- Poster presentation
- Open Access
Phase III, randomized, open-label study of durvalumab (MEDI4736) in combination with tremelimumab or durvalumab alone versus platinum-based chemotherapy in first-line treatment of patients with advanced/metastatic NSCLC: MYSTIC
https://doi.org/10.1186/2051-1426-3-S2-P171
© Rizvi et al. 2015
- Published: 4 November 2015
Keywords
- Epidermal Growth Factor Receptor
- Anaplastic Lymphoma Kinase
- Immune Checkpoint
- Clinical Development Program
- Durable Benefit
Background
Platinum-based doublets are standard of care (SoC) first-line treatment for advanced NSCLC, but durable benefit is observed infrequently, with resistance to chemotherapy invariably developing. The blockade of immune checkpoints is a promising novel approach in cancer treatment. Blocking co-inhibitory molecules, such as programmed cell death-1 (PD-1) and cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), from binding with their ligands can restore T-cell responses against tumors. As these pathways are non-redundant, dual targeting may have additive or synergistic antitumor activity. Durvalumab (MEDI4736) is a selective, high affinity human IgG1 mAb that blocks programmed cell death ligand-1 (PD-L1) binding to PD-1 (IC50 0.1 nM) and CD80 (IC50 0.04 nM), and tremelimumab is a selective human IgG2 mAb inhibitor of CTLA-4. Durvalumab monotherapy has shown durable responses in a NSCLC cohort from a Phase I/II study in heavily pre-treated patients with solid tumors[1] and durvalumab plus tremelimumab has shown encouraging clinical activity and a manageable safety profile in a Phase Ib study in patients with NSCLC[2]. A comprehensive clinical development program of durvalumab +/- tremelimumab in NSCLC is underway. MYSTIC (NCT02453282) is a global Phase III study to determine the efficacy and safety of durvalumab plus tremelimumab combination therapy or durvalumab monotherapy versus SoC platinum-based doublets in the first-line treatment of patients with advanced or metastatic NSCLC.
Methods
Trial registration
ClinicalTrials.gov identifier NCT02453282.
Authors’ Affiliations
References
- Rizvi , et al: ASCO. 2015, Abstract 8032Google Scholar
- Antonia , et al: ASCO. 2015, Abstract 3014Google Scholar
Copyright
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.