Axl Inhibitor BGB324 in Combination With Trametinib Plus Dabrafenib or Pembrolizumab in Advanced Melanoma

BerGenBio ASA announced that the randomized phase Ib/II clinical study of the Axl inhibitor BGB324 in combination with either the MAP kinase inhibitors trametinib (Mekinist) plus dabrafenib (Tafinlar) or the immune checkpoint inhibitor pembrolizumab (Keytruda) in patients with advanced melanoma is recruiting well at four sites in Norway and reports a favorable safety profile. The results and analysis from this dose-finding part of the study were presented in a poster at the 9th World Congress of Melanoma in Brisbane, Australia.

Oddbjørn Straume, MD, PhD, consultant oncologist at Haukeland University Hospital and Professor at the University of Bergen Centre for Cancer Biomarkers and sponsor of the trial, reported that the recommended phase II dose of BGB324 in combination with trametinib and dabrafenib had been established. In addition, Dr. Straume presented early data demonstrating that BGB324 is well tolerated in combination with either dabrafenib and trametinib or pembrolizumab.

Patient recruitment in all three arms of the phase II study is ongoing and seeks to demonstrate safety and efficacy of BGB324 in combination with pembrolizumab or dabrafenib and trametinib in the first-line and second line setting. A parallel biomarker study is ongoing in collaboration with Massachusetts Institute of Technology and Harvard Medical School.

Dr. Straume commented, “Although novel immune and targeted therapies show high initial response rates, they are curtailed by the development of treatment resistance. Combination strategies … are being widely explored to further improve patient outcomes. Axl is a combination target of particularly high interest, as it has been shown to be a key driver of resistance in melanoma to both [anti–programmed cell death protein 1 (anti–PD-1)] therapy and MAP kinase inhibitors as well as playing a role in antitumor immune suppression. BGB324 is the most advanced selective Axl inhibitor in clinical development. It is very encouraging to see that BGB324 thus far has been tolerated well in patients with metastatic melanoma, and I look forward to continue enrolling patients into the randomized arms of the study.”

Richard Godfrey, Chief Executive Officer of BerGenBio, said, “We greatly appreciate the opportunity to work with physician-scientists at the forefront of their research areas such as Dr. Straume and his international collaborators. This randomized trial in patients with melanoma is of great interest as it explores BGB324 as a potential cornerstone therapy across the whole patient population. BGB324 has specifically been developed as a selective Axl inhibitor to allow such strategic combinations and we are encouraged by the strong patient recruitment and that the combination with the MAP kinase inhibitors or the anti–PD-1 therapy pembrolizumab so far has been well tolerated. This is especially important as we advance two additional phase II studies of BGB324 in combination with pembrolizumab in lung and breast cancer.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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