Adjuvant treatment with the immunotherapy drug Opdivo (nivolumab) is superior to Yervoy (ipilimumab) for the management of stage IIIb/c or stage IV melanoma following complete surgical resection. These important results were presented at the European Society for Medical Oncology and published simultaneously in the New England Journal of Medicine.
There remains an unmet need for additional treatment options for individuals with stage III and resected stage IV high-risk melanoma patients because the risk of disease recurrence after surgery is significant. The results from the current clinical trial support Opdivo as a treatment option for these patients with high-risk surgically resected melanoma.
Adjuvant Therapy in Melanoma
Melanoma is separated into five staging categories (stages 0-4). Stage 3 melanoma is a cancer that has spread to the regional lymph nodes but has not yet spread to distant lymph nodes or to other parts of the body (metastasized). Current standard treatment of stage 3 melanoma is surgical resection of the primary tumor as well as the involved lymph nodes. Despite surgical removal of the cancer however, most patients experience disease recurrence and progress to metastatic disease. By five years, the majority of stage IIIb and IIIc patients (68% and 89%, respectively) experience disease recurrence. There remains an unmet need for adjuvant therapy administered following surgery to reduce the risk of the cancer spreading.
Opdivo is a precision cancer medicine that belongs to a new class of medicines called PD-1 inhibitors that have generated great excitement for their ability to help the immune system recognize and attack cancer. PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1 may enhance the ability of the immune system to fight cancer. Opdivo works by blocking PD-1. PD-1 inhibitors are being investigated in more than 30 different cancers, and it is already approved for the treatment of melanoma and lung cancer and researchers continue to evaluate its effectiveness in different types of cancer.
CheckMate -238 is an ongoing clinical trial comparing Opdivo to Yervoy in patients who have undergone complete surgical resection of a Stage IIIb/c or Stage IV melanoma. Overall 906 have been enrolled in the clinical trial and treated with Opdivo or Yervoy.
At this planned interim analysis, Opdivo has demonstrated a significant improvement compared to Yervoy. At 18-month from treatment 66% of Opdivo treated patients survive without cancer progression compared to 54% of those treated with Yervo. The treatment benefit was consistent across key subgroups, including BRAF mutated and BRAF wildtype patients.
Reference: Weber J, Mandala M, Del Vecchio M, et al. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. September 10, 2017DOI: 10.1056/NEJMoa1709030
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