FDA Approves Combination Therapy For BRAF Wild-Type Unresectable or Metastatic Melanoma

FDA Approves Combination Therapy For BRAF Wild-Type Unresectable or Metastatic Melanoma

Bristol-Myers Squibb recently announced the approval by the U.S. Food and Drug Administration (FDA) of its combination therapy, Opdivo (nivolumab) with Yervoy (ipilimumab), for BRAF V600 wild-type unresectable or metastatic melanoma. This is the first combination therapy of two immuno-oncology drugs approved by the FDA.

The approval is the result of findings from the phase II study CheckMate-069, which enrolled 140 patients with untreated unresectable or metastatic melanoma, and included BRAF wild-type and BRAF mutation-positive melanoma patients. This therapy is a combination of immune checkpoint inhibitors that target two separate tumor immune checkpoints involved in cancer growth: Opdivo is a PD-1 inhibitor that restores T cell responses against the tumor and Yervoy blocks CTLA-4, leading to activation and proliferation of T cells. Both drugs are FDA approved as single therapy drugs for the same diseases, and Opdivo is also approved to treat non-small cell lung cancer.

Results from the study show that, compared to Yervoy monotherapy, the combination therapy had a significantly higher response for patients with BRAF wild-type melanoma (109), 60% vs the 11 % obtained in the monotherapy regimen. A total of 17% of BRAF wild-type patients experienced a complete response and 43% responded partially to the conjugation therapy. Furthermore, the combination therapy reduced in about 60% risk of progression when compared to Yervoy alone. Seventy-nine percent of patients had ongoing responses of at least 6 months at the time of analysis. Of these patients, 14 had a duration of response of at least 6 months but less than 9 months, and 20 patients had a duration of response of at least 9 months. The remaining 9 (21%) patients had a response duration ranging from 3 to 7 months.  Importantly, serious adverse reactions were experienced by 62% of patients in combination therapy versus 39% of those in Yervoy alone.

Jedd D. Wolchok, MD, PhD, Chief, Melanoma and Immunotherapeutics Service, Department of Medicine and Ludwig Center at Memorial Sloan Kettering Cancer Center, commented on these results and on what this approval means for melanoma patients, “Historically, metastatic melanoma has been a difficult disease to treat.Now, a new treatment option based on the combination of two valued Immuno-Oncology agents demonstrates significant efficacy versus ipilimumab (Yervoy) in metastatic melanoma,” concluding that “Today’s approval represents a step forward for the melanoma community, providing hope for patients with metastatic melanoma.”

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