According to a new long-term analysis published in the journal Annals of Oncology, researchers have found that ipilimumab plus fotemustine continue to demonstrate efficacy in patients with metastatic melanoma at 3 years.
The NIBIT-M1 study showed that the combination demonstrated promising activity in patients with metastatic melanoma with or without brain metastases, but now researchers report the long-term efficacy of this combination.
For the study, 86 patients with metastatic melanoma, including 20 with asymptomatic brain metastases, were enrolled. Results showed that with a median follow-up of 39.9 months, the median overall survival for the whole study population was 12.9 months (95% CI: 7.1 - 18.7 months) and the 3-year survival rate was 28.5%.
For those with brain metastases, the median overall survival was 12.7 months (95% CI: 2.7 - 22.7 months) and the 3-year survival rate was 27.8%. In regard to safety, long-term immune-related adverse events consisted of G1 rush and pruritus in 21% of patients. Researchers also found that tumor BRAF-V600 mutational status did not correlate with clinical outcome.
The findings suggest that the combination of ipilimumab plus fotemustine continue to demonstrate efficacy in patients with metastatic melanoma with or without brain metastases after 3 years.
In the NIBIT-M1 study, the authors reported a promising activity of ipilimumab combined with fotemustine in metastatic melanoma (MM) patients with or without brain metastases. To corroborate these initial findings, they now investigated the long-term efficacy of this combination.