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BerGenBio starts Phase I/II trial


BerGenBio announces that the first patients have been dosed and continue on therapy in a Phase I/II randomised trial evaluating the addition of BerGenBio’s selective, potent and orally bio-available AXL inhibitor BGB324 to standard of care treatments in patients with advanced, non-resectable or metastatic melanoma.

The trial, which is sponsored by Haukeland University Hospital (Bergen, Norway), with the support of BerGenBio, plans to enrol up to 92 melanoma patients from several Norwegian hospitals. Patients recruited into the study will be randomised based on their tumour load and BRAF mutational status to receive either:

Pembrolizumab (KEYTRUDA) +/- BGB324, or
Dabrafenib (TAFINLAR) and trametinib (MEKINST) +/- BGB324
Endpoints of the study are objective response rate as well as 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. 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. AXL has been shown to be a key driver of resistance in melanoma to both anti-PD-1 therapy and MAP kinase inhibitors. This is why we believe combinations that include the selective AXL inhibitor BGB324 could hold great promise for a wide range of patients with non-resectable or metastatic melanoma. Consequently, I appreciate the opportunity to offer my patients access to the investigational AXL inhibitor BGB324 in this Phase Ib/II clinical trial and look forward to drive the opening of additional trial sites across Norway later this year,” said Dr. Oddbjørn Straume, lead investigator of the trial, consultant oncologist at Haukeland University Hospital and principal investigator at the Center for Cancer Biomakers.

Biomarker program

In parallel with the clinical trial, leading Norwegian experts in treating melanoma together with collaborators at Massachusetts Institute of Technology and Harvard Medical School (Boston, USA) are conducting a comprehensive programme of explorative biomarker analyses.

“We congratulate Dr. Straume on the start to this exciting study, which we believe is highly representative of real world practice for treating advanced melanoma. We and others have published encouraging research showing AXL’s role in driving mechanisms that enable tumour cells to go unnoticed by the immune system and also to build resistance to therapies, as well as the potential of BGB324 to counteract these traits of tumour aggressiveness in a wide range of cancers. Based on these data we see a clear rationale for combining our first-in-class AXL inhibitor BGB324 with immune checkpoint blockade or targeted agents in multiple cancer indications. We look forward to results from this new study, as well as from further combination studies we have planned with BGB324 and pembrolizumab in advanced lung cancer and triple negative breast cancer, which we are intending to start in the near future,” Richard Godfrey, Chief Executive Officer of BerGenBio, commented.