Autoimmunity Correlates With Tumor Regression in Patients With Metastatic Melanoma Treated With Anti–Cytotoxic T-Lymphocyte Antigen-4

Attia, Peter; Phan, Giao Q.; Maker, Ajay V.; Robinson, Michael R.; Quezado, Martha M.; Yang, James C.; Sherry, Richard M.; Topalian, Suzanne L.; Kammula, Udai S.; Royal, Richard E.; Restifo, Nicholas P.; Haworth, Leah R.; Levy, Catherine; Mavroukakis, Sharon A.; Nichol, Geoff; Yellin, Michael J.; Rosenberg, Steven A.

doi:10.1200/jco.2005.06.205

Cited by 1,012Cancer Immunotherapy and BiomarkersImmunotherapy and Immune ResponsesCutaneous Melanoma Detection and Management

Autoimmunity Correlates With Tumor Regression in Patients With Metastatic Melanoma Treated With Anti–Cytotoxic T-Lymphocyte Antigen-4

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Attia, Peter, Phan, Giao Q., Maker, Ajay V., Robinson, Michael R., Quezado, Martha M., Yang, James C., Sherry, Richard M., Topalian, Suzanne L. +9 more·2005·Journal of Clinical Oncology

DOI 10.1200/jco.2005.06.205PMC PMC1473965

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Abstract

Purpose: Previously, we reported our experience treating 14 patients with metastatic melanoma using a fully human antibody to cytotoxic T-lymphocyte antigen-4 (anti–CTLA-4) in conjunction with peptide vaccination. We have now treated 56 patients to evaluate two different dose schedules of anti–CTLA-4 and to explore the relationship between autoimmunity and tumor regression. Patients and Methods: A total of 56 patients with progressive stage IV melanoma were enrolled onto the study. All had Karnofsky performance status ≥ 60% with no prior history of autoimmunity. Twenty-nine patients received 3 mg/kg anti–CTLA-4 every 3 weeks, whereas 27 received 3 mg/kg as their initial dose with subsequent doses reduced to 1 mg/kg every 3 weeks. In both cohorts patients received concomitant vaccination with two modified HLA-A*0201-restricted peptides from the gp100 melanoma-associated antigen, gp100:209-217(210M) and gp100:280-288(288V). Results: Two patients achieved a complete response (ongoing at 30 and 31 months, respectively) and five patients achieved a partial response (durations of 4, 6, 25+, 26+, and 34+ months, respectively), for an overall objective response rate of 13%. Tumor regression was seen in lung, liver, brain, lymph nodes, and subcutaneous sites. Of 14 patients with grade 3/4 autoimmune toxicity, five (36%) experienced a clinical response compared with only two responses in the 42 patients (5%) with no autoimmune toxicity (P = .008). There were no significant differences in response rate or toxicity between the two dose schedules. Conclusion: Administration of anti–CTLA-4 monoclonal antibody plus peptide vaccination can cause durable objective responses, which correlate with the induction of autoimmunity, in patients with metastatic melanoma.

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In a prospective study of 56 progressive metastatic melanoma patients treated with ipilimumab, patients who experienced grade 3/4 IRAEs had an improved ORR compared to those who did not (36% vs 5%, p = .008).
“patients who experienced grade 3/4 IRAEs had an improved ORR compared to those who did not experience grade 3/4 IRAEs (36% vs 5%, p = .008) [45].”
From Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors (2019) · cites this paper as [45]

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Autoimmunity in a Phase I Trial of a Fully Human Anti-Cytotoxic T-Lymphocyte Antigen-4 Monoclonal Antibody With Multiple Melanoma Peptides and Montanide ISA 51 for Patients With Resected Stages III and IV Melanoma
Sanderson, K. M., Scotland, R., Lee, P. P., Liu, D., Groshen, S. G., Snively, J., Sian, S., Nichol, G. M., Davis, T. A., Keler, T., et al. (2004) · Journal of Clinical Oncology · doi:10.1200/jco.2005.01.128 · Cited by 432 · see citing works
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Tumor Regression and Autoimmunity in Patients Treated With Cytotoxic T Lymphocyte–Associated Antigen 4 Blockade and Interleukin 2: A Phase I/II Study
Maker, A. V., Phan, G. Q., Attia, P., Yang, J. C., Sherry, R. M., Topalian, S. L., Kammula, U. S., Royal, R. E., Haworth, L. R., Levy, C. L., et al. (2005) · Annals of Surgical Oncology · doi:10.1245/aso.2005.03.536 · Cited by 492 · see citing works
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CTLA‐4 to overcome immunological tolerance to melanoma
Hodi, F. S. (2011) · Asia-Pacific Journal of Clinical Oncology · doi:10.1111/j.1743-7563.2011.01383.x
Cancer regression and autoimmunity induced by cytotoxic t lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma
Phan, G. Q., Yang, J. C., Sherry, R. M., Hwu, P., Topalian, S. L., Schwartzentruber, D. J., Restifo, N. P., Haworth, L. R., Seipp, C. A., Freezer, L. J., et al. (2003) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.1533209100 · Cited by 1,575 · see citing works
Self-citation

Authors: Attia, P., Phan, G. Q., Maker, A. V., Robinson, M. R., Quezado, M. M., Yang, J. C., Sherry, R. M., Topalian, S. L., Kammula, U. S., Royal, R. E., Restifo, N. P., Haworth, L. R., Levy, C., Mavroukakis, S. A., Nichol, G., Yellin, M. J., & Rosenberg, S. A.
Affiliations: National Institutes of Health (US)
ORCID: Phan, Giao Q.
Maker, Ajay V.
Robinson, Michael R.
Quezado, Martha M.
Yang, James C.
Sherry, Richard M.
Topalian, Suzanne L.
Kammula, Udai S.
Restifo, Nicholas P.
Mavroukakis, Sharon A.
Yellin, Michael J.
Rosenberg, Steven A.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2005-09-01
Volume: 23
Issue: 25
Pages: 6043-6053
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2005.06.205
PMC: PMC1473965
OpenAlex: W2151507811
Cited by: 1,012
References: 44
Citations by year: 2026: 6 · 2025: 15 · 2024: 18 · 2023: 17 · 2022: 31 · 2021: 45 · 2020: 81 · 2019: 46 · 2018: 45 · 2017: 55 · 2016: 60 · 2015: 64 · 2014: 49 · 2013: 63 · 2012: 43
FWCI: 30.93
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Institutes of Health (Z99 CA999999)
National Cancer Institute (Z01BC010763)
Topics: Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
Keywords: metastatic melanoma, anti-CTLA-4 monoclonal antibody, CTLA-4 blockade, autoimmunity, autoimmune toxicity, tumor regression, peptide vaccination, gp100, dosing regimen, immune checkpoint inhibitors, objective response rate
MeSH terms: Adult, Aged, Antigens, Differentiation, Drug Administration Schedule, Female, Humans, Immunosuppressive Agents, Injections, Intravenous, Male, Melanoma, Middle Aged, Prognosis, Skin Neoplasms, Autoimmunity, Antigens, CD, Treatment Outcome, Cancer Vaccines, CTLA-4 Antigen

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Autoimmunity Correlates With Tumor Regression in Patients With Metastatic Melanoma Treated With Anti–Cytotoxic T-Lymphocyte Antigen-4

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