Spigel, D.R. and Bondarenko, I. and Losonczy, G. and Mezger, J. and Kalofonos, H. and Reck, M. and Palmero, R. and Jang, T. and Natale, R. and Sanborn, R.E. and Lai, J. and Kallinteris, N. and Tang, M. and Shan, J. and Gerber, D. (2016) Top-line results from SUNRISE: A phase III, randomized, double-blind, placebo-controlled multicenter trial of bavituximab plus docetaxel in patients with previously treated stage IIIb/iv non-squamous non-small cell lung cancer. Annals of Oncology, Vol.27 (supp_6). P.- LBA45. ISSN 0923-7534 (Print), 1569-8041 (Electronic)
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Abstract
Background: Exposed phosphatidylserine (PS) in the tumor microenvironment is highly immunosuppressive. Bavituximab targets PS in the presence of β2GP1 as a high affinity complex and repolarizes myeloid derived suppressor cells and M2 macrophages to M1, resulting in production of pronflammatory cytokines such as IFNγ and IL-12, maturation of dendritic cells and induction of tumor specific cytotoxic T lymphocyte immunity. In a prior double-blind Phase II trial in 2nd line non-squamous NSCLC, bavituximab 3 mg/kg plus docetaxel was well-tolerated and demonstrated 60% improvement (11.7 vs 7.3 month) in median overall survival (OS) compared to control. Methods: We accrued 597 patients with Stage IIIb/IV non-squamous NSCLC who progressed on platinum-doublet chemotherapy in a 1:1 ratio to receive up to six 21-day cycles of docetaxel in combination with either weekly 3 mg/kg bavituximab (B + D) or placebo (D) until progression or toxicity. The primary endpoint was OS and secondary endpoints included progression-free survival, overall response rate and safety. Exploratory testing of immune correlatives is ongoing.
| Item Type: | Article |
|---|---|
| Subjects: | Oncology |
| Divisions: | Departments > Department of Oncology and Medical Radiology |
| Depositing User: | Елена Шрамко |
| Date Deposited: | 20 Sep 2017 12:15 |
| Last Modified: | 20 Sep 2017 12:15 |
| URI: | http://repo.dma.dp.ua/id/eprint/1961 |
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