Oncology firm BeiGene has enrolled the first patient in its Phase Ib clinical trial of BGB-283, a second generation B-RAF inhibitor with unique RAF dimer and EGFR inhibiting activity.
BGB-283 demonstrated better anti-tumour activities in preclinical models for cancers with B-RAF V600E mutation, in addition to the non-V600E B-RAF mutation and K-RAS/N-RAS mutations.
The company has designed the study to assess the efficacy of a once daily oral dosing regimen for BGB-283 in solid tumours that harbour B-RAF mutations or aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway.
The Phase Ib trial is being carried out across multiple centres in Australia and New Zealand.
BeiGene CEO John Oyler said: "BGB-283 is a clinically differentiated B-RAF inhibitor able to hit multiple important mutations in the RAS-MAPK pathway.
"The data from the Phase Ia dose escalation study gave us confidence to move into a broad Phase Ib study that is designed to demonstrate BGB-283’s single agent activity across a wide range of solid tumours."
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below formBy GlobalData
BeiGene has started the Phase Ib study following the successful completion of a Phase Ia dose escalation study in patients who have B-RAF or K-RAS mutations.
In the Phase Ia trail, BGB-283 showed a better safety profile along with promising early clinical activity in patients harbouring mutations that previously could not be targeted by first generation B-RAF inhibitors, said BeiGene.
First generation B-RAF inhibitors such as vemurafenib and dabrafenib selectively target mutant B-RAFV600E and have exhibited enhanced clinical activities in melanoma patients with the B-RAFV600E mutation.
These inhibitors received approval to treat patients with B-RAFV600E metastatic melanoma.