Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial

Tamta Makharadze; Miranda Gogishvili; Tamar Melkadze; Ana Baramidze; Davit Giorgadze; Konstantin Penkov; Konstantin Laktionov; Gia Nemsadze; Marina Nechaeva; Irina Rozhkova; Ewa Kalinka; Siyu Li; Yuntong Li; Manika Kaul; Ruben G.W. Quek; Jean Francois Pouliot; Frank Seebach; Israel Lowy; Giuseppe Gullo; Petra Rietschel

doi:10.1016/j.jtho.2023.03.008

Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial

Tamta Makharadze, Miranda Gogishvili, Tamar Melkadze, Ana Baramidze, Davit Giorgadze, Konstantin Penkov, Konstantin Laktionov, Gia Nemsadze, Marina Nechaeva, Irina Rozhkova, Ewa Kalinka, Siyu Li, Yuntong Li, Manika Kaul, Ruben G.W. Quek, Jean Francois Pouliot, Frank Seebach, Israel Lowy, Giuseppe Gullo, Petra Rietschel

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Abstract

Introduction: EMPOWER-Lung 3 part 2 (NCT03409614), a double-blind, placebo-controlled phase 3 study, investigated cemiplimab (antiprogrammed cell death protein 1) plus chemotherapy versus placebo plus chemotherapy in patients with advanced NSCLC without EGFR, ALK, or ROS1 aberrations, with either squamous or nonsquamous histology, irrespective of programmed death-ligand 1 levels. At primary analysis, after 16.4 months of follow-up, cemiplimab plus chemotherapy improved median overall survival (OS) versus chemotherapy alone (21.9 versus 13.0 mo, hazard ratio [HR] = 0.71, 95% confidence interval [CI]: 0.53–0.93, p = 0.014). Here, we report protocol-specified final OS and 2-year follow-up results. Methods: Patients (N = 466) were randomized 2:1 to receive histology-specific platinum-doublet chemotherapy, with 350 mg cemiplimab (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks. Primary end point was OS; secondary end points included progression-free survival and objective response rates. Results: After 28.4 months of median follow-up, median OS was 21.1 months (95% CI: 15.9–23.5) for cemiplimab plus chemotherapy versus 12.9 months (95% CI: 10.6–15.7) for chemotherapy alone (HR = 0.65, 95% CI: 0.51–0.82, p = 0.0003); median progression-free survival was 8.2 months (95% CI: 6.4–9.0) versus 5.5 months (95% CI: 4.3–6.2) (HR = 0.55, 95% CI: 0.44–0.68, p < 0.0001), and objective response rates were 43.6% versus 22.1%, respectively. Safety was generally consistent with previously reported data. Incidence of treatment-emergent adverse events of grade 3 or higher was 48.7% with cemiplimab plus chemotherapy and 32.7% with chemotherapy alone. Conclusions: At protocol-specified final OS analysis with 28.4 months of follow-up, the EMPOWER-Lung 3 study continued to reveal benefit of cemiplimab plus chemotherapy versus chemotherapy alone in patients with advanced squamous or nonsquamous NSCLC, across programmed death-ligand 1 levels.

Original language	English
Pages (from-to)	755-768
Number of pages	14
Journal	Journal of Thoracic Oncology
Volume	18
Issue number	6
DOIs	https://doi.org/10.1016/j.jtho.2023.03.008
State	Published - Jun 2023
Externally published	Yes

Keywords

Advanced non–small cell lung cancer
Cemiplimab
Immunotherapy
PD-1
PD-L1

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10.1016/j.jtho.2023.03.008

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Makharadze, T., Gogishvili, M., Melkadze, T., Baramidze, A., Giorgadze, D., Penkov, K., Laktionov, K., Nemsadze, G., Nechaeva, M., Rozhkova, I., Kalinka, E., Li, S., Li, Y., Kaul, M., Quek, R. G. W., Pouliot, J. F., Seebach, F., Lowy, I., Gullo, G., & Rietschel, P. (2023). Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial. Journal of Thoracic Oncology, 18(6), 755-768. https://doi.org/10.1016/j.jtho.2023.03.008

@article{ee6501e1528a4d4089ff488848f1c2f7,

title = "Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial",

abstract = "Introduction: EMPOWER-Lung 3 part 2 (NCT03409614), a double-blind, placebo-controlled phase 3 study, investigated cemiplimab (antiprogrammed cell death protein 1) plus chemotherapy versus placebo plus chemotherapy in patients with advanced NSCLC without EGFR, ALK, or ROS1 aberrations, with either squamous or nonsquamous histology, irrespective of programmed death-ligand 1 levels. At primary analysis, after 16.4 months of follow-up, cemiplimab plus chemotherapy improved median overall survival (OS) versus chemotherapy alone (21.9 versus 13.0 mo, hazard ratio [HR] = 0.71, 95% confidence interval [CI]: 0.53–0.93, p = 0.014). Here, we report protocol-specified final OS and 2-year follow-up results. Methods: Patients (N = 466) were randomized 2:1 to receive histology-specific platinum-doublet chemotherapy, with 350 mg cemiplimab (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks. Primary end point was OS; secondary end points included progression-free survival and objective response rates. Results: After 28.4 months of median follow-up, median OS was 21.1 months (95% CI: 15.9–23.5) for cemiplimab plus chemotherapy versus 12.9 months (95% CI: 10.6–15.7) for chemotherapy alone (HR = 0.65, 95% CI: 0.51–0.82, p = 0.0003); median progression-free survival was 8.2 months (95% CI: 6.4–9.0) versus 5.5 months (95% CI: 4.3–6.2) (HR = 0.55, 95% CI: 0.44–0.68, p < 0.0001), and objective response rates were 43.6% versus 22.1%, respectively. Safety was generally consistent with previously reported data. Incidence of treatment-emergent adverse events of grade 3 or higher was 48.7% with cemiplimab plus chemotherapy and 32.7% with chemotherapy alone. Conclusions: At protocol-specified final OS analysis with 28.4 months of follow-up, the EMPOWER-Lung 3 study continued to reveal benefit of cemiplimab plus chemotherapy versus chemotherapy alone in patients with advanced squamous or nonsquamous NSCLC, across programmed death-ligand 1 levels.",

keywords = "Advanced non–small cell lung cancer, Cemiplimab, Immunotherapy, PD-1, PD-L1",

author = "Tamta Makharadze and Miranda Gogishvili and Tamar Melkadze and Ana Baramidze and Davit Giorgadze and Konstantin Penkov and Konstantin Laktionov and Gia Nemsadze and Marina Nechaeva and Irina Rozhkova and Ewa Kalinka and Siyu Li and Yuntong Li and Manika Kaul and Quek, {Ruben G.W.} and Pouliot, {Jean Francois} and Frank Seebach and Israel Lowy and Giuseppe Gullo and Petra Rietschel",

note = "Publisher Copyright: {\textcopyright} 2023",

year = "2023",

month = jun,

doi = "10.1016/j.jtho.2023.03.008",

language = "English",

volume = "18",

pages = "755--768",

journal = "Journal of Thoracic Oncology",

issn = "1556-0864",

publisher = "Elsevier Inc.",

number = "6",

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Makharadze, T, Gogishvili, M, Melkadze, T, Baramidze, A, Giorgadze, D, Penkov, K, Laktionov, K, Nemsadze, G, Nechaeva, M, Rozhkova, I, Kalinka, E, Li, S, Li, Y, Kaul, M, Quek, RGW, Pouliot, JF, Seebach, F, Lowy, I, Gullo, G & Rietschel, P 2023, 'Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial', Journal of Thoracic Oncology, vol. 18, no. 6, pp. 755-768. https://doi.org/10.1016/j.jtho.2023.03.008

TY - JOUR

T1 - Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC

T2 - 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial

AU - Makharadze, Tamta

AU - Gogishvili, Miranda

AU - Melkadze, Tamar

AU - Baramidze, Ana

AU - Giorgadze, Davit

AU - Penkov, Konstantin

AU - Laktionov, Konstantin

AU - Nemsadze, Gia

AU - Nechaeva, Marina

AU - Rozhkova, Irina

AU - Kalinka, Ewa

AU - Li, Siyu

AU - Li, Yuntong

AU - Kaul, Manika

AU - Quek, Ruben G.W.

AU - Pouliot, Jean Francois

AU - Seebach, Frank

AU - Lowy, Israel

AU - Gullo, Giuseppe

AU - Rietschel, Petra

PY - 2023/6

Y1 - 2023/6

N2 - Introduction: EMPOWER-Lung 3 part 2 (NCT03409614), a double-blind, placebo-controlled phase 3 study, investigated cemiplimab (antiprogrammed cell death protein 1) plus chemotherapy versus placebo plus chemotherapy in patients with advanced NSCLC without EGFR, ALK, or ROS1 aberrations, with either squamous or nonsquamous histology, irrespective of programmed death-ligand 1 levels. At primary analysis, after 16.4 months of follow-up, cemiplimab plus chemotherapy improved median overall survival (OS) versus chemotherapy alone (21.9 versus 13.0 mo, hazard ratio [HR] = 0.71, 95% confidence interval [CI]: 0.53–0.93, p = 0.014). Here, we report protocol-specified final OS and 2-year follow-up results. Methods: Patients (N = 466) were randomized 2:1 to receive histology-specific platinum-doublet chemotherapy, with 350 mg cemiplimab (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks. Primary end point was OS; secondary end points included progression-free survival and objective response rates. Results: After 28.4 months of median follow-up, median OS was 21.1 months (95% CI: 15.9–23.5) for cemiplimab plus chemotherapy versus 12.9 months (95% CI: 10.6–15.7) for chemotherapy alone (HR = 0.65, 95% CI: 0.51–0.82, p = 0.0003); median progression-free survival was 8.2 months (95% CI: 6.4–9.0) versus 5.5 months (95% CI: 4.3–6.2) (HR = 0.55, 95% CI: 0.44–0.68, p < 0.0001), and objective response rates were 43.6% versus 22.1%, respectively. Safety was generally consistent with previously reported data. Incidence of treatment-emergent adverse events of grade 3 or higher was 48.7% with cemiplimab plus chemotherapy and 32.7% with chemotherapy alone. Conclusions: At protocol-specified final OS analysis with 28.4 months of follow-up, the EMPOWER-Lung 3 study continued to reveal benefit of cemiplimab plus chemotherapy versus chemotherapy alone in patients with advanced squamous or nonsquamous NSCLC, across programmed death-ligand 1 levels.

AB - Introduction: EMPOWER-Lung 3 part 2 (NCT03409614), a double-blind, placebo-controlled phase 3 study, investigated cemiplimab (antiprogrammed cell death protein 1) plus chemotherapy versus placebo plus chemotherapy in patients with advanced NSCLC without EGFR, ALK, or ROS1 aberrations, with either squamous or nonsquamous histology, irrespective of programmed death-ligand 1 levels. At primary analysis, after 16.4 months of follow-up, cemiplimab plus chemotherapy improved median overall survival (OS) versus chemotherapy alone (21.9 versus 13.0 mo, hazard ratio [HR] = 0.71, 95% confidence interval [CI]: 0.53–0.93, p = 0.014). Here, we report protocol-specified final OS and 2-year follow-up results. Methods: Patients (N = 466) were randomized 2:1 to receive histology-specific platinum-doublet chemotherapy, with 350 mg cemiplimab (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks. Primary end point was OS; secondary end points included progression-free survival and objective response rates. Results: After 28.4 months of median follow-up, median OS was 21.1 months (95% CI: 15.9–23.5) for cemiplimab plus chemotherapy versus 12.9 months (95% CI: 10.6–15.7) for chemotherapy alone (HR = 0.65, 95% CI: 0.51–0.82, p = 0.0003); median progression-free survival was 8.2 months (95% CI: 6.4–9.0) versus 5.5 months (95% CI: 4.3–6.2) (HR = 0.55, 95% CI: 0.44–0.68, p < 0.0001), and objective response rates were 43.6% versus 22.1%, respectively. Safety was generally consistent with previously reported data. Incidence of treatment-emergent adverse events of grade 3 or higher was 48.7% with cemiplimab plus chemotherapy and 32.7% with chemotherapy alone. Conclusions: At protocol-specified final OS analysis with 28.4 months of follow-up, the EMPOWER-Lung 3 study continued to reveal benefit of cemiplimab plus chemotherapy versus chemotherapy alone in patients with advanced squamous or nonsquamous NSCLC, across programmed death-ligand 1 levels.

KW - Advanced non–small cell lung cancer

KW - Cemiplimab

KW - Immunotherapy

KW - PD-1

KW - PD-L1

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U2 - 10.1016/j.jtho.2023.03.008

DO - 10.1016/j.jtho.2023.03.008

M3 - Article

C2 - 37001859

AN - SCOPUS:85151453634

SN - 1556-0864

VL - 18

SP - 755

EP - 768

JO - Journal of Thoracic Oncology

JF - Journal of Thoracic Oncology

IS - 6

ER -

Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial

Abstract

Keywords

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