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BerGenBio extends Phase II trial

Clinical trial

The first patient has been dosed in an additional cohort (“Cohort B”) of an ongoing phase II open-label study of BerGenBio’s selective AXL inhibitor bemcentinib in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in previously treated patients with advanced adenocarcinoma of the lung (NSCLC).

The additional cohort of the BGBC008 trial, being run in collaboration with Merck, will extend eligibility to include patients with previously treated advanced NSCLC whose disease is progressing on immunotherapy.

A two-stage design

Patients eligible to participate in Cohort B must have disease progression whilst on a therapy regimen which includes an anti-PD(L)1 inhibitor. The trial follows a two-stage design with the opportunity for an early stop for futility and will evaluate the combination’s objective response rate as a primary endpoint. Comprehensive exploratory studies will evaluate biomarkers in tumour and blood indicative of AXL and PD-L1 expression as well as immune modulation.

“Throughout 2018, we reported encouraging updates from our ongoing proof-of-concept Phase II clinical trial assessing bemcentinib in combination with KEYTRUDA in advanced lung cancer patients post chemotherapy. Patients with AXL positive disease showed particularly good response rates, supporting our belief that selectively inhibiting AXL may act synergistically with immune checkpoint inhibitors in immunotherapy naïve patients. Pre-clinical and translational data strongly suggest that AXL is implicated in anti-PD(L)-1 (checkpoint-inhibitor) therapy failure which has become a large unmet medical need following the rapid uptake of checkpoint inhibitors in first-line lung cancer therapy. Therefore, I am pleased that we are now extending the ongoing trial to test our hypothesis also in patients showing disease progression on checkpoint inhibitors and I look forward to providing updates on both cohorts during 2019,” said Richard Godfrey, Chief Executive Officer of BerGenBio.

Preliminary results from Cohort B are expected in H2 2019. BerGenBio is responsible for conducting the trial. Merck will supply KEYTRUDA for use in the study under a collaboration agreement signed in March 2017.