24 October 2017
BerGenBio Announces Start of Ph II Trial Assessing Selective AXL Inhibitor BGB324 in Combination with KEYTRUDA® for Patients with Advanced Lung Cancer
Bergen, Norway, 24 Oct 2017 – BerGenBio ASA (OSE: BGBIO) ( http://www.bergenbio.com ), 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 patient has been dosed in a Phase II trial evaluating the Company’s lead product BGB324 in combination with KEYTRUDA® (pembrolizumab) in patients with previously treated advanced adenocarcinoma of the lung (non-small cell lung cancer, NSCLC) whose disease is progressing. The trial is being sponsored by BerGenBio. MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA) will supply KEYTRUDA, an anti-PD-1 therapy, for use in the study under a collaboration agreement signed between the two companies in March 2017. The trial plans to enrol up to 48 patients at hospitals in Norway, Spain, the UK and the US (ClinicalTrials.gov Identifier: NCT03184571).
The clinical study will primarily evaluate the anti-tumour activity, objective response rate, and safety profile of the combination. Additionally, the study will assess the pharmacokinetic profile of BGB324 when given with KEYTRUDA. Comprehensive exploratory studies will evaluate biomarkers in tumour and blood indicative of immune modulation and Axl signalling, including expression levels of PD-L1 and Axl. The trial is expected to deliver preliminary results around the end of 2018.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “This is the second trial under our collaboration agreement with MSD to evaluate the combination of our selective Axl inhibitor BGB324 with MSD’s approved anti-PD-1 therapy, KEYTRUDA. With this study in advanced NSCLC and our other BGB324/KEYTRUDA study in advanced breast cancer, we hope to generate compelling clinical evidence that blocking Axl signalling can reverse and prevent tumour resistance to anti-PD-1 therapies and lead to improved clinical outcomes. The results from these studies and those from our broader Phase II programme with BGB324, which we expect to read-out in 2018, will be crucial to establishing its potential as a key factor in the treatment of many aggressive cancers.”
About NSCLC
It is estimated that more than 220,000 new cases of lung cancer will be diagnosed in the US in 2017 and it is the leading cause of cancer deaths. 65% of NSCLCs are of adenocarcinoma pathology. Although various treatments exist for NSCLC, they are often curtailed by acquired resistance to therapy and immune evasion. Novel treatments overcoming these mechanisms in NSCLC are urgently required.
About BerGenBio ASA
BerGenBio ASA 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 essential role of Axl kinase in mediating cancer spread, immune evasion and drug resistance in multiple aggressive haematological and solid cancers.
BerGenBio’s lead product, BGB324, is a selective, potent and orally bio-available small molecule Axl inhibitor in four Company sponsored Phase II clinical trials in major cancer indications, with read-outs anticipated in the second half of 2018. It is the only selective Axl inhibitor in clinical development.
The Company sponsored clinical trials are:
- BGB324 as a single agent and combination therapy in acute myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)
- BGB324 with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small cell lung cancer (NSCLC)
- BGB324 with KEYTRUDA® (pembrolizumab) in advanced adenocarcinoma of the lung, and
- BGB324 with KEYTRUDA® in triple negative breast cancer (TNBC).
The clinical trials combining BGB324 with KEYTRUDA in adenocarcinoma of the lung and TNBC are conducted in collaboration with Merck & Co. Inc. (MSD), through a subsidiary.
In addition, a number of investigator-sponsored trials are underway, including a trial to investigate BGB324 with either MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial combining BGB324 with docetaxel in advanced NSCLC.
BerGenBio is simultaneously developing a companion diagnostic test to identify patient subpopulations most likely to benefit from treatment with BGB324. This will facilitate more efficient registration trials and support a precision medicine based commercialisation strategy.
The Company is also developing a diversified pre-clinical pipeline of drug candidates, including BGB149, an anti-AXL monoclonal antibody.
For further information, please visit: www.bergenbio.com
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, TARCEVA® is a registered trademark of OSI Pharmaceuticals, LLC., marketed by Roche-Genentech. TAFLINAR® is a registered trademark of Novartis International AG and MEKINIST® is a registered trademark of GSK plc.
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About Oncoinvent
Oncoinvent is developing Radspherin®, a receptor-independent alpha radiation therapy that leverages the unique anatomy of the abdominal cavity to destroy residual micrometastases using a single, highly localized dose of alpha radiation. The initial clinical focus is treatment of ovarian and colorectal cancer patients after surgical removal of the primary tumor and visible metastases in the peritoneum, the thin membrane lining the abdominal cavity and covering the abdominal organs.
This radiopharmaceutical is designed to prevent or delay recurrence in the peritoneal cavity, keeping patients disease-free for longer than the current standard of care and thereby also impacting overall survival. It is broadly applicable to any cancer that spreads to the peritoneum, e.g. ovarian, colorectal, and gastric cancers. Radspherin® stands out for its simplicity, excellent safety profile, and seamless integration into existing surgical workflows. Oncoinvent’s product is easy to use, avoids systemic delivery and significant toxicity. It is also differentiated in being simple to manufacture, scalable, and supply de-risked.
Data from two trials in ovarian (phase 1) and colorectal (phase 1/2a) cancers, are highly promising, showing an excellent safety profile and meaningful signals of efficacy. Interim data from an ongoing, randomized, controlled phase 2 ovarian cancer trial is expected in 2026. With cost-effective manufacturing, blockbuster potential, active pharma partnership momentum, plus strong endorsements from leading experts, Oncoinvent is built for scale and commercial success, and is set to become the new standard for post-surgical cancer care. The Company was founded by the originators of Algeta and Xofigo (acquired by Bayer).
