Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has approved Yervoy (ipilimumab) 10 mg/kg for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection including total lymphadenectomy. This approval is based on clinical data from a pivotal Phase 3 trial, CA184-029 (EORTC 18071), which demonstrated Yervoy 10 mg/kg significantly improved recurrence-free survival (RFS) vs. placebo in this setting, with a 25 percent reduction in the risk of recurrence or death. The median RFS was 26 months (95% CI: 19, 39) for Yervoy vs. 17 months (95% CI: 13, 22) for placebo (hazard ratio [HR]=0.75; 95% CI: 0.64, 0.90; p<0.002). Yervoy is the first and only FDA-approved immune checkpoint inhibitor in the adjuvant treatment for fully resected Stage III melanoma (lymph node >1 mm).
Resectable, Stage III melanoma represents 5 percent, or approximately 3,100 cases, of all new melanoma cases diagnosed annually. This stage of melanoma can be aggressive, with a 60 percent risk of recurrence after surgery. Despite the risk of disease recurrence among Stage III melanoma patients following resection, there are limited treatment options available to help reduce the risk of recurrence after surgery.
“The science of Immuno-Oncology is rapidly advancing, and we are proud to be the first to demonstrate the potential of an immune checkpoint inhibitor in the adjuvant setting, an earlier stage of the disease, where patients urgently need new medicines,” said Michael Giordano, M.D., senior vice president, head of Development, Oncology, Bristol-Myers Squibb. “The approval of Yervoy for the treatment of adjuvant melanoma underscores our scientific leadership in Immuno-Oncology, with a commitment to further developing our I-O agents – Yervoy andOpdivo – across multiple tumor types and at many stages of disease.”
Yervoy is associated with a Boxed Warning and can result in severe to fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. Please see below for additional Important Safety Information, including Boxed WARNING regarding immune-mediated adverse reactions.
This Phase 3 trial, CA184-029 (EORTC 18071), is a cooperative group study initiated in 2008 by the European Organization for Research and Treatment of Cancer (EORTC) evaluating the 10 mg/kg dose in the adjuvant setting. With the goal of advancing treatment options for the adjuvant treatment of melanoma, Bristol-Myers Squibb is working with the Eastern Cooperative Oncology Group (ECOG) and is conducting an ongoing study to investigate other dosing options for Yervoy in the adjuvant setting.
“Today’s approval is an important step in our commitment to bring our Immuno-Oncology pipeline to earlier lines of cancer treatment and to make new options available quickly while we continue to build upon our scientific understanding and develop even better solutions,” continued Giordano. “Bristol-Myers Squibb has broad development programs in the adjuvant setting across multiple tumors, including the ongoing studies of
Opdivo and of
Yervoy in adjuvant melanoma.”