Patients with advanced melanoma who must discontinue induction treatment with nivolumab plus ipilimumab because of immune-related adverse events (irAEs) did not have adversely affected overall survival or time to treatment failure, according to the results of a study of non-trial participants published in Clinical Oncology.

The multicenter study included 95 patients with unresectable stage III to IV disease who received first-line combination immunotherapy. The median follow-up was 19.8 months.

The majority of included patients (78.9%) had any grade irAEs and a little less than half (44.2%) had grade 3 to 4 irAEs. Discontinuation due to irAEs occurred in 41.1% of patients.

Continue Reading

The most common irAEs of any grade included colitis (31%), dermatitis (21%), and hepatitis (18%). The most common irAEs leading to discontinuation were colitis and hepatitis.

“Our results, supported by multivariable analysis, suggest a significant association between the development of irAE[s] within the first 3 months of induction treatments and improved survival outcomes,” the researchers stated.

Despite treatment discontinuation, the 12-week landmark overall survival and time to treatment failure were similar between patients who had to discontinue due to irAEs and those who did not, the researchers noted.

In fact, any grade irAEs were associated with a longer overall survival (hazard ratio [HR], 0.35; 95% CI, 0.15-0.82; P =.02) and time to treatment failure (HR, 0.38; 95% CI, 0.17-0.81; P =.01); grade 3 to 4 irAEs were only significantly associated with longer time to treatment failure (HR, 0.45; 95% CI, 0.20-1.01; P =.05).

“Prospective evaluation of whether irAE[s] may be a useful clinical biomarker of treatment response and survival prognostication for patients receiving combination immunotherapy is warranted,” the study authors concluded.

Disclosure: This research was supported by AstraZeneca. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Ksienski D, Truong PT, Wai ES, et al. Survival outcomes following discontinuation of ipilimumab and nivolumab for advanced melanoma in a population-based cohort. Clin Oncol (R Coll Radiol). Published online July 3, 2021. doi:10.1016/j.clon.2021.06.009