Bristol-Myers Squibb 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 over one-fifth (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).
These nivolumab plus ipilimumab data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017 (abstract #9507).
Melanoma is the most dangerous form of skin cancer and it can be fatal if it has advanced to a stage where it cannot be surgically removed because it has spread to other parts of the body (known as unresectable or metastatic melanoma).
In 2014, around 15,400 people were diagnosed in the UK and approximately 2400 people died from the disease.
Professor John Wagstaff, Professor of Medical Oncology, College of Medicine, Swansea University, said: “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.”
If the disease progresses to the brain, 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,” Prof Wagstaff added.
Faisal Mehmud, Executive Medical Director, Bristol-Myers Squibb UK & Ireland, said: “Bristol-Myers Squibb is very pleased to be sharing these important new data for advanced melanoma patients, whose disease is further complicated by metastasis to the brain.”