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Ipilimumab plus fotemustine demonstrated long-term efficacy in metastatic melanoma
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The combination of ipilimumab and fotemustine demonstrated long-term efficacy in patients with metastatic melanoma, according to extended follow-up results of a phase 2 study.
The NIBIT-M1 study evaluated the combination of ipilimumab (Yervoy, Bristol-Myers Squibb) and fotemustine as first- or second-line treatment for patients with metastatic melanoma.
Initial results suggested promising activity of the combination in this population, including those with or without brain metastases.
For the current analysis, Anna Maria Di Giacomo, MD, of the department of medical oncology and immunotherapy at the University Hospital of Siena, Italy, and colleagues assessed 3-year outcomes.
Outcomes measured included OS, 3-year survival, immune-related PFS, brain PFS and immune-related duration of response.
Researchers correlated clinical results with circulating CD3+, CD4+, ICOS+, CD45RO+ or CD45RA+ T cells, neutrophil/lymphocyte (N/L) ratios and tumor BRAF V600 mutation status.
The analysis included data from 86 patients with metastatic melanoma, including 20 patients with asymptomatic brain metastases. Among the patients with asymptomatic brain metastases, seven were pretreated with radiotherapy.
Median follow-up was 39.9 months.
Median OS for the entire patient population was 12.9 months (95% CI, 7.1-18.7). Median OS was 12.7 months (95% CI, 2.7-22.7) for patients with brain metastases. Three-year survival rates were 28.5% for the entire population vs. 27.8% for patients with brain metastases.
Twenty-one percent of patients experienced long-term immune-related adverse events, including pruritus.
The absolute increase from baseline to week 12 in “memory” T cells identified patients with a better survival (P=.002), but the absolute increase in “naive” T cells in that time period did not predict survival.
The neutrophil-to-lymphocyte ratio correlated with significantly better survival at early time points, researchers wrote. They observed no correlation between BRAF status and clinical outcome.
“Long-term analysis of the NIBIT-M1 trial continues to demonstrate efficacy of ipilimumab combined with fotemustine in metastatic melanoma patients,” Di Giacomo and colleagues wrote. “Fotemustine does not seem to impair the immunologic activity of ipilimumab.”
Disclosure: See the full study for a list of the researchers’ relevant financial disclosures.
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