New clinical trial to study sequencing of melanoma drugs
Dr. Michael Atkins, Deputy Director of Georgetown University Medical Center's Lombardi Comprehensive Cancer Center, will lead a new national clinical trial that compares the sequencing of two groups of melanoma drugs. The study will be conducted by the ECOG-ACRIN Cancer Research Group and will recruit from cancer centers nationwide.
Quoted in a Georgetown press release, Dr, Atkins noted, “After many years of research, we’ve ended up with exciting and effective new combination treatment regimens. Now we need to figure out how to sequence these treatment regimens in order to best extend the lives of our patients.”
Atkins continued, “We have an approved two-drug combination, dabrafenib and trametinib, which works by directly attacking BRAF-mutated melanomas. We also have two immunotherapy options, ipilimumab and nivolumab, each approved for separate use, that work in combination to unleash the body’s own immune system to attack the cancer. The question that remains is which of the two drug combinations should be used first and in whom?”
Read the complete press release.
Combination therapy wins FDA approval
The US Food and Drug Administration has approved the combination of the PD-1 inhibitor Opdivo (nivolumab) and Yervoy (ipilimumab) in the treatment of patients diagnosed with BRAF V600 wild-type unresectable or metastatic melanoma – an indication that was previously given accelerated approval based on clinical trial results.
A Phase 2 study involving 140 participants served as the basis for the recent FDA approval. Those treated with the combined regimen exhibited superior improvements compared to those who received monotherapy with either one of the two immuno-oncology agents. Partial responses were noted in 43% of the group who received the combination therapy versus 11% in the Yervoy monotherapy group. Further, the regimen group showed a 60% reduction in cancer progression risk, with an average PFS of 8.9 months.
According to Jedd D. Wolchok, MD, PhD, Chief, Melanoma and Immunotherapeutics Service, Department of Medicine and Ludwig Center at Memorial Sloan Kettering Cancer Center, the approval "represents a step forward for the melanoma community, providing hope for patients with metastatic melanoma.”
Source: Melanoma News Today