Combination of nivolumab plus ipilimumab can fundamentally change survival expectations.

Bristol-Myers Squibb (BMS) has announced efficacy and safety data from CheckMate -204, the first Phase II study evaluating the cancer immunotherapy combination of nivolumab plus ipilimumab in adult patients with advanced melanoma that has spread to the brain (metastasised).

In this study, 60% of patients treated with combination therapy achieved intracranial (IC) clinical benefit (defined as complete response plus partial response plus stable disease ≥ 6 months). The combination therapy also demonstrated that 21% of patients achieved a complete IC response – meaning there was no detectable sign of the cancer in their brain remaining. Additionally, the data showed that 33% of patients achieved partial responses (significant tumour reduction) and 5% experienced stable disease (no progression in tumour growth). More than 60% of advanced melanoma patients will develop brain metastases, and in these cases, prognosis is poor. These nivolumab plus ipilimumab data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017 (abstract #9507).

"The combination of nivolumab plus ipilimumab has completely transformed how we treat and manage advanced melanoma over recent years and has fundamentally changed survival expectations for these patients," commented Professor John Wagstaff, Professor of Medical Oncology, College of Medicine, Swansea University. "One of the most difficult circumstances in these patients is when the disease progresses to the brain. In these cases, the outlook is generally very poor and treatment limited. These data are therefore really promising and show the potential using immunotherapy can have in wiping out tumours, even in some of the most difficult-to-treat patients."

In the CheckMate -204 study, the IC objective response rate (ORR) was 55% with a median follow-up of 9.2 months. The safety profile of the study was consistent with previously reported data in melanoma patients without brain metastases, and treatment-related grade 3-4 adverse events (AEs) occurred in 52% of patients with 8% being neurologic in nature, including headaches.

"BMS is very pleased to be sharing these important new data for advanced melanoma patients, whose disease is further complicated by metastasis to the brain," said Faisal Mehmud, Executive Medical Director, BMS UK & Ireland. "These patients are often excluded from participating in clinical trials and therefore our knowledge of how these therapies work in such cases has historically been limited. These data confirm that the benefits we have seen in advanced melanoma extend to this difficult-to-treat population. We are committed to furthering our understanding of this cancer and ensuring that all people who may benefit from the combination of nivolumab and ipilimumab are able to do so."