BerGenBio Announces Start of Randomised Phase I/II Trial Assessing Selective AXL Inhibitor BGB324 in Combination with Current Therapies in Melanoma
Bergen, Norway, May 22 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors to treat multiple cancer indications, 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 highly 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.
*Mutations of the BRAF gene are found in up to 50% of patients with advanced melanoma. The mutation causes cells to grow and spread out of control.
Dr. Oddbjørn Straume, lead investigator of the trial, consultant oncologist at Haukeland University Hospital and principal investigator at the Center for Cancer Biomakers. commented:
“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.”
Comprehensive biomarker programme in collaboration with Norwegian and US investigators.
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. The high degree of innovation, excellent clinical rationale and high scientific value of this trial was recently recognised by generous grant funding by the Norwegian Health Authorities.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented:
“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.”
About BerGenBio ASA
BerGenBio (Bergen, Norway) is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors to treat multiple cancer indications. The Company is a world leader in understanding the central role of AXL kinase in promoting cancer spread, immune evasion and drug resistance in multiple aggressive haematological and solid cancers.
BGB324, is a selective, potent and orally available small molecule AXL inhibitor in Phase II clinical development in four major cancer indications. It is the only selective AXL inhibitor in clinical development. BGB324 is being developed by BerGenBio as a single agent therapy in acute myeloid leukaemia (AML)/myeloid dysplastic syndrome (MDS) and in combination with TARCEVA® (erlotinib) in advanced non-small-cell lung cancer (NSCLC); and in combination with KEYTRUDA® (pembrolizumab) in advanced NSCLC and triple negative breast cancer (TNBC) in collaboration with MSD.
The Company is also developing a diversified pre-clinical pipeline of selective AXL inhibitors including BGB149, anti-AXL monoclonal antibody.
For further information, please visit: www.bergenbio.com
About Investigator-sponsored Trials
Investigator-sponsored clinical trials are clinical trials proposed by front-line patient-facing physicians who act as the regulatory sponsor and are supported by industry in bespoke clinical development partnerships. The industry partner does not assume the role of sponsor according to European or US regulatory guidelines, but may offer support in a variety of different ways, such as providing investigational medicinal product at no cost.
Melanoma is the most serious type of skin cancer as it may spread to lymph nodes and distant organs if not discovered in time. Melanoma occurs when the cells that colour the skin, the so-called melanocytes, start to divide uncontrollably. It is estimated that in 2016, there have been almost 150,000 melanoma diagnoses in the US alone. If detected very early, melanoma has a good prognosis; for patients with advanced melanoma, however, the probability of surviving 5 years or longer is less than 20%.
Straume et al. A Phase Ib/II randomized open label study of BGB324 in combination with pembrolizumab or dabrafenib/trametinib compared to pembrolizumab or dabrafenib/trametinib alone, in patients with advanced non-resectable (Stage IIIc) or metastatic (Stage IV) melanoma. AACR 2017 Abstract. Presented April 2017.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. TARCEVA® is a registered trademark of OSI Pharmaceuticals, LLC., marketed by Genentech/Roche, TAFLINAR® is a registered trademark of Novartis International AG and MEKINIST® is a registered trademark of GSK plc.
CEO, BerGenBio ASA
+47 917 86 304
David Dible, Mark Swallow, Marine Perrier
Citigate Dewe Rogerson
+44 207 638 9571
Forward looking statements
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.