Victoria Atkinson, MD
Anti–PD-1 monoclonal antibodies, such as nivolumab (Opdivo), will become the backbone of advanced melanoma treatment, predicts Victoria Atkinson, MD, of Princess Alexandra Hospital and Gallipoli Medical Research Foundation in Queensland, Australia.
“Chemotherapy does not have a role in advanced melanoma anymore. PD-1 antibodies, whether combined with BRAF or MEK inhibitors, or other therapies like vaccines or radiotherapy, are the future for the treatment of patients with this disease,” says Atkinson, the lead study author on the phase III CheckMate-066 trial.
The CheckMate-066 trial was the basis of the recent FDA expanded approval, which compared single-agent nivolumab with dacarbazine as a frontline treatment of patients with BRAF wild-type advanced melanoma.
In updated data presented by Atkinson at the 2015 Society for Melanoma Research Congress, the 2-year overall survival (OS) rate with frontline nivolumab was 57.7% compared with 26.7% for dacarbazine. After a minimum follow-up of 15.1 months, the median OS was not yet reached for patients receiving nivolumab compared with 11.2 months in the dacarbazine arm (HR, 0.43; 95% CI, 0.33-0.57; P
<.001). The 1-year OS rates were 70.7% and 46.3% for nivolumab and dacarbazine, respectively.OncLive
spoke with Atkinson regarding the impact of this data and nivolumab’s future as both a monotherapy and in combination with other therapies.
OncLive: How was the trial designed?
: This was a large randomized phase III trial of nivolumab versus dacarbazine in BRAF wild-type patients who had no previous therapy. It was randomized 1:1 to nivolumab or dacarbazine and was also blinded.
At progressive disease, if it was in the patients’ best interest, treatment beyond progression was permitted. The duration of nivolumab was not limited to 2 years; it was allowed until progression or if patients chose not to receive therapy. Patents were stratified by metastasis stage and the treatment was given fortnightly.
What is the significance of this long-term data for patients with melanoma?
This trial is the longest follow-up that we have on patients from a phase III trial with a PD-1 antibody. It shows the highest 2-year survival for any PD-1 therapy in patients with advanced melanoma.
Nivolumab is a highly effective treatment, which is significantly improving the overall survival of patients with good quality of life.