8 October 2018 - - The first patient has been dosed in the second stage of aphase II trial (BGBC008) evaluating Norwegian biopharmaceutical company BerGenBio ASA's (OSE: BGBIO) selective AXL inhibitor bemcentinib in combination with US-based pharmaceutical company Merck's (NYSE: MRK) anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with previously treated advanced adenocarcinoma of the lung (non-small cell lung cancer, NSCLC) whose disease is progressing, the company said.

The trial was advanced into the second stage on the basis that the first stage met its clinical efficacy endpoint (as announced on 26 June 2018). Updated results from the first stage were presented at the 19th Annual World Conference on Lung Cancer (WCLC; 25 September 2018).

The company reported an overall response rate of 40% in patients who tested positive for AXL expression (4 out of 10 pts).

Efficacy was also seen in PD-L1 negative patients (ORR of 27%, 3 out of 11 pts) for whom Keytruda monotherapy is currently not indicated.

Treatment with the bemcentinib/ Keytruda combination was well tolerated.

The second stage will enrol a further 24 patients at sites in Norway, Spain, UK and the US, and aims to confirm the safety and clinical efficacy of the combination. 

Comprehensive exploratory studies will continue to evaluate biomarkers in tumour and blood indicative of AXL expression and immune modulation. Preliminary results from the trial are expected during 2019.

The BGBC008 trial (ClinicalTrials.gov Identifier: NCT03184571) is being sponsored by BerGenBio. MSD, a tradename of Merck and Co., Inc., Kenilworth, New Jersey, USA, will continue to supply KEYTRUDA for use in the study under a collaboration agreement signed in March 2017.

The BGBC008 trial is a phase II multi-centre open-label study of bemcentinib in combination with Keytruda (pembrolizumab) in previously treated, immunotherapy naïve, patients with advanced adenocarcinoma of the lung, the most common form of non-small cell lung cancer (NSCLC).

The objective of the trial is to determine the anti-tumour activity of this novel drug combination and responses will be correlated with biomarker status (including AXL kinase and PD-L1 expression).

BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for advanced and aggressive cancers.

The company's proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme.

Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent.

In parallel, BerGenBio is developing companion diagnostics test to identify patient populations most likely to benefit from bemcentinib; this is expected to facilitate more efficient registration trials and support a precision medicine-based commercialisation strategy.

BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO). www.bergenbio.com

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms that drive aggressive and life-threatening diseases.

In cancer, AXL drives tumour survival, treatment resistance and spread, as well as suppressing the body's immune response to tumours. AXL expression has been established as a negative prognostic factor in many cancers.

AXL inhibitors, therefore, have potential value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities.