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Nivolumab in Combination With Platinum‐Based Doublet Chemotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer
Open accessAbstract
Purpose: Nivolumab, a fully human immunoglobulin G4 programmed death-1 immune checkpoint inhibitor antibody, has demonstrated improved survival in previously treated patients with advanced non–small-cell lung cancer (NSCLC). CheckMate 012, a phase I, multicohort study, was conducted to explore the safety and efficacy of nivolumab as monotherapy or combined with current standard therapies in first-line advanced NSCLC. Here, we report results for nivolumab plus platinum-based doublet chemotherapy (PT-DC). Patients and Methods: Patients (N = 56) received nivolumab (intravenously) plus PT-DC concurrently every 3 weeks for four cycles followed by nivolumab alone until progression or unacceptable toxicity. Regimens were nivolumab 10 mg/kg plus gemcitabine-cisplatin (squamous) or pemetrexed-cisplatin (nonsquamous) or nivolumab 5 or 10 mg/kg plus paclitaxel-carboplatin (all histologies). The primary objective was to assess safety and tolerability. Secondary objectives included objective response rate and 24-week progression-free survival rate (per Response Evaluation Criteria in Solid Tumors version 1.1); exploratory objectives included overall survival (OS) and response by tumor programmed death ligand-1 expression. Results: No dose-limiting toxicities occurred during the first 6 weeks of treatment. Forty-five percent of patients (25 of 56 patients) reported grade 3 or 4 treatment-related adverse events (AEs); 7% of patients (n = 4) had pneumonitis. Twenty-one percent of patients (n = 12) discontinued all study therapy as a result of treatment-related AEs. Objective response rates for nivolumab 10 mg/kg plus gemcitabine-cisplatin, nivolumab 10 mg/kg plus pemetrexed-cisplatin, nivolumab 10 mg/kg plus paclitaxel-carboplatin, and nivolumab 5 mg/kg plus paclitaxel-carboplatin were 33%, 47%, 47%, and 43%, respectively; 24-week progression-free survival rates were 51%, 71%, 38%, and 51%, respectively; 2-year OS rates were 25%, 33%, 27%, and 62%, respectively. Responses were achieved regardless of tumor programmed death ligand-1 expression. Conclusion: The safety profile of nivolumab plus PT-DC was consistent with that expected for individual agents; however, treatment discontinuation related to AEs was greater with the combination. Encouraging activity was observed, especially for the nivolumab 5 mg/kg plus paclitaxel-carboplatin group, with a 2-year OS rate of 62%.
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Cites
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Self-citationNivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer
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Self-citationNivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer
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Self-citationPembrolizumab for the Treatment of Non–Small-Cell Lung Cancer
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Self-citationPaclitaxel–Carboplatin Alone or with Bevacizumab for Non–Small-Cell Lung Cancer
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Metadata
- Authors
- Rizvi, N. A., Hellmann, M. D., Brahmer, J. R., Juergens, R. A., Borghaei, H., Gettinger, S., Chow, L. Q., Gerber, D. E., Laurie, S. A., Goldman, J. W., Shepherd, F. A., Chen, A. C., Shen, Y., Nathan, F. E., Harbison, C. T., & Antonia, S.
- Venue
- Journal of Clinical Oncology
- Published
- 2016-09-01
- Volume
- 34
- Issue
- 25
- Pages
- 2969-2979
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2464620827
- Cited by
- 445
- References
- 36
- FWCI
- 36.00
- Type
- journal article
- Language
- en
- Open access
- green
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- Rizvi, N. A., Hellmann, M. D., Brahmer, J. R., Juergens, R. A., Borghaei, H., Gettinger, S., Chow, L. Q., Gerber, D. E., Laurie, S. A., Goldman, J. W., Shepherd, F. A., Chen, A. C., Shen, Y., Nathan, F. E., Harbison, C. T., & Antonia, S. (2016). Nivolumab in Combination With Platinum‐Based Doublet Chemotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2016.66.9861
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