RT Journal Article
T1 A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407.
A1 Paz-Ares, Luis
A1 Vicente, David
A1 Tafreshi, Ali
A1 Robinson, Andrew
A1 Soto Parra, Hector
A1 Mazières, Julien
A1 Hermes, Barbara
A1 Cicin, Irfan
A1 Medgyasszay, Balazs
A1 Rodríguez-Cid, Jerónimo
A1 Okamoto, Isamu
A1 Lee, SungSook
A1 Ramlau, Rodryg
A1 Vladimirov, Vladimir
A1 Cheng, Ying
A1 Deng, Xuan
A1 Zhang, Ying
A1 Bas, Tuba
A1 Piperdi, Bilal
A1 Halmos, Balazs
K1 Chemotherapy
K1 PD-L1
K1 Pembrolizumab
K1 Squamous non–small-cell lung cancer
AB In the randomized KEYNOTE-407 study (ClinicalTrials.gov, NCT02775435), pembrolizumab plus carboplatin and paclitaxel/nab-paclitaxel (chemotherapy) significantly improved overall survival (OS) and progression-free survival (PFS) compared with placebo plus chemotherapy in patients with previously untreated metastatic squamous NSCLC. We report updated efficacy outcomes from the protocol-specified final analysis and, for the first time, progression on next line of treatment. Eligible patients were randomized to chemotherapy plus either pembrolizumab (n = 278) or placebo (n = 281). After positive results from the second interim analysis, patients still receiving placebo could cross over to pembrolizumab monotherapy at the time of confirmed progressive disease. The primary end points were OS and PFS. PFS-2 (time from randomization to progression on next-line treatment/death, whichever occurred first) was an exploratory end point. After median (range) follow-up of 14.3 (0.1-31.3) months, pembrolizumab plus chemotherapy continued to exhibit a clinically meaningful improvement over placebo plus chemotherapy in OS (median, 17.1 mo [95% confidence interval (CI): 14.4‒19.9] versus 11.6 mo [95% CI: 10.1‒13.7]; hazard ratio [HR], 0.71 [95% CI: 0.58‒0.88]) and PFS (median, 8.0 mo [95% CI: 6.3‒8.4] versus 5.1 mo [95% CI: 4.3‒6.0]; HR, 0.57 [95% CI: 0.47‒0.69]). PFS-2 was longer for patients randomized to first-line pembrolizumab plus chemotherapy (HR, 0.59 [95% CI: 0.49‒0.72]). Grade 3 to 5 adverse events occurred in 74.1% and 69.6% of patients receiving pembrolizumab plus chemotherapy and placebo plus chemotherapy, respectively. Pembrolizumab plus chemotherapy continued to exhibit substantially improved OS and PFS in patients with metastatic squamous NSCLC. The PFS-2 outcomes support pembrolizumab plus chemotherapy as a standard first-line treatment in patients with metastatic squamous NSCLC.
YR 2020
FD 2020-06-26
LK http://hdl.handle.net/10668/15844
UL http://hdl.handle.net/10668/15844
LA en
DS RISalud
RD Apr 6, 2025