The U.S. Food and Drug Administration (FDA) approved Bristol-Myers Squibb‘s Yervoy (ipilimumab), 10 mg/kg, as an adjuvant therapy in patients with resectable Stage III cutaneous melanoma, making it the only immune checkpoint inhibitor approved by FDA for adjuvant therapy for this type of malignancy.
Resectable Stage III melanoma is an aggressive type of malignancy representing about 5% of all novel melanoma cases diagnosed every year. The risk of post-surgical relapse in this melanoma stage is high and dependent on the cancer’s specific substage. But optimal follow-up strategies are now well-defined. Currently, there are few treatment alternatives available to 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, said in a press release. “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 and Opdivo — across multiple tumor types and at many stages of disease.”
FDA’s approval was based on results from a pivotal Phase 3 trial, CA184-029 (EORTC 18071), a collaborative study initiated in 2008 by the European Organization for Research and Treatment of Cancer (EORTC) to evaluate Yervoy 10 mg/kg dose in the adjuvant setting. Results from this trial showed that recurrence-free survival was significantly better with Yervoy 10 mg/kg compared with placebo, reducing by 25% the risk of recurrence or death. The median recurrence-free survival was of 26 months and 17 months for Yervoy and placebo, respectively. Researchers noted that Yervoy may induce several severe to fatal immune-mediated side effects.
Bristol-Myers Squibb is collaborating with the Eastern Cooperative Oncology Group and is conducting an ongoing study to evaluate other doses for Yervoy in the adjuvant setting.
Importantly, Bristol-Myers Squibb is offering a novel program, Adjuvant Patient Program for Melanoma, for patients diagnosed with resected Stage III melanoma (lymph node >1 mm) and treated with Yervoy to ensure their access to Yervoy 10 mg/kg in the adjuvant setting, without payment, for a duration of treatment which may up to three years.