significant survival benefits and a generally acceptable safety profile of first-line cemiplimab monotherapy versus chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) expression in ≥50% of tumor cells and no EGFR, ALK, or ROS1 aberrations. Here, we report the 5-year outcomes.
Methods: Patients were randomized 1:1 to cemiplimab 350 mg intravenous every 3 weeks for 2 years or investigator's choice of chemotherapy. The primary endpoints were overall survival (OS) and progression-free survival (PFS).
Results: A total of 712 patients were randomized to cemiplimab (n = 357) or chemotherapy (n = 355). 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 PD-L1 ≥50% (n = 565), median OS was 26.1 months for cemiplimab vs. 13.3 months for chemotherapy (hazard ratio [HR] 0.59, 95% confidence interval [CI]: 0.48-0.72); median PFS was 8.1 months versus 5.3 months (HR 0.50, 95% CI: 0.41-0.61); the objective response rate was 46.5% versus 20.6%. The 5-year OS probability was 29.0% for cemiplimab and 15.0% for chemotherapy. Improved survival outcomes were observed with both squamous and non-squamous 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 treatment-related adverse events occurred in 18.3% of patients for cemiplimab and 39.9% for chemotherapy.
Conclusions: At 5-year follow-up, first-line cemiplimab monotherapy continued to show durable clinical benefits versus chemotherapy in patients with advanced NSCLC with PD-L1 ≥50%. Patients with PD-L1 ≥90% derived the largest clinical benefits.
期刊介绍：
Journal of Thoracic Oncology (JTO), the official journal of the International Association for the Study of Lung Cancer,is the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies.The readship includes epidemiologists, medical oncologists, radiation oncologists, thoracic surgeons, pulmonologists, radiologists, pathologists, nuclear medicine physicians, and research scientists with a special interest in thoracic oncology.
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