Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study
Open accessAbstract
Background Limited evidence exists to show that adding a third agent to platinum-doublet chemotherapy improves efficacy in the first-line advanced non-small-cell lung cancer (NSCLC) setting. The anti-PD-1 antibody pembrolizumab has shown efficacy as monotherapy in patients with advanced NSCLC and has a non-overlapping toxicity profile with chemotherapy. We assessed whether the addition of pembrolizumab to platinum-doublet chemotherapy improves efficacy in patients with advanced non-squamous NSCLC.Methods In this randomised, open-label, phase 2 cohort of a multicohort study (KEYNOTE-021), patients were enrolled at 26 medical centres in the USA and Taiwan. Patients with chemotherapy-naive, stage IIIB or IV, non-squamous NSCLC without targetable EGFR or ALK genetic aberrations were randomly assigned (1:1) in blocks of four stratified by PD-L1 tumour proportion score (<1% vs ≥1%) using an interactive voice-response system to 4 cycles of pembrolizumab 200 mg plus carboplatin area under curve 5 mg/mL per min and pemetrexed 500 mg/m 2 every 3 weeks followed by pembrolizumab for 24 months and indefinite pemetrexed maintenance therapy or to 4 cycles of carboplatin and pemetrexed alone followed by indefinite pemetrexed maintenance therapy. The primary endpoint was the proportion of patients who achieved an objective response, defined as the percentage of patients with radiologically confirmed complete or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1 assessed by masked, independent central review, in the intention-to-treat population, defined as all patients who were allocated to study treatment. Significance threshold was p<0·025 (one sided). Safety was assessed in the as-treated population, defined as all patients who received at least one dose of the assigned study treatment. This trial, which is closed for enrolment but continuing for follow-up, is registered with ClinicalTrials.gov, number NCT02039674.Findings Between Nov 25, 2014, and Jan 25, 2016, 123 patients were enrolled; 60 were randomly assigned to the pembrolizumab plus chemotherapy group and 63 to the chemotherapy alone group. 33 (55%; 95% CI 42-68) of 60 patients in the pembrolizumab plus chemotherapy group achieved an objective response compared with 18 (29%; 18-41) of 63 patients in the chemotherapy alone group (estimated treatment difference 26% [95% CI 9-42%]; p=0·0016). The incidence of grade 3 or worse treatment-related adverse events was similar between groups (23 [39%] of 59 patients in the pembrolizumab plus chemotherapy group and 16 [26%] of 62 in the chemotherapy alone group). The most common grade 3 or worse treatment-related adverse events in the pembrolizumab plus chemotherapy group were anaemia (seven [12%] of 59) and decreased neutrophil count (three [5%]); an additional six events each occurred in two (3%) for acute kidney injury, decreased lymphocyte count, fatigue, neutropenia, and sepsis, and thrombocytopenia. In the chemotherapy alone group, the most common grade 3 or worse events were anaemia (nine [15%] of 62) and decreased neutrophil count, pancytopenia, and thrombocytopenia (two [3%] each). One (2%) of 59 patients in the pembrolizumab plus chemotherapy group experienced treatment-related death because of sepsis compared with two (3%) of 62 patients in the chemotherapy group: one because of sepsis and one because of pancytopenia.Interpretation Combination of pembrolizumab, carboplatin, and pemetrexed could be an effective and tolerable first-line treatment option for patients with advanced non-squamous NSCLC. This finding is being further explored in an ongoing international, randomised, double-blind, phase 3 study.Funding Merck & Co.
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Based on KEYNOTE-021, pembrolizumab plus chemotherapy has been approved by the FDA as the first-line treatment for advanced non-squamous NSCLC, regardless of PD-L1 level.
“Based on the results of KEYNOTE-021, pembrolizumab plus chemotherapy has been approved by the FDA as the first-line treatment for advanced non-squamous NSCLC, regardless of PD-L1 level [52].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [52]
In KEYNOTE-021 (phase 2), non-squamous NSCLC patients receiving pembrolizumab combined with standard chemotherapy (carboplatin and pemetrexed) had a higher response rate and longer PFS than did patients receiving standard chemotherapy.
“In the clinical trial KEYNOTE-021 (phase 2), non-squamous non-small cell lung cancer (NSCLC) patients receiving pembrolizumab combined with standard chemotherapy (carboplatin and pemetrexed) had a higher response rate and longer progression-free survival (PFS) than did patients receiving standard chemotherapy [52].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [52]
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- Authors
- Langer, C. J., Gadgeel, S. M., Borghaei, H., Papadimitrakopoulou, V. A., Patnaik, A., Powell, S. F., Gentzler, R. D., Martins, R. G., Stevenson, J. P., Jalal, S. I., Panwalkar, A., Yang, J. C.-H., Gubens, M., Sequist, L. V., Awad, M. M., Fiore, J., Ge, Y., Raftopoulos, H., & Gandhi, L.
- Affiliations
- Abramson Cancer Center (US)
- Wayne State University (US)
- Fox Chase Cancer Center (US)
- The University of Texas MD Anderson Cancer Center (US)
- South Texas Accelerated Research Therapeutics (US)
- Sanford Health (US)
- University of Virginia (US)
- Seattle Cancer Care Alliance (US)
- Cleveland Clinic (US)
- Indiana University School of Medicine (US)
- Sanford Medical Center (US)
- National Taiwan University Hospital (TW)
- University of California, San Francisco (US)
- Harvard University (US)
- Dana-Farber Cancer Institute (US)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- NYU Langone Health (US)
- Corresponding author
- Langer, Corey J
- ORCID
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2016-11
- Volume
- 17
- Issue
- 11
- Pages
- 1497-1508
- ISSN
- 1470-2045 (ISSN-L)
- PMC
- PMC6886237
- OpenAlex
- W2529904548
- Cited by
- 1,404
- References
- 29
- Citations by year
- 2026: 25 · 2025: 69 · 2024: 76 · 2023: 86 · 2022: 118 · 2021: 173 · 2020: 180 · 2019: 198 · 2018: 292 · 2017: 172 · 2016: 12 · 2015: 1
- FWCI
- 200.99
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Lancet Oncology (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Cancer Institute (P30CA022453)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Keywords
- pembrolizumab, carboplatin, pemetrexed, non-squamous non-small cell lung cancer, first-line therapy, anti-PD-1, immune checkpoint inhibitors, platinum-based chemotherapy, objective response rate, treatment-related adverse events, combination therapy
- MeSH terms
- Pemetrexed, Aged, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Carboplatin, Antibodies, Monoclonal, Humanized
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