Bristol-Myers Squibb’s Opdivo, which is being investigated as adjuvant treatment after surgery for stage IIIb/c or IV melanoma patients at high risk of recurrence, may significantly cut the risk of patients’ cancer returning at 24 months versus Yervoy.
According to data from the Phase III CheckMate-238 study, presented at this year’s American Society of Clinical Oncology meeting, at 24 months nearly two thirds (63 percent) of patients treated with Opdivo (nivolumab) had longer recurrent-free survival, compared to those treated with Yervoy (ipilimumab; 50 percent) regardless of BRAF mutation status.
The drug also showed an advantage on tolerability, showing a lower rate of serious adverse events (AEs) of any grade compared to Yervoy (17.5 percent versus 40.4 percent, respectively) after 18 months’ treatment.
Neither Opdivo nor Yervoy are currently licensed in Europe for adults with melanoma stage IIIb/c or IV who are at high risk of recurrence following complete surgical resection.
Professor John Wagstaff, Professor of Medical Oncology, College of Medicine, Swansea University and UK trial investigator, said the data for Opdivo represent “a significant advance in how we could help prevent recurrence of this potentially deadly disease.”
He added: “With many melanoma patients being relatively young, it is critical treatment options are available for patients that could help to overcome their disease. These data show the potential for nivolumab in this patient group.”
The “landmark data” could represent “a significant step forward for patients”, who can be left with limited treatment options after surgery, including the highly stressful ‘watch and wait’ scenario which involves monitoring patients for recurrence, noted Gill Nuttall, chief executive and founder of Melanoma UK.
The incidence of melanoma in the UK has more than doubled in the last 20 years, where between 2013-2015, around 15,400 people were diagnosed with the condition every year.
European regulators approved a combination of Opdivo and Yervoy in 2016 for the treatment of advanced melanoma in adults, on data showing median progression free survival of 11.5 months for combination, 6.9 months for Opdivo, and 2.9 months for Yervoy.