A new clinical trial is underway assessing the addition of the first-in-class AXL kinase inhibitor, BGB324, to standard of care treatment for patients with advanced unresectable or metastatic melanoma.
The Phase 1/2 clinical trial (NCT02872259) was announced by BerGenBio, a clinical-stage biopharmaceutical company that focuses on the role of AXL kinase in promoting cancer spread, cancer cell immune system evasion, and drug resistance.
The study, sponsored by Haukeland University in Bergen, Norway, plans to enroll up to 92 patients with advanced melanoma from several Norwegian hospitals.
Patients who meet inclusion criteria will be randomized into one of two different groups depending on their tumor load and BRAF mutational status. BRAF mutations are found in up to 50% of patients with advanced melanoma and are one of the mutations responsible for rapid cell growth.
Patients without BRAF mutations, or with a BRAF mutation and low tumor load, will receive Keytruda (pembrolizumab) with or without BGB324. Patients with a BRAF mutation and high tumor load will receive Tafinlar (dabrafenib) and Mekinist (trametinib) with or without BGB324.
The study endpoints include objective response rate, progression-free survival, duration of response, and overall survival.
“Immune checkpoint inhibitors, such as the anti-PD-1 therapy pembrolizumab, and targeted therapy against BRAF, such as the MAP Kinase inhibitors dabrafenib and trametinib, which have recently been introduced to treat metastatic melanoma have created considerable excitement due their high initial response rates as well as durable responses in a small fraction of cases,” Oddbjørn Straume, MD, PhD, who is lead investigator of the trial, an oncologist at Haukeland University Hospital, and lead investigator at the Center for Cancer Biomarkers, said in a press release. ”However, the development of treatment resistance in patients is common and as a result we are urgently looking at combination strategies to further improve patient outcomes.”
In 2016, some 150,000 new cases of melanoma were diagnosed in the U.S. If detected early, patients have a good prognosis.
Straume stated that future studies would also seek to assess the role of BGB324 in the treatment of advanced lung cancer and triple-negative breast cancer.