Bergenbio has announced that its experimental drug, bemcentinib (BGB324), hit the primary endpoint in a stage II trial evaluating it in combination with Keytruda (pembrolizumab) for previously treated advanced non-small cell lung cancer (NSCLC).
The drug succeeded in improving Overall Response Rate (ORR) when in combination with the MSD blockbuster, meeting the target in Cohort A of the Phase II clinical trial.
Specifically, ORR was met in predominantly PD-L1 negative/low patients, and the trial’s secondary endpoint, Progression Free Survival (PFS) exceeded expectations in AXL positive patients.
The success marks bemcentinib as a potential new treatment regimen for previously treated advanced NSCLC, which is any type of epithelial lung cancer other than small cell lung carcinoma (SCLC).
The drug in question, formerly known as BGB324, is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme, currently being evaluated in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent.
Professor Hani Gabra, chief medical officer of BerGenBio commented that he is “impressed” by the results, as they “clearly demonstrate the durable clinical benefits in this difficult to treat low PD-L1 patient population. Importantly the patients that benefit most match gene signatures that predict poor prognosis and a lack of response to immunotherapy in NSCLC”.
The data will be officially presented during at the Society for Immunotherapy of Cancer in the High Impact Clinical Trials session on Friday 8 November in a presentation entitled: A phase II study of bemcentinib (BGB324), a first-in-class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC: Updated analysis.