BeiGene begins dosing in Phase Ib trial of BGB-283 to treat solid tumors

Being conducted across multiple centers in Australia and New Zealand, the trial will determine the efficacy of a once daily oral dosing regimen for BGB-283 in solid tumors that harbor B-RAF mutations and/or aberrations in the RAS-MAPK pathway.

The Phase Ib trial follows the successful completion of a Phase Ia dose escalation study in patients who have B-RAF or K-RAS mutations.

In the Phase Ia trial, BGB-283 showed a good safety profile along with promising early clinical activity in patients harboring mutations that previously could not be targeted by first generation B-RAF inhibitors.

BeiGene CEO John Oyler said: "We have continued to make great progress across all our clinical development programs.

"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 tumors."

The company said that first generation B-RAF inhibitors including vemurafenib and dabrafenib selectively target mutant B-RAFV600E and have exhibited remarkable clinical activities in melanoma patients with the B-RAFV600E mutation.

They are approved to treat patients with B-RAFV600E metastatic melanoma.

However, first generation B-RAF inhibitors have limited clinical activity outside of melanoma with B-RAFV600E mutation.