Nature Medicine, volume 28, issue 11, pages 2374-2380
Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial
Miranda Gogishvili
1
,
Tamar Melkadze
2
,
Tamta Makharadze
3
,
Davit Giorgadze
4
,
Mikhail Dvorkin
5
,
Konstantin Penkov
6
,
Konstantin Laktionov
7
,
Gia Nemsadze
8
,
Marina Nechaeva
9
,
Irina Rozhkova
10
,
Ewa Kalinka
11
,
Christian Gessner
12, 13
,
Brizio Moreno Jaime
14
,
Rodolfo Passalacqua
15
,
Siyu Li
16
,
Kristina McGuire
16
,
Manika Kaul
16
,
Anne Paccaly
16
,
Ruben G. W. Quek
16
,
Bo Gao
16
,
Frank Seebach
16
,
David M. Weinreich
16
,
George D. Yancopoulos
16
,
Israel Lowy
16
,
Giuseppe Gullo
16
,
Petra Rietschel
16
1
High Technology Medical Centre, University Clinic Ltd., Tbilisi, Georgia
|
2
Acad. F. Todua Medical Center, Tbilisi, Georgia
|
3
LTD High Technology Hospital Med Center, Batumi, Georgia
|
5
State Budgetary Healthcare Institution of Omsk Region, Omsk, Russia
|
6
Private Medical Institution Euromedservice, Saint Petersburg, Russia
|
8
The Institute of Clinical Oncology, Tbilisi, Georgia
|
9
Chelyabinsk Regional Clinical Oncology Center, Chelyabinsk, Chelyabinsk, Russia
|
10
Kaluga Regional Clinical Oncology Dispensary, Kaluga, Russia
|
11
Polish Mother’s Memorial Hospital Research Institute, Łódź, Poland
|
12
POIS Leipzig GbR, Leipzig, Germany
|
14
Hospital Regional ISSSTE, León, Mexico
|
15
Istituti Ospitalieri Di Cremona, Cremona, Italy
|
16
Regeneron Pharmaceuticals, Inc., Tarrytown, USA
|
Publication type: Journal Article
Publication date: 2022-08-25
Journal:
Nature Medicine
Quartile SCImago
Q1
Quartile WOS
Q1
Impact factor: 82.9
ISSN: 10788956, 1546170X, 17447933
General Biochemistry, Genetics and Molecular Biology
General Medicine
Abstract
First-line cemiplimab (anti-programmed cell death-1 (PD-1)) monotherapy has previously shown significant improvement in overall survival (OS) and progression-free survival (PFS) versus chemotherapy in patients with advanced non-small cell lung cancer (aNSCLC) and PD-ligand 1 (PD-L1) expression ≥50%. EMPOWER-Lung 3 ( NCT03409614 ), a double-blind, placebo-controlled, phase 3 study, examined cemiplimab plus platinum-doublet chemotherapy as first-line treatment for aNSCLC, irrespective of PD-L1 expression or histology. In this study, 466 patients with stage III/IV aNSCLC without EGFR, ALK or ROS1 genomic tumor aberrations were randomized (2:1) to receive cemiplimab 350 mg (n = 312) or placebo (n = 154) every 3 weeks for up to 108 weeks in combination with four cycles of platinum-doublet chemotherapy (followed by pemetrexed maintenance as indicated). In total, 57.1% (266/466 patients) had non-squamous NSCLC, and 85.2% (397/466 patients) had stage IV disease. The primary endpoint was OS. The trial was stopped early per recommendation of the independent data monitoring committee, based on meeting preset OS efficacy criteria: median OS was 21.9 months (95% confidence interval (CI), 15.5–not evaluable) with cemiplimab plus chemotherapy versus 13.0 months (95% CI, 11.9–16.1) with placebo plus chemotherapy (hazard ratio (HR) = 0.71; 95% CI, 0.53–0.93; P = 0.014). Grade ≥3 adverse events occurred with cemiplimab plus chemotherapy (43.6%, 136/312 patients) and placebo plus chemotherapy (31.4%, 48/153 patients). Cemiplimab is only the second anti-PD-1/PD-L1 agent to show efficacy in aNSCLC as both monotherapy and in combination with chemotherapy for both squamous and non-squamous histologies. Results from EMPOWER-Lung 3 demonstrate increased overall survival with cemiplimab plus platinum-doublet chemotherapy compared to cemiplimab as first-line treatment in patients with advanced non-small cell lung cancer, irrespective of PD-L1 expression.
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Gogishvili M. et al. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial // Nature Medicine. 2022. Vol. 28. No. 11. pp. 2374-2380.
GOST all authors (up to 50)
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Gogishvili M., Melkadze T., Makharadze T., Giorgadze D., Dvorkin M., Penkov K., Laktionov K., Nemsadze G., Nechaeva M., Rozhkova I., Kalinka E., Gessner C., Moreno Jaime B., Passalacqua R., Li S., McGuire K., Kaul M., Paccaly A., Quek R. G. W., Gao B., Seebach F., Weinreich D. M., Yancopoulos G. D., Lowy I., Gullo G., Rietschel P. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial // Nature Medicine. 2022. Vol. 28. No. 11. pp. 2374-2380.
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TY - JOUR
DO - 10.1038/s41591-022-01977-y
UR - https://doi.org/10.1038/s41591-022-01977-y
TI - Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial
T2 - Nature Medicine
AU - Gogishvili, Miranda
AU - Melkadze, Tamar
AU - Makharadze, Tamta
AU - Giorgadze, Davit
AU - Dvorkin, Mikhail
AU - Penkov, Konstantin
AU - Laktionov, Konstantin
AU - Nemsadze, Gia
AU - Nechaeva, Marina
AU - Rozhkova, Irina
AU - Kalinka, Ewa
AU - Gessner, Christian
AU - Moreno Jaime, Brizio
AU - Passalacqua, Rodolfo
AU - Li, Siyu
AU - McGuire, Kristina
AU - Kaul, Manika
AU - Paccaly, Anne
AU - Quek, Ruben G. W.
AU - Gao, Bo
AU - Seebach, Frank
AU - Weinreich, David M.
AU - Yancopoulos, George D.
AU - Lowy, Israel
AU - Gullo, Giuseppe
AU - Rietschel, Petra
PY - 2022
DA - 2022/08/25
PB - Springer Nature
SP - 2374-2380
IS - 11
VL - 28
SN - 1078-8956
SN - 1546-170X
SN - 1744-7933
ER -
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@article{2022_Gogishvili,
author = {Miranda Gogishvili and Tamar Melkadze and Tamta Makharadze and Davit Giorgadze and Mikhail Dvorkin and Konstantin Penkov and Konstantin Laktionov and Gia Nemsadze and Marina Nechaeva and Irina Rozhkova and Ewa Kalinka and Christian Gessner and Brizio Moreno Jaime and Rodolfo Passalacqua and Siyu Li and Kristina McGuire and Manika Kaul and Anne Paccaly and Ruben G. W. Quek and Bo Gao and Frank Seebach and David M. Weinreich and George D. Yancopoulos and Israel Lowy and Giuseppe Gullo and Petra Rietschel},
title = {Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial},
journal = {Nature Medicine},
year = {2022},
volume = {28},
publisher = {Springer Nature},
month = {aug},
url = {https://doi.org/10.1038/s41591-022-01977-y},
number = {11},
pages = {2374--2380},
doi = {10.1038/s41591-022-01977-y}
}
Cite this
MLA
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Gogishvili, Miranda, et al. “Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial.” Nature Medicine, vol. 28, no. 11, Aug. 2022, pp. 2374-2380. https://doi.org/10.1038/s41591-022-01977-y.