Bristol-Myers Squibb has announced significant (RFS) results from an ongoing Phase III study evaluating nivolumab versus ipilimumab in patients who have undergone complete resection (surgical removal) of stage IIIb/c or stage IV melanoma.
In the study (involving 906 patients), treatment with nivolumab resulted in significant improvement of 35% in RFS (length of time after initial treatment with no sign of the cancer returning) compared with ipilimumab.
The 18-month RFS rate for nivolumab was 66%, compared to 53% in patients treated with ipilimumab.
These investigational data were presented at the European Society for Medical Oncology (ESMO) 2017 Congress, (Abstract #LBA5646) and will be simultaneously published in the New England Journal of Medicine.
Melanoma is the most dangerous form of skin cancer. When patients are diagnosed with stage III disease, this means it has not yet spread to distant lymph nodes or other parts of the body. At stage IV it is advanced and the melanomas have spread elsewhere in the body, away from where they started (the primary site) and the nearby lymph nodes. To remove the tumour and any spread to the nearby lymph nodes, patients initially undergo surgery.
Mark Middleton, Professor of Experimental Cancer Medicine at The University of Oxford and Consultant Medical Oncologist at the NIHR Oxford Biomedical Research Centre, said: “These new data showing the impact of nivolumab on stopping the melanoma coming back after surgery show how we might use the drug earlier in the course of the disease.”
Faisal Mehmud, Executive Medical Director, Bristol-Myers Squibb UK & Ireland, said: “Nivolumab is the first anti-PD-1 to improve recurrence free survival in these patients, coupled with an improved tolerability profile versus ipilimumab. These results presented today speak to our leadership and commitment to cancer research and offer potential for much-needed additional treatment options in earlier stages of this disease.”