10-year clinical trial follow-up results show how immunotherapy has changed the outlook for advanced melanoma patients

The CheckMate-067 study has reported its long-term results at the ESMO (European Society for Medical Oncology) Congress in September 2024,10 years after the trial started.1   

Patients have been followed year on year and the results continue to show that nivolumab plus ipilimumab or nivolumab given on its own have benefits on long-term survival of patients, compared to ipilimumab given on its own.  This means that there are patients who are living alongside their advanced melanoma for many years. 

In the CheckMate-067 study, patients who had not had previous treatment for advanced melanoma were randomly put into one of three groups, to receive the following treatments2:  

  • Nivolumab plus ipilimumab every 3 weeks for four doses, followed by nivolumab alone every 2 weeks (nivolumab alone can now be given 4 weekly) 
  • Nivolumab every 2 weeks (it can now be given 4 weekly) 
  • Ipilimumab every 3 weeks for four doses only.  

Treatment was continued until patients’ melanoma progressed (came back), they experienced unacceptable side effects, or if they no longer wanted to take part in the trial. 

The graph shows that more patients who have treatment with ipilimumab and nivolumab (the orange line on the graph) and nivolumab alone (the green line) are living longer. In fact, as these lines plateau (become flatter on the right-hand side), the overall survival or the amount of people alive after 10 years, is around 40% (40 out of every 100 patients) for patients who have had nivolumab and ipilimumab or nivolumab on its own.   

Incredibly, these long-term trial results show that immunotherapy treatments can have a lasting effect in treating melanoma and many patients are living longer.  Treatment choices should take into account the potential side effects of immunotherapies that patients may experience. 

Pembrolizumab is another immunotherapy treatment that is thought to work in a similar way to nivolumab and is given every 3 or 6 weeks and this treatment also results in many patients living alongside their melanoma (similar to nivolumab). A newer combination of treatment with relatlimab-nivolumab was recently approved, and it is thought that long-term results will show that a similar number of patients will live long-term like with the combination of ipilimumab and nivolumab. 

Despite the progress made in the treatment of advanced melanoma, there are still some important questions to be looked at, including finding new treatments or new combinations of treatments with less possible side effects and also better options for patients who do not respond to current immunotherapy treatments. 

References: 

[1]https://www.esmo.org/oncology-news/10-year-data-underscore-how-ici-therapy-has-helped-to-change-the-long-term-prognosis-for-patients-with-advanced-melanoma [Accessed 13/01/2025] 

[2]Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma. Wolchok, JD, et al.  Published September 15, 2024 N Engl J Med 2025;392:11-22. DOI:10.1056/NEJMoa2407417