BGB324 (bemcentinib), from BerGenBio, is being developed as a treatment for triple-negative breast cancer, non-small cell lung cancer (NSCLC), acute myeloid leukemia, myelodysplastic syndrome, and metastatic melanoma.

How BGB324 works

BGB324 is an orally administered AXL inhibitor. AXL is a tyrosine kinase receptor, a protein found on the surfaces of some cells, particularly those of the immune system, that fight tumors. It is found at high levels on immune cells in the vicinity of some tumors. AXL strongly suppresses the immune system when activated. It is also present on the surfaces of some tumor cells, making them resistant to immune attacks. BGB324 is designed to inhibit AXL and allow the body’s own immune system to kill tumor cells.

BGB324 in clinical trials

Interim results from four ongoing clinical trials sponsored by BerGenBio were reported at the 2018 ASCO-SITC Clinical Immuno-Oncology Symposium held Jan. 25-27 in San Francisco, California.

The medication’s safety has been evaluated in 34 patients in three Phase 1/2 clinical trials combining BGB324 with Keytruda (pembrolizumab) in triple-negative breast cancer (NCT03184558), advanced NSCLC (NCT03184571), and metastatic melanoma (NCT02872259). Serious adverse events were similar to those reported for Keytruda alone.

A total of 35 patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome received BGB324 alone as part of another Phase 1/2 trial (NCT02488408). Of these 35 patients, two achieved a complete response, and five achieved partial responses. Eight patients reported disease stabilization for more than four months. Three patients were still being studied at the time results were presented. Preliminary results showed that six out of nine patients analyzed showed indications of increased immune activity as a result of AXL inhibition.

Two other trials of BGB324 for treating NSCLC are also ongoing and recruiting participants in the U.S. One is a Phase 1 dose-escalation study of BGB324 in combination with Taxotere (docetaxel) (NCT02922777). The other is a Phase 1/2 trial (NCT02424617) of BGB324 in combination with Tarceva (erlotinib).

Other information

BerGenBio is a Norwegian company dedicated to developing AXL inhibitors for treating multiple aggressive cancers. Inhibition of AXL activity is a novel approach addressing an important mechanism in the evolution of cancer malignancy and aggressiveness.


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