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Clinical Trial
. 2018 Nov 22;379(21):2040-2051.
doi: 10.1056/NEJMoa1810865. Epub 2018 Sep 25.

Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer

Luis Paz-Ares  1 , Alexander Luft  1 , David Vicente  1 , Ali Tafreshi  1 , Mahmut Gümüş  1 , Julien Mazières  1 , Barbara Hermes  1 , Filiz Çay Şenler  1 , Tibor Csőszi  1 , Andrea Fülöp  1 , Jerónimo Rodríguez-Cid  1 , Jonathan Wilson  1 , Shunichi Sugawara  1 , Terufumi Kato  1 , Ki Hyeong Lee  1 , Ying Cheng  1 , Silvia Novello  1 , Balazs Halmos  1 , Xiaodong Li  1 , Gregory M Lubiniecki  1 , Bilal Piperdi  1 , Dariusz M Kowalski  1 ; KEYNOTE-407 Investigators
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Free article
Clinical Trial

Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer

Luis Paz-Ares et al. N Engl J Med. .
Free article

Abstract

Background: Standard first-line therapy for metastatic, squamous non-small-cell lung cancer (NSCLC) is platinum-based chemotherapy or pembrolizumab (for patients with programmed death ligand 1 [PD-L1] expression on ≥50% of tumor cells). More recently, pembrolizumab plus chemotherapy was shown to significantly prolong overall survival among patients with nonsquamous NSCLC VSports手机版. .

Methods: In this double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, 559 patients with untreated metastatic, squamous NSCLC to receive 200 mg of pembrolizumab or saline placebo for up to 35 cycles; all the patients also received carboplatin and either paclitaxel or nanoparticle albumin-bound [nab]-paclitaxel for the first 4 cycles V体育安卓版. Primary end points were overall survival and progression-free survival. .

Results: After a median follow-up of 7. 8 months, the median overall survival was 15. 9 months (95% confidence interval [CI], 13. 2 to not reached) in the pembrolizumab-combination group and 11. 3 months (95% CI, 9. 5 to 14. 8) in the placebo-combination group (hazard ratio for death, 0. 64; 95% CI, 0. 49 to 0. 85; P<0. 001). The overall survival benefit was consistent regardless of the level of PD-L1 expression. The median progression-free survival was 6. 4 months (95% CI, 6. 2 to 8. 3) in the pembrolizumab-combination group and 4. 8 months (95% CI, 4. 3 to 5. 7) in the placebo-combination group (hazard ratio for disease progression or death, 0. 56; 95% CI, 0. 45 to 0. 70; P<0. 001) V体育ios版. Adverse events of grade 3 or higher occurred in 69. 8% of the patients in the pembrolizumab-combination group and in 68. 2% of the patients in the placebo-combination group. Discontinuation of treatment because of adverse events was more frequent in the pembrolizumab-combination group than in the placebo-combination group (13. 3% vs. 6. 4%). .

Conclusions: In patients with previously untreated metastatic, squamous NSCLC, the addition of pembrolizumab to chemotherapy with carboplatin plus paclitaxel or nab-paclitaxel resulted in significantly longer overall survival and progression-free survival than chemotherapy alone VSports最新版本. (Funded by Merck Sharp & Dohme; KEYNOTE-407 ClinicalTrials. gov number, NCT02775435 . ). .

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