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Evaluation of Ipilimumab in Combination With Allogeneic Pancreatic Tumor Cells Transfected With a GM-CSF Gene in Previously Treated Pancreatic Cancer
Open accessAbstract
Preclinical reports support the concept of synergy between cancer vaccines and immune checkpoint blockade in nonimmunogenic tumors. In particular, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies have been successfully combined with GM-CSF cell-based vaccines (GVAX). Ipilimumab (anti-CTLA-4) has been tested as a single agent in patients with pancreatic ductal adenocarcinoma (PDA) resulting in a delayed response at a dose of 3 mg/kg. Our study evaluated ipilimumab 10 mg/kg (arm 1) and ipilimumab 10 mg/kg + GVAX (arm 2). A total of 30 patients with previously treated advanced PDA were randomized (1:1). Induction doses were administered every 3 weeks for a total of 4 doses followed by maintenance dosing every 12 weeks. Two patients in arm 1 showed evidence of stable disease (7 and 22 wk) but none demonstrated CA19-9 biochemical responses. In contrast, 3 patients in arm 2 had evidence of prolonged disease stabilization (31, 71, and 81 wk) and 7 patients experienced CA19-9 declines. In 2 of these patients, disease stabilization occurred after an initial period of progression. The median overall survival (OS) (3.6 vs. 5.7 mo, hazards ratio: 0.51, P = 0.072) and 1 year OS (7 vs. 27%) favored arm 2. Similar to prior ipilimumab studies, 20% of patients in each arm had grade 3/4 immune-related adverse events. Among patients with OS > 4.3 months, there was an increase in the peak mesothelin-specific T cells (P = 0.014) and enhancement of the T-cell repertoire (P = 0.031). In conclusion, checkpoint blockade in combination with GVAX has the potential for clinical benefit and should be evaluated in a larger study.
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“To overcome these obstacles and induce an antitumor T cell response, recent trials have combined GVAX (an allogeneic whole cell vaccine, composed of 2 cell lines genetically modified to secrete granulocyte macrophage CSF) with immune checkpoint inhibitors ipilimumab (6) (targeting CTLA-4) or nivolumab (7) (targeting P…”
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Metadata
- Authors
- Le, D. T., Lutz, E., Uram, J. N., Sugar, E. A., Onners, B., Solt, S., Zheng, L., Diaz, L. A., Donehower, R. C., Jaffee, E. M., & Laheru, D. A.
- Venue
- Journal of Immunotherapy
- Published
- 2013-09
- Volume
- 36
- Issue
- 7
- Pages
- 382-389
- ISSN
- 1524-9557 (ISSN-L)
- OpenAlex
- W2324865626
- Cited by
- 564
- References
- 0
- FWCI
- 22.92
- Type
- journal article
- Language
- en
- Open access
- green
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