BerGenBio and Merck to evaluate BGB324 with Keytruda in NSCLC and breast cancer

Norwegian-based biopharmaceutical company BerGenBio has signed an agreement to clinically evaluate its lead candidate BGB324 with Merck’s Keytruda (pembrolizumab) in patients with advanced non-small-cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).

BGB324 is a first in class, highly selective, potent and orally available small molecule Axl kinase inhibitor in clinical development in various cancer indications.

Under the agreement, BerGenBio will carry out two international Phase II studies to evaluate the potential clinical synergy of combining the inhibitor with MSD’s anti-PD-1 therapy, Keytruda.

BerGenBio CEO Richard Godfrey said: "This new agreement gives us the opportunity to evaluate the clinical potential of BGB324 in combination with Keytruda in advanced lung and breast cancer; two of the areas of significant unmet medical need.

"We believe the clinical utility of BGB324, in combination with immunotherapies, has enormous potential. BerGenBio is excited to advance BGB324 in combination with Keytruda into Phase II trials and we anticipate results in mid-2018."

"BerGenBio is excited to advance BGB324 in combination with Keytruda into Phase II trials and we anticipate results in mid-2018."

BGBC007 is a Phase II multi-centre study of BGB324 in combination with Keytruda to be conducted in patients with previously treated, locally advanced or unresectable TNBC.

Another Phase II multi-centre study of BGB324 is BGBC008, which would be conducted in combination with Keytruda in patients with previously treated unresectable adenocarcinoma of the lung.

Biomarker studies will also be conducted in a bid to develop companion diagnostics to identify patients who would be suitable for treatment with the BGB324 / Keytruda combination.

At present, BerGenBio is investigating BGB324 in multiple cancer indications based on preclinical and early clinical findings.

The company is developing the Axl inhibitor as a single agent therapy in acute myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS).