Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma
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Purpose: To provide a more precise estimate of long-term survival observed for ipilimumab-treated patients with advanced melanoma, we performed a pooled analysis of overall survival (OS) data from multiple studies. Methods: The primary analysis pooled OS data for 1,861 patients from 10 prospective and two retrospective studies of ipilimumab, including two phase III trials. Patients were previously treated (n = 1,257) or treatment naive (n = 604), and the majority of patients received ipilimumab 3 mg/kg (n = 965) or 10 mg/kg (n = 706). We also conducted a secondary analysis of OS data (n = 4,846) with an additional 2,985 patients from an expanded access program. OS rates were estimated using the Kaplan-Meier method. Results: Among 1,861 patients, median OS was 11.4 months (95% CI, 10.7 to 12.1 months), which included 254 patients with at least 3 years of survival follow-up. The survival curve began to plateau around year 3, with follow-up of up to 10 years. Three-year survival rates were 22%, 26%, and 20% for all patients, treatment-naive patients, and previously treated patients, respectively. Including data from the expanded access program, median OS was 9.5 months (95% CI, 9.0 to 10.0 months), with a plateau at 21% in the survival curve beginning around year 3. Conclusion: To our knowledge, this is the largest analysis of OS to date for ipilimumab-treated patients with advanced melanoma. We observed a plateau in the survival curve, beginning at approximately 3 years, which was independent of prior therapy or ipilimumab dose. These data add to the evidence supporting the durability of long-term survival in ipilimumab-treated patients with advanced melanoma.
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Responses to immune checkpoint inhibitors in melanoma and other cancers are heterogeneous and often not durable.
“however responses to these therapies are often heterogeneous and not durable (1–3).”
From Gut microbiome modulates response to anti-PD-1 immunotherapy in melanoma patients (2018) · cites this paper as [1]
The Fig. 2 discussion describes varied outcomes after ipilimumab treatment in advanced melanoma, and reports that only 20%–26% of patients survived to the apparent three-year plateau. This supports heterogeneous outcomes and limited long-term benefit for many patients, but the paper does not establish that initial responses are often lost or extend that finding to other checkpoint inhibitors and cancers. The paper also emphasizes durable survival in a subset. (LLM, conf=0.85)
Experimental — accuracy not yet measuredApproximately 20% of patients who received ipilimumab achieved long-term survival greater than three years, with some patients surviving 10 years.
“Indeed, approximately 20% of patients who received ipilimumab achieved long-term survival greater than three years, with survival of 10 years noted for some patients (38,42).”
From The Next Decade of Immune Checkpoint Therapy (2021) · cites this paper as [42]
The combination of ipilimumab and nivolumab has enhanced response rates in melanoma, lung cancer, renal cell carcinoma, and mismatch repair deficient colon cancer compared with single agent therapy, at the cost of increased toxicities.
“The combination of ipilimumab and nivolumab has demonstrated enhanced response rates in melanoma, lung cancer, renal cell carcinoma, and mismatch repair deficient colon cancer compared with single agent therapy, although at a cost of increased toxicities (see next section).9–11”
From Endocrine toxicities of immune checkpoint inhibitors (2021) · cites this paper as [11]
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- Authors
- Schadendorf, D., Hodi, F. S., Robert, C., Weber, J. S., Margolin, K., Hamid, O., Patt, D., Chen, T.-T., Berman, D. M., & Wolchok, J. D.
- Affiliations
- University of Washington (US)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2015-06-10
- Volume
- 33
- Issue
- 17
- Pages
- 1889-1894
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC5089162
- OpenAlex
- W2133075384
- Cited by
- 2,141
- References
- 23
- Citations by year
- 2026: 54 · 2025: 63 · 2024: 127 · 2023: 149 · 2022: 156 · 2021: 198 · 2020: 204 · 2019: 255 · 2018: 246 · 2017: 276 · 2016: 262 · 2015: 126 · 2014: 22 · 2013: 2
- FWCI
- 132.49
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Amgen
- Bristol-Myers Squibb
- GlaxoSmithKline
- National Institutes of Health
- National Cancer Institute (P30CA008748)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Melanoma and MAPK Pathways
- Keywords
- ipilimumab, metastatic melanoma, unresectable melanoma, overall survival, long-term survival, expanded access program, CTLA-4 blockade, previously treated patients, treatment-naive patients
- MeSH terms
- Ipilimumab, Antibodies, Monoclonal, Antineoplastic Agents, Drug Administration Schedule, Follow-Up Studies, Humans, Melanoma, Prospective Studies, Retrospective Studies, Skin Neoplasms, Treatment Outcome, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Kaplan-Meier Estimate
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