Sriuranpong, V. and Altundag, O. and Clingan, P. and Rizvi, N. and Aren Frontera, O. and Sezer, A. and Paydas, S. and Shavdia, M. and Bondarenko, I. and Gladkov, O. and Lee, S. and Li, S. and Snodgrass, P. and Rietschel, P. (2018) EMPOWER-lung 1: A randomized, open-label, multi-national, phase III trial of cemiplimab, a human PD-1 monoclonal antibody, versus chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC) with PD-L1 50%. Annals of Oncology, Vol.29 (Sup.10). mdy487.039. ISSN 0923-7534 (Print), 1569-8041 (Electronic)
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Abstract
Background: Most patients (pts) with NSCLC present with advanced disease at diagnosis. Systemic therapy with platinum-based doublet chemotherapy regimens has been the standard first-line treatment for pts with advanced NSCLC whose tumours do not have EGFR, ALK, or ROS 1 mutations, but there is a need for effective treatments to improve long-term survival. With the recognition that NSCLC tumours express PD-L1, checkpoint inhibitors are being investigated in several clinical trials. There is currently only one PD-1 inhibitor approved as monotherapy in first-line treatment of NSCLC with PD-L1 expression ≥50%. In a phase 1 dose escalation and NSCLC expansion cohort, cemiplimab (REGN2810), a human monoclonal anti-PD-1, has demonstrated antitumour activity with an acceptable safety profile in anti-PD-1 naïve, pre-treated pts with NSCLC. Trial design: This is a randomised (1:1), multicentre, open-label, phase 3 study of cemiplimab versus platinum-based doublet chemotherapy in systemic treatment-naïve pts (≥18 years) with stage IIIB, IIIC or IV squamous or non-squamous NSCLC whose tumours express PD-L1 in ≥ 50% of tumour cells (NCT03088540).
| Item Type: | Article |
|---|---|
| Additional Information: | Annals of Oncology, Volume 29, Issue suppl_10, December 2018, mdy487.039, https://doi.org/10.1093/annonc/mdy487.039 Abstract Book of ESMO Immuno-Oncology Congress 2018 13–16 December, Geneva, Switzerland |
| Uncontrolled Keywords: | lung, chemotherapy regimen, monoclonal antibodies, non-small-cell lung carcinoma, phase 3 clinical trials, programmed cell death 1 ligand 1 |
| Subjects: | Oncology |
| Depositing User: | Елена Шрамко |
| Date Deposited: | 28 Mar 2019 14:56 |
| Last Modified: | 28 Mar 2019 14:56 |
| URI: | http://repo.dma.dp.ua/id/eprint/3968 |
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