p53-Reactive T Cells Are Associated with Clinical Benefit in Patients with Platinum-Resistant Epithelial Ovarian Cancer After Treatment with a p53 Vaccine and Gemcitabine Chemotherapy
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Abstract
Purpose: To conduct a phase I trial of a Modified Vaccinia Ankara vaccine delivering wild-type human p53 (p53MVA) in combination with gemcitabine chemotherapy in patients with platinum-resistant ovarian cancer. Experimental Design: Patients received gemcitabine on days 1 and 8 and p53MVA vaccine on day 15, during the first 3 cycles of chemotherapy. Toxicity was classified using the NCI Common Toxicity Criteria and clinical response assessed by CT scan. Peripheral blood samples were collected for immunophenotyping and monitoring of anti-p53 immune responses. Results: Eleven patients were evaluated for p53MVA/gemcitabine toxicity, clinical outcome, and immunologic response. Toxicity: there were no DLTs, but 3 of 11 patients came off study early due to gemcitabine-attributed adverse events (AE). Minimal AEs were attributed to p53MVA vaccination. Immunologic and clinical response: enhanced in vitro recognition of p53 peptides was detectable after immunization in both the CD4+ and CD8+ T-cell compartments in 5 of 11 and 6 of 11 patients, respectively. Changes in peripheral T regulatory cells (Tregs) and myeloid-derived suppressor cells (MDSC) did not correlate significantly with vaccine response or progression-free survival (PFS). Patients with the greatest expansion of p53-reactive T cells had significantly longer PFS than patients with lower p53-reactivity after therapy. Tumor shrinkage or disease stabilization occurred in 4 patients. Conclusions: p53MVA was well tolerated, but gemcitabine without steroid pretreatment was intolerable in some patients. However, elevated p53-reactive CD4+ and CD8+ T-cell responses after therapy correlated with longer PFS. Therefore, if responses to p53MVA can be enhanced with alternative agents, superior clinical responses may be achievable. Clin Cancer Res; 24(6); 1315–25. ©2018 AACR.
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Hardwick's group conducted two early-phase clinical trials of MVAp53; MVAp53 induced CD8+ and CD4+ T cell responses in patients with refractory gastrointestinal cancer and ovarian cancer.
“Later in 2014 and 2018, Hardwick’s group conducted two early-phase clinical trials involving a modified vaccinia virus ankara vaccine encoding wtp53 (MVAp53 (253)). The studies showed that MVAp53 could induce CD8+ and CD4+ T cell responses in patients with refractory gastrointestinal cancer and ovarian cancer, respectively.”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [594]
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- Authors
- Hardwick, N. R., Frankel, P., Ruel, C., Kilpatrick, J., Tsai, W., Kos, F., Kaltcheva, T., Leong, L., Morgan, R., Chung, V., Tinsley, R., Eng, M., Wilczynski, S., Ellenhorn, J. D. I., Diamond, D. J., & Cristea, M.
- Affiliations
- Beckman Research Institute (US)
- City Of Hope National Medical Center (US)
- Cedars-Sinai Medical Center (US)
- Corresponding author
- Diamond, Don J.
- ORCID
- Venue
- Clinical Cancer Research
- Published
- 2018-03-14
- Volume
- 24
- Issue
- 6
- Pages
- 1315-1325
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- PMC
- PMC5856606
- OpenAlex
- W2781635391
- Cited by
- 66
- References
- 55
- Citations by year
- 2026: 3 · 2025: 9 · 2024: 7 · 2023: 10 · 2022: 7 · 2021: 11 · 2020: 10 · 2019: 3 · 2018: 5
- FWCI
- 7.75
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Clinical Cancer Research (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- City of Hope Chairs Discretionary Fund and utilized City of Hope Cancer Center (P30CA033572)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian cancer diagnosis and treatment
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Keywords
- epithelial ovarian cancer, platinum resistance, gemcitabine, tumor-infiltrating T cells, CD4+ T cells, CD8+ T cells, regulatory T cells, myeloid-derived suppressor cells, progression-free survival, cancer immunotherapy
- MeSH terms
- Carcinoma, Ovarian Epithelial, Gemcitabine, Adult, Aged, Combined Modality Therapy, Deoxycytidine, Female, Humans, Middle Aged, Neoplasm Metastasis, Neoplasm Staging, Platinum, T-Lymphocytes, Tumor Suppressor Protein p53, Treatment Outcome, Drug Resistance, Neoplasm, Cancer Vaccines
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