BMS combination therapy sets new standard in advanced melanoma

Newly released long-term data from a pioneering clinical trial has demonstrated that over 50% of advanced melanoma patients with brain metastases have achieved long-term disease control following treatment with combination immunotherapy as their first-line therapy.

Brain metastases occur in 30-40% of patients diagnosed with stage 4 (advanced) melanoma, which until recently carried a prognosis of survival lasting only around 16 weeks. However, the ABC trial has proven to be a game-changer, marking the first successful use of combination immunotherapy for treating these advanced melanoma patients with BMS’ Yervoy (ipilimumab) and Opdivo (nivolumab). Following the release of early survival data in 2018, the trial’s success has already transformed clinical practice.

The latest 7-year data, published yesterday, highlights the longest follow-up ever for melanoma patients with active brain metastases. The progression-free survival (PFS) rate for patients treated with Yervoy and Opdivo was 42%, compared to just 15% for those treated with Opdivo alone. The overall survival (OS) rates were 48% for the combination therapy and 26% for Opdivo monotherapy.

Notably, when the combination therapy was administered as first-line treatment, the progression-free survival rate rose to 47%, with an overall survival rate of 51%. In comparison, patients treated with Opdivo alone had a 14% progression-free survival rate and 29% overall survival.

“Patients in this long-term study have been followed for seven years now, and the results are fundamentally changing how we think about melanoma that has spread to the brain,” said Professor Grant McArthur AO, who heads Peter Mac’s Molecular Oncology Laboratory and is co-senior author on the study. “A situation that was considered terminal and with very limited treatment options now appears to be curable, based on these new data.”

He further commented, “More broadly, this continues the trend we’ve seen over recent decades as new immunotherapy-based approaches emerge and change advanced melanoma into not only a manageable disease but a curable disease for some patients.”

The randomised, phase 2 study was conducted across four Australian sites: Melanoma Institute Australia, Princess Alexandra Hospital, Royal Adelaide Hospital, and Peter MacCallum Cancer Centre.

Professor Georgina Long AO, Medical Director of Melanoma Institute Australia (MIA) and lead author of the study, said “This proves we have achieved long-term disease control in this group of advanced melanoma patients. We are now confident these patients are cured, a term not used lightly in cancer. This combination immunotherapy should now become standard of care for melanoma patients with brain metastasis.”

Australia, which has the highest melanoma rates in the world, sees one person diagnosed with the disease every 30 minutes, and one person dies from it every 6 hours.

“We have previously shown that with immunotherapy, metastatic melanoma is no longer a death sentence,” said Associate Professor Alex Menzies from MIA and co-senior author on the study.

“This is now the case even for patients with brain metastases, who used to have the worst of the worst prognosis. Results here will not only transform melanoma care but also lead to improvements across the cancer spectrum.”

Professor Long added, “These phenomenal results show the critical importance of investing in research and clinical trials to push science and medicine forward and move us closer to our goal of reaching zero deaths from melanoma.”

Building on these promising findings, the researchers are now advancing the ABC-X trial, an Australia-wide study exploring the role of upfront stereotactic radiosurgery combined with immunotherapy for melanoma patients with brain metastases.

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