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Combination treatment with Opdivo and Yervoy may have better overall survival rates for patients with metastatic uveal melanoma.
Firstline Opdivo (nivolumab) and Yervoy (ipilimumab) showed improvement in overall survival (OS) and manageable toxicity for patients with metastatic uveal melanoma who are ineligible for liver resection, according to data published in Journal of Clinical Oncology.
“Opdivo plus Yervoy showed promising results with a manageable toxicity profile that positions it as a promising first line therapy,”the authors say. Prior to this, those with uveal melanoma had a poor prognosis with an OS of five years for less than 50% of patients with the disease.
The researchers conducted a phase 2 open-label study that took place from April 2016 to June 2017 at nine centers in Spain. The study included 52 patients with a median age of 59.1 years (ranging between 26.1 to 84.3 years), and majority being men, 55.8%. Patients had systemic treatment-naïve, histologically confirmed metastatic uveal melanoma.
The goal of this study was to evaluate the efficacy of Opdivo and Yervoy as a first line therapy for patients with metastatic melanoma who are not eligible for liver resection. The primary endpoint was 12-month OS, and researchers also evaluated progression-free survival (PFS), overall response rate (ORR), and safety.
Patients received treatment of Opdivo at 1 mg once every three weeks and Yervoy at 3 mg every three weeks. After four inductions, patients received 3 mg of Opdivo every two weeks until progressive disease, toxicity or withdrawal. Overall, 78.8% had liver M1, 56% had extra-liver 1, and 32% had elevated lactate dehydrogenase.
Results showed that stable disease was the most common outcome, 51.9%, and was maintained for a median of 3.8 months. Median OS was 12.7 months, with a 12-month rate of 51.9%. and 24-month rate of 26.4%. and PFS was 3.0 months. Researchers associate PFS with high lactic acid dehydrogenase (enzyme that helps produce energy) values.
OS was also shorter in patients with exclusive liver metastasis than those with metastasis in other places beyond the liver (9.2 months versus 23.5 months), and in those with both liver and other metastasis (15.5 months). Authors note that although they had better survival, it was not statistically significant.
“Interestingly, patients with extrahepatic disease, regardless of liver involvement, appear to benefit more from this treatment combination, an observation that should be validated in other studies,” authors note.
Almost all of the patients experienced side effects. The most common were skin related, fatigue, fever, diarrhea and liver related.
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