Journal article
Outcomes With Pembrolizumab Monotherapy in Patients With Programmed Death-Ligand 1–Positive NSCLC With Brain Metastases: Pooled Analysis of KEYNOTE-001, 010, 024, and 042
JTO clinical and research reports, v 2(8), 100205
01 Aug 2021
PMID: 34590048
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
We retrospectively evaluated outcomes in patients with programmed death-ligand 1 (PD-L1)–positive NSCLC to determine whether baseline (i.e., at study enrollment) brain metastases were associated with the efficacy of pembrolizumab versus chemotherapy.
We pooled the data for patients with previously treated or untreated PD-L1‒positive (tumor proportion score [TPS], ≥1%) advanced metastatic NSCLC in KEYNOTE-001 (NCT01295827), KEYNOTE-010 (NCT01905657), KEYNOTE-024 (NCT02142738), and KEYNOTE-042 (NCT02220894). Patients received pembrolizumab (2 mg/kg, 10 mg/kg, or 200 mg every 3 wk or 10 mg/kg every 2 wk); chemotherapy was a comparator in all studies except KEYNOTE-001. All studies included patients with previously treated, stable brain metastases.
A total of 3170 patients were included, 293 (9.2%) with and 2877 (90.8%) without baseline brain metastases; median (range) follow-up at data cutoff was 12.9 (0.1‒43.7) months. Pembrolizumab improved overall survival versus chemotherapy in patients with or without baseline brain metastases: benefit was seen in patients with PD-L1 TPS greater than or equal to 50% (0.67 [95% confidence intervals (CI): 0.44‒1.02] and 0.66 [95% CI: 0.58‒0.76], respectively) and PD-L1 TPS ≥1% (0.83 [95% CI: 0.62‒1.10] and 0.78 [95% CI: 0.71‒0.85], respectively). Progression-free survival was improved, objective response rates were higher, and the duration of response was longer with pembrolizumab versus chemotherapy regardless of brain metastasis status. The incidence of treatment-related adverse events with pembrolizumab versus chemotherapy was 66.3% versus 84.4% in patients with brain metastases and 67.2% versus 88.3% in those without.
Pembrolizumab monotherapy improved outcomes and was associated with fewer adverse events than chemotherapy in patients with treatment-naive and previously treated PD-L1‒positive advanced/metastatic NSCLC regardless of the presence of baseline treated, stable brain metastases.
Metrics
Details
- Title
- Outcomes With Pembrolizumab Monotherapy in Patients With Programmed Death-Ligand 1–Positive NSCLC With Brain Metastases: Pooled Analysis of KEYNOTE-001, 010, 024, and 042
- Creators
- Aaron S. Mansfield - Mayo ClinicRoy S. Herbst - Yale Cancer CenterGilberto de Castro - Instituto do Câncer do Estado de São PauloRina Hui - Westmead HospitalNir Peled - Ben-Gurion University of the NegevDong-Wan Kim - Seoul National University HospitalSilvia Novello - Ospedale San Luigi GonzagaMiyako Satouchi - Hyogo Prefectural Cancer CenterYi-Long Wu - Guangdong Academy of Medical SciencesEdward B. Garon - University of California, Los AngelesMartin Reck - LungenClinic GrosshansdorfAndrew G. Robinson - Kingston General HospitalAyman Samkari - MSD (Mexico)Bilal Piperdi - Merck & Co., Inc., Rahway, NJ, USA (United States)Victoria Ebiana - MSD (Mexico)Jianxin Lin - Merck & Co., Inc., Rahway, NJ, USA (United States)Tony S.K. Mok - State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, People’s Republic of China
- Publication Details
- JTO clinical and research reports, v 2(8), 100205
- Publisher
- Elsevier
- Grant note
- Taiho Pharmaceutical (https://doi.org/10.13039/100009954) EMD Serono (https://doi.org/10.13039/100004755) Spectrum Pharmaceuticals (https://doi.org/10.13039/100006399) AstraZeneca (https://doi.org/10.13039/100004325) Celgene (https://doi.org/10.13039/100006436) Amgen (https://doi.org/10.13039/100002429) Shire Genentech/Roche Ignyta (https://doi.org/10.13039/100014584) AbbVie (https://doi.org/10.13039/100006483) FMI Eli Lilly Seattle Genetics (https://doi.org/10.13039/100010293) Boehringer Ingelheim (https://doi.org/10.13039/100008349) Sanofi (https://doi.org/10.13039/100004339) Chugai Pharmaceutical (https://doi.org/10.13039/100010795) Novartis (https://doi.org/10.13039/100004336) Merck Sharp & Dohme (https://doi.org/10.13039/100009947) Clovis Oncology (https://doi.org/10.13039/100014487) Pfizer (https://doi.org/10.13039/100004319) National Institutes of Health (https://doi.org/10.13039/100000002) Merck (https://doi.org/10.13039/100004334) Mesothelioma Applied Research Foundation (https://doi.org/10.13039/100001755) Bayer (https://doi.org/10.13039/100004326) Roche (https://doi.org/10.13039/100004337) Ono Pharmaceutical (https://doi.org/10.13039/501100013170) ACEA Biosciences, Inc. (https://doi.org/10.13039/100013767) Merck Serono Takeda Oncology (https://doi.org/10.13039/100011957) Vertex Pharmaceuticals (https://doi.org/10.13039/100011022) Bristol-Myers Squibb (https://doi.org/10.13039/100002491)
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pediatrics
- Web of Science ID
- WOS:001137466100004
- Scopus ID
- 2-s2.0-85112615261
- Other Identifier
- 991021838288804721
UN Sustainable Development Goals (SDGs)
This publication has contributed to the advancement of the following goals:
InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Oncology
- Respiratory System