FDA Approval summary: Pembrolizumab, atezolizumab, and cemiplimab-rwlc as single agents for first-line treatment of Advanced/Metastatic PD-L1–high NSCLC

O Akinboro, E Larkins, LH Pai-Scherf, LN Mathieu… - Clinical Cancer …, 2022 - AACR
FDA's approval of cemiplimab-rwlc on February 22, 2021, follows prior approvals of
pembrolizumab and atezolizumab for similar indications as first-line treatment for patients …

Efficacy and safety of pembrolizumab as first-line therapy in advanced non-small cell lung cancer with at least 50% PD-L1 positivity: a multicenter retrospective cohort …

M Tamiya, A Tamiya, K Hosoya, Y Taniguchi… - Investigational new …, 2019 - Springer
Objectives As first line therapy, pembrolizumab provides longer progression free survival
(PFS) and overall survival (OS) than platinum doublets in programmed death ligand 1 (PD …

Pembrolizumab plus chemotherapy versus chemotherapy alone in patients with advanced non–small cell lung cancer without tumor PD‐L1 expression: A pooled …

H Borghaei, CJ Langer, L Paz‐Ares… - Cancer, 2020 - Wiley Online Library
Background Pembrolizumab plus platinum‐based chemotherapy has demonstrated
improved clinical outcomes over chemotherapy alone in patients with previously untreated …

[HTML][HTML] First-line ICI monotherapies for advanced non-small-cell lung cancer patients with PD-L1 of at least 50%: A cost-effectiveness analysis

Q Liu, Z Zhou, X Luo, L Yi, L Peng, X Wan… - Frontiers in …, 2021 - frontiersin.org
Objective: Three immune checkpoint inhibitors (ICIs), pembrolizumab, atezolizumab and
cemiplimab, have been successively approved as first-line treatments for advanced non …

Randomized clinical trial of pembrolizumab vs chemotherapy for previously untreated Chinese patients with PD‐L1‐positive locally advanced or metastatic non–small …

YL Wu, L Zhang, Y Fan, JY Zhou… - … Journal of Cancer, 2021 - Wiley Online Library
In the global KEYNOTE‐042 study (Clinicaltrials. gov, NCT02220894), pembrolizumab
significantly improved overall survival (OS) vs chemotherapy in patients with previously …

Updated analysis of KEYNOTE-024: pembrolizumab versus platinum-based chemotherapy for advanced non–small-cell lung cancer with PD-L1 tumor proportion …

M Reck, D Rodríguez–Abreu, AG Robinson… - Journal of Clinical …, 2019 - ascopubs.org
Purpose In the randomized, open-label, phase III KEYNOTE-024 study, pembrolizumab
significantly improved progression-free survival and overall survival (OS) compared with …

[HTML][HTML] Long-term real-world outcomes of first-line pembrolizumab monotherapy for metastatic non-small cell lung cancer with≥ 50% expression of programmed cell …

V Velcheti, X Hu, L Yang, MC Pietanza… - Frontiers in …, 2022 - frontiersin.org
Objectives Immune checkpoint inhibitors (ICIs) of programmed cell death 1/programmed cell
death ligand 1 (PD-1/PD-L1) have been rapidly adopted in US clinical practice for first-line …

KEYNOTE‐033: randomized phase 3 study of pembrolizumab vs docetaxel in previously treated, PD‐L1‐positive, advanced NSCLC

S Ren, J Feng, S Ma, HJ Chen, Z Ma… - … Journal of Cancer, 2023 - Wiley Online Library
Abstract KEYNOTE‐033 (NCT02864394) was a multicountry, open‐label, phase 3 study that
compared pembrolizumab vs docetaxel in previously treated, programmed death‐ligand 1 …

Five-year outcomes with pembrolizumab versus chemotherapy as first-line therapy in patients with non–small-cell lung cancer and programmed death ligand-1 tumor …

G de Castro Jr, I Kudaba, YL Wu, G Lopes… - Journal of clinical …, 2023 - ascopubs.org
Clinical trials frequently include multiple end points that mature at different times. The initial
report, typically based on the primary end point, may be published when key planned co …

FDA approval summary: pembrolizumab for the treatment of patients with metastatic non-small cell lung cancer whose tumors express programmed death-ligand 1

J Sul, GM Blumenthal, X Jiang, K He, P Keegan… - The …, 2016 - academic.oup.com
Abstract On October 2, 2015, the US Food and Drug Administration (FDA) granted
accelerated approval for pembrolizumab, a breakthrough therapy-designated drug, for the …