BGB-A317 is an immune checkpoint inhibitor that is currently being investigated both as a monotherapy and as part of a combination therapy to treat various solid tumors and blood-borne cancers. It is being developed by BeiGene, based in Beijing.

How BGB-A317 works

BGB-A317 is an antibody that binds to PD-1, a receptor protein found on the surface of immune cells called T-cells that, when bound by its ligand PD-L1, prevents the activation of T-cells and suppresses an immune system response against damaged or foreign cells.

By binding to PD-1, BGB-A317 removes a block to immune system activation against cancer. In other words, BGB-A317 works by activating and restoring T-cells’ ability to kill cancer cells. Activated T-cells are integral to the treatment of cancer as they help to kill malignant cells.

BeiGene reports that BGB-A317 is different from the existing and approved anti-PD-1 antibodies because of its high affinity and superior target specificity. According to the company, this ability may make BGB-A317 a more potent activator of anti-cancer T-cells and potentially better cancer therapy.

BGB-A317 in clinical trials

BGB-A317 is currently being investigated for its anti-tumor activity in clinical trials taking place around the world.

The safety, tolerability, pharmacokinetics (movement in the body), and treatment effects of BGB-A317 are being investigated in a multicenter, open-label, Phase 1a/1b clinical trial (NCT02407990) in some 450 patients with advanced tumors.

Initial clinical data from the study, announced in 2016, showed that BGB-A317 was well-tolerated and displayed anti-tumor activity in a number of advanced solid tumors. Preliminary Phase 1 data of the study, released in June 2017, revealed that BGB-A317 demonstrated anti-tumor activity in patients diagnosed with advanced hepatocellular carcinoma (HCC) or liver cancer. The data presented was from 40 patients diagnosed with HCC, and the study itself is set to conclude in March 2018.

The efficacy of BGB-A317 is also being evaluated in combination with other treatments to explore their potential in cancer patients. For example, the safety, pharmacokinetics and anti-tumor activity of BGB-A317 in people with advanced solid tumors are currently being investigated in a Phase 1 study (NCT02660034) in combination with BGB-290, a compound that has demonstrated effectiveness at inhibiting tumor cell growth. The study, taking place in Australia and New Zealand, is expected to conclude in September 2019.

The efficacy of BGB-A317 as a monotherapy in people with Hodgkin’s lymphoma that has returned or did not respond to other treatments is currently being investigated in a single-arm, multicenter Phase 2 clinical trial (NCT03209973). The primary goal of the study is patients’ overall response rate. A secondary outcome measure is the progression-free survival rate of patients up to two years after given a first dose of BGB-A317 to the date of disease progression or death. This study, which is being conducted primarily in China, is expected to be finish in early 2019.

Another Phase 1 study (NCT02795182), taking place in Australia, is evaluating BGB-A317 plus BGB-3111 to assess the safety and preliminary efficacy of the combination therapy in people with B-cell lymphoid malignancies, such as many non-Hodgkin’s lymphomas. BGB-3111 is a potent and highly selective small molecule that has the ability to kill malignant B-cells. The study is set to conclude in December 2019.

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