Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma
Abstract
Purpose: We conducted a retrospective analysis to assess the safety profile of nivolumab monotherapy in patients with advanced melanoma and describe the management of adverse events (AEs) using established safety guidelines. Patients and Methods: Safety data were pooled from four studies, including two phase III trials, with patients who received nivolumab 3 mg/kg once every 2 weeks. We evaluated rate of treatment-related AEs, time to onset and resolution of select AEs (those with potential immunologic etiology), and impact of select AEs and suppressive immune-modulating agents (IMs) on antitumor efficacy. Results: Among 576 patients, 71% (95% CI, 67% to 75%) experienced any-grade treatment-related AEs (most commonly fatigue [25%], pruritus [17%], diarrhea [13%], and rash [13%]), and 10% (95% CI, 8% to 13%) experienced grade 3 to 4 treatment-related AEs. No drug-related deaths were reported. Select AEs (occurring in 49% of patients) were most frequently skin related, GI, endocrine, and hepatic; grade 3 to 4 select AEs occurred in 4% of patients. Median time to onset of select AEs ranged from 5 weeks for skin to 15 weeks for renal AEs. Approximately 24% of patients received systemic IMs to manage select AEs, which in most cases resolved. Adjusting for number of doses, objective response rate (ORR) was significantly higher in patients who experienced treatment-related select AEs of any grade compared with those who did not. ORRs were similar in patients who did and patients who did not receive systemic IMs. Conclusion: Treatment-related AEs with nivolumab monotherapy were primarily low grade, and most resolved with established safety guidelines. Use of IMs did not affect ORR, although treatment-related select AEs of any grade were associated with higher ORR, but no progression-free survival benefit.
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Occurrence of immune-related adverse events (irAEs) is associated with better survival, as suggested by others.
“as suggested by others if there was an occurrence of irAEs [58,59,60].”
From Graves’ Disease during Immune Checkpoint Inhibitor Therapy (A Case Series and Literature Review) (2021) · cites this paper as [59]
In a landmark analysis, immune-related adverse events were associated with better PFS.
“We observed an association between irAEs and improved PFS using a landmark analysis, in agreement with previous studies58–60, and uncovered that baseline gut microbiome composition segregated PD-1-treated patients who developed irAEs from those who did not.”
From Intestinal microbiota signatures of clinical response and immune-related adverse events in melanoma patients treated with anti-PD-1 (2022) · cites this paper as [59]
In general, discontinuation of immune checkpoint inhibitor therapy and subsequent treatment with immunosuppressive agents do not appear to negatively impact patient outcomes.
“In general, discontinuation of ICI therapy and subsequent treatment with immunosuppressive agents do not appear to negatively impact patient outcomes (120, 121).”
From Immune Checkpoint Inhibitors for the Treatment of Cancer: Clinical Impact and Mechanisms of Response and Resistance (2021) · cites this paper as [121]
In that analysis, no differences in PFS were noted between patients who did and did not experience IRAEs based on a landmark PFS analysis.
“No differences in PFS were noted between patients who did and did not experience IRAEs based on a landmark PFS analysis.”
From Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors (2019) · cites this paper as [39]
In that analysis, in a multivariate analysis adjusted for doses of nivolumab, tumor PD-L1 level and baseline LDH, ORR was significantly better in patients who experienced any-grade IRAEs than those who did not (48.6% vs 17.8%, p < .001).
“In a multivariate analysis which adjusted for doses of nivolumab received, tumor PD-L1 level and baseline lactate dehydrogenase levels, ORR was significantly better in patients who experienced any-grade IRAEs than those who did not experience them (48.6% vs 17.8%, p < .001).”
From Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors (2019) · cites this paper as [39]
In a retrospective analysis of 576 melanoma patients pooled from several studies treated with nivolumab, 49% experienced IRAEs.
“Of the patients, 49% experienced IRAEs with the most common IRAE sites being dermatologic (34%), gastrointestinal (13.4%) and endocrine (7.8%).”
From Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors (2019) · cites this paper as [39]
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- Authors
- Weber, J. S., Hodi, F. S., Wolchok, J. D., Topalian, S. L., Schadendorf, D., Larkin, J., Sznol, M., Long, G. V., Li, H., Waxman, I. M., Jiang, J., & Robert, C.
- Affiliations
- Yale New Haven Hospital (US)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2017-03-01
- Volume
- 35
- Issue
- 7
- Pages
- 785-792
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2549481046
- Cited by
- 1,158
- References
- 25
- Citations by year
- 2026: 40 · 2025: 66 · 2024: 96 · 2023: 100 · 2022: 139 · 2021: 169 · 2020: 190 · 2019: 163 · 2018: 136 · 2017: 53 · 2016: 2 · 2015: 2
- FWCI
- 65.33
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Keywords
- nivolumab, advanced melanoma, treatment-related adverse events, immune-related adverse events, immunomodulators, immunotherapy safety, objective response rate, antitumor efficacy, time to onset of adverse events, immune checkpoint inhibitors
- MeSH terms
- Nivolumab, Antibodies, Monoclonal, Antineoplastic Agents, Humans, Melanoma, Retrospective Studies, Skin Neoplasms, Clinical Trials, Phase I as Topic, Clinical Trials, Phase III as Topic
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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