Date: 2017-10-24
Type of
information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: BergenBio (Norway)
Product: BGB324 and pembrolizumab Company:
Action
mechanism:
- molecule inhibitor of the Axl receptor tyrosine kinase that blocks the epithelial-mesenchymal transition, which is a key driver of metastasis and drug-resistance.. Preclinical in vivo studies have shown that BGB324 has both single agent activity in leukemia and solid tumors and is very effective in preventing and reversing acquired resistance to existing therapies including cytotoxics, protein kinase inhibitors and other targeted therapies.
- Keytruda® (pembrolizumab - MK-3475) is an highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, pembrolizumab enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic
area: Cancer - Oncology
Country: Norway, Spain, UK, USA
Trial
details:
- This is an open label, single arm, multi-centre phase II study to assess the anti-tumour activity and safety of bemcentinib (BGB324) in combination with pembrolizumab in up to 48 patients with previously treated advanced adenocarcinoma of the lung. The study will utilise an extension of Simon's 2-stage design. The primary objective is objective response rate. 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. (NCT03184571)
Latest
news:
- • On October 24, 2017, BerGenBio announced 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. Merck & Co will supply Keytruda® 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. It is expected to deliver preliminary results around the end of 2018.
Is
general: Yes
