Pembrolizumab plus chemotherapy in metastatic non–small-cell lung cancer
Open accessAbstract
BACKGROUND: First-line therapy for advanced non-small-cell lung cancer (NSCLC) that lacks targetable mutations is platinum-based chemotherapy. Among patients with a tumor proportion score for programmed death ligand 1 (PD-L1) of 50% or greater, pembrolizumab has replaced cytotoxic chemotherapy as the first-line treatment of choice. The addition of pembrolizumab to chemotherapy resulted in significantly higher rates of response and longer progression-free survival than chemotherapy alone in a phase 2 trial. METHODS: In this double-blind, phase 3 trial, we randomly assigned (in a 2:1 ratio) 616 patients with metastatic nonsquamous NSCLC without sensitizing EGFR or ALK mutations who had received no previous treatment for metastatic disease to receive pemetrexed and a platinum-based drug plus either 200 mg of pembrolizumab or placebo every 3 weeks for 4 cycles, followed by pembrolizumab or placebo for up to a total of 35 cycles plus pemetrexed maintenance therapy. Crossover to pembrolizumab monotherapy was permitted among the patients in the placebo-combination group who had verified disease progression. The primary end points were overall survival and progression-free survival, as assessed by blinded, independent central radiologic review. RESULTS: After a median follow-up of 10.5 months, the estimated rate of overall survival at 12 months was 69.2% (95% confidence interval [CI], 64.1 to 73.8) in the pembrolizumab-combination group versus 49.4% (95% CI, 42.1 to 56.2) in the placebo-combination group (hazard ratio for death, 0.49; 95% CI, 0.38 to 0.64; P<0.001). Improvement in overall survival was seen across all PD-L1 categories that were evaluated. Median progression-free survival was 8.8 months (95% CI, 7.6 to 9.2) in the pembrolizumab-combination group and 4.9 months (95% CI, 4.7 to 5.5) in the placebo-combination group (hazard ratio for disease progression or death, 0.52; 95% CI, 0.43 to 0.64; P<0.001). Adverse events of grade 3 or higher occurred in 67.2% of the patients in the pembrolizumab-combination group and in 65.8% of those in the placebo-combination group. CONCLUSIONS: In patients with previously untreated metastatic nonsquamous NSCLC without EGFR or ALK mutations, the addition of pembrolizumab to standard chemotherapy of pemetrexed and a platinum-based drug resulted in significantly longer overall survival and progression-free survival than chemotherapy alone. (Funded by Merck; KEYNOTE-189 ClinicalTrials.gov number, NCT02578680 .).
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Many of the studies used ICIs as monotherapy in a heavily pretreated population, whereas current standard first-line therapy often includes combination ICIs or ICI with chemotherapy for multiple tumor types.
“Third, many of these studies utilized ICIs as monotherapy in a heavily pretreated population whereas current standard first-line therapy often includes a combination of ICIs or ICI with chemotherapy for multiple tumor types (35–40).”
From A Uniform Computational Approach Improved on Existing Pipelines to Reveal Microbiome Biomarkers of Nonresponse to Immune Checkpoint Inhibitors (2021) · cites this paper as [37]
KRAS mutation-positive patients derived benefit in both PFS and OS from pembrolizumab plus chemotherapy versus platinum doublet therapy alone as first-line therapy for metastatic NSCLC.
“KRAS mutation-positive patients derived benefit in both PFS and OS from the combination of pembrolizumab plus chemotherapy as opposed to platinum doublet therapy alone as first-line therapy for patients with metastatic NSCLC66.”
From Selective KRAS G12C inhibitors in non-small cell lung cancer: chemistry, concurrent pathway alterations, and clinical outcomes (2021) · cites this paper as [66]
Addition of pembrolizumab significantly prolongs survival of NSCLC patients.
“Importantly, two remarkable phase III trials (KEYNOTE-189 and KEYNOTE-407) demonstrated that addition of pembrolizumab (Keytruda, anti-PD1) could significantly prolong the survival of NSCLC patients (45, 97).”
From New Horizons in KRAS-Mutant Lung Cancer: Dawn After Darkness (2019) · cites this paper as [97]
Pembrolizumab in combination with chemotherapy is approved for metastatic, non-squamous NSCLC and for squamous lung carcinoma excluding EGFR or ALK mutations.
“The promising results from these studies have led to the approval of pembrolizumab in combination with chemotherapy (carboplatin-pemetrexed) for metastatic, non-squamous NSCLC, and the approval of pembrolizumab in combination with chemotherapy (carboplatin and Taxol) for patients with squamous lung carcinoma, excluding those carrying EGFR or ALK mutations.”
From New Horizons in KRAS-Mutant Lung Cancer: Dawn After Darkness (2019) · cites this paper as [97]
Phase III data show overall survival and/or progression-free survival benefit for immune checkpoint therapy plus chemotherapy in non-small cell lung cancer, small cell lung cancer, triple-negative breast cancer, bladder cancer, and head and neck squamous cell carcinoma.
“Toward this end, combinations of ICTs with concurrent and/or sequential chemotherapy are under extensive investigation, with phase III clinical data demonstrating overall survival and/or progression-free survival benefi t in NSCLC ( 63-66 ), small cell lung cancer ( 51,52 ), triple-negative breast cancer ( 67 ), bladder cancer ( 53 ), and head and neck squamous cell carcinoma ( 68 ).”
From The Next Decade of Immune Checkpoint Therapy (2021) · cites this paper as [63]
In KEYNOTE-189 and KEYNOTE-407 (phase 3), pembrolizumab combined with standard chemotherapy led to better OS and PFS in NSCLC patients, relative to chemotherapy monotherapy.
“Later, in two phase 3 clinical studies (KEYNOTE-189 and KEYNOTE-407), pembrolizumab combined with standard chemotherapy led to a better overall survival (OS) and PFS in NSCLC patients, relative to chemotherapy monotherapy [53, 54].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [53]
ORR, median PFS, and median DOR reported for the two treatment arms were consistent with those reported in the KEYNOTE-189 and KEYNOTE-407 trials of pembrolizumab i.v. plus chemotherapy for the treatment of mNSCLC.
“Moreover, ORR, median PFS, and median DOR reported for the two treatment arms were consistent with those reported in the KEYNOTE-189 and KEYNOTE-407 trials of pembrolizumab i.v.þ chemotherapy for the treatment of mNSCLC.22,23”
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BackgroundSelf-citationFerroptosis, necroptosis, and pyroptosis in anticancer immunity
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Self-citationThe lung microenvironment: an important regulator of tumour growth and metastasis
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“METHODS Patients and Study Design The study design has been previously described.(6) Briefly, patients had previously untreated pathologically confirmed metastatic nonsquamous NSCLC without sensitizing EGFR/ ALK alterations, Eastern Cooperative Oncology Group performance status of 0/1, and$ 1 measurable lesion, and pr…”
BackgroundMethodInfluentialSelf-citationToward personalized treatment approaches for non-small-cell lung cancer
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Clinical implications of T cell exhaustion for cancer immunotherapy
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NCCN Guidelines Insights: Non–Small Cell Lung Cancer, Version 1.2020
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“These findings are consistent with those of pembrolizumab plus chemotherapy in NSCLC.16,17 0 3 6 9 12 15 18 21 24 27 30 33 10 20 30 40 50 60 70 80 90 100 Time (months) On go in g Re po ns e (% ) 19.3% 3.3% 16.3% 1.3% 161 107 49 32 8 3 0 0 139 82 17 8 1 1 0 0 25 4 18 3 1 1 0 0 Pembrolizumab plus EP Placebo plus EP No.…”
ResultInfluentialSelf-citationPembrolizumab plus Chemotherapy in Advanced Endometrial Cancer
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Self-citationThe PD-1/PD-L1-Checkpoint Restrains T cell Immunity in Tumor-Draining Lymph Nodes
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“Even in large phase III studies of ICIs combined with chemotherapy, overall response rates are 47%–63% at best (24, 25, 28).”
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“Pembrolizumab + pemetrexed /platinum First‐line non‐squamous NSCLC May 10, 2017 [50, 296]”
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Self-citationRare epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer
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“While standard of care for patients with aggressive cancer showing rapid expansion is platinum-doublet chemotherapy, these results provides the biological rationale for previous work demonstrating why combination therapy is a viable option in first-line metastatic settings [43].”
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“Currently, three combinations have been approved for first-line treatment, all for advanced NSCLC [120, 147, 148].”
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Self-citationApplication of PD-1 Blockade in Cancer Immunotherapy
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“In August 2018, FDA has approved an expanded label for pembrolizumab in combinationwith pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations, based on results of the KEYNOTE-189 trial [61].”
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Targeting the gut and tumor microbiota in cancer
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Intratumoural administration and tumour tissue targeting of cancer immunotherapies
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- Authors
- Gandhi, L., Rodríguez-Abreu, D., Gadgeel, S., Esteban, E., Felip, E., De Angelis, F., Domine, M., Clingan, P., Hochmair, M. J., Powell, S. F., Cheng, S. Y.-S., Bischoff, H. G., Peled, N., Grossi, F., Jennens, R. R., Reck, M., Hui, R., Garon, E. B., Boyer, M., Rubio-Viqueira, B., Novello, S., Kurata, T., Gray, J. E., Vida, J., Wei, Z., Yang, J., Raftopoulos, H., Pietanza, M. C., & Garassino, M. C.
- Affiliations
- Universidad de Las Palmas de Gran Canaria (ES)
- From NYU Perlmutter Cancer Center, New York (L.G.); Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria (D.R.-A.), Hospital Universitario Central de Asturias, Oviedo (E.E.), Vall d’Hebron University, Vall d’Hebron Institute of Oncology, Barcelona (E.F.), and Fundación Jiménez Díaz (M.D.) and Hospital Universitario Quirón Madrid (B.R.-V.), Madrid — all in Spain; Karmanos Cancer Institute, Detroit (S.G.);...
- ORCID
- Gandhi, Leena
- Gadgeel, Shirish
- Esteban, Emilio
- Felip, Enriqueta
- Clingan, Philip
- Hochmair, Maximilian J.
- Powell, Steven F.
- Bischoff, Helge G.
- Peled, Nir
- Grossi, Francesco
- Jennens, Ross R.
- Reck, Martin
- Hui, Rina
- Garon, Edward B.
- Boyer, Michael
- Novello, Silvia
- Kurata, Takayasu
- Gray, Jhanelle E.
- Wei, Ziwen
- Yang, Jing
- Pietanza, M. Catherine
- Garassino, Marina C.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2018-05-31
- Volume
- 378
- Issue
- 22
- Pages
- 2078-2092
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2796582438
- Cited by
- 6,607
- References
- 31
- Citations by year
- 2026: 484 · 2025: 646 · 2024: 777 · 2023: 824 · 2022: 901 · 2021: 1039 · 2020: 964 · 2019: 677 · 2018: 284 · 2017: 2 · 2013: 1
- FWCI
- 559.94
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion, other-oa)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
- Radboud Repository (Radboud University) (submittedVersion)
- Acceda (Universidad de Las Palmas de Gran Canaria) (submittedVersion)
- Digital Access to Libraries (submittedVersion, other-oa)
- Työväentutkimus Vuosikirja (submittedVersion, other-oa)
- IrInSubria (University of Insubria) (submittedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion, other-oa)
- Funders
- Merck
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- pembrolizumab, metastatic non-small cell lung cancer, PD-L1, pemetrexed, platinum-based chemotherapy, immune checkpoint inhibitors, first-line therapy, overall survival, progression-free survival, PD-L1 expression, maintenance therapy, treatment safety, immune-related adverse events, pneumonitis, diarrhea, rash, hyperphosphatemia
- MeSH terms
- Antineoplastic Agents, Immunological, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Double-Blind Method, Female, Follow-Up Studies, Humans, Lung Neoplasms, Male, Middle Aged, Disease-Free Survival, Kaplan-Meier Estimate, Antibodies, Monoclonal, Humanized
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