Is There a New Standard Way to Treat Advanced-Stage Melanoma?

Ongoing research within the advanced-stage melanoma therapeutic space is beginning to suggest that shorter treatment periods may be sufficient for some patients, challenging the current standard-of-care consisting of a two-year duration of immunotherapy, according to Dr. Vincent Ma.

To delve further into this topic, he sat down for an interview with CURE, in which Ma discussed recent trial data which were shared at the 2025 ASCO Annual Meeting that looked at this research question. He went on to say that based on this ASCO data, definitive conclusions cannot yet be drawn.

Ma is an assistant professor and faculty member in the Division of Hematology, Medical Oncology and Palliative Care within the Department of Medicine and a faculty affiliate of the Department of Dermatology, all at the University of Wisconsin, School of Medicine and Public Health.

Transcript:

One of the interesting studies presented this year was the DANTE trial. This was a phase 3 study examining whether two years of immunotherapy — the current standard minimum — is more effective than one year for patients with advanced-stage melanoma.

To provide some background, the current standard for treating advanced-stage melanoma involves a minimum of two years of treatment because that's how these drugs were studied in large-scale clinical trials. However, both providers and patients often wonder if two years of treatment is truly necessary. Two years of therapy can be a significant burden for patients, who must take time off from work every three to four weeks for treatment. There's no clear biological or scientific rationale for a two-year duration; some patients respond to treatment after only a few doses, and the effects of immunotherapy can even persist after treatment stops. This was the basis for the DANTE trial: to determine if two years of treatment is truly needed, or if one year of therapy could be sufficient.

The study was primarily conducted in the United Kingdom, with an initial goal of enrolling 1,200 patients. Unfortunately, the study had to close after several years, accruing only 166 patients in total. Therefore, the study was considered underpowered, meaning it didn't reach the target number of patients needed to statistically prove if one year versus two years yielded the same or better results. The study's goal was to prove that one year was non-inferior to two years.

What the study did find was that, overall, one year of treatment was not statistically inferior to two years of therapy in terms of progression-free survival. This suggests that we could potentially reduce treatment to one year instead of two. However, due to the study being underpowered, the investigators concluded that the standard of care should remain a minimum of two years of immunotherapy for patients with advanced-stage melanoma.

One crucial question the study did not fully answer is the overall survival outcomes between two years versus one year, and this remains an unanswered question. Nonetheless, other studies are currently underway that are exploring the role of giving less therapy based on how patients respond to treatment. Therefore, this is neither the first nor the last time we'll hear about a study investigating the proper duration of immunotherapy for patients with advanced-stage melanoma.

Transcript has been edited for clarity and conciseness

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