Bavencio (avelumab) is being developed in collaboration with Pfizer and Merck KGaA. Bavencio, an immunotherapy, was approved by the U.S. Food and Drug Administration (FDA) to treat bladder cancer and Merkel cell carcinoma patients, and is being investigated as a treatment for several other cancers, including non-small cell lung cancer (NSCLC).

How Bavencio works

Bavencio works by encouraging the body’s immune system to target and kill cancer cells.

The immune system can target and destroy infected, abnormal or otherwise damaged cells with the aid of specific white blood cells (or lymphocytes) called cytotoxic T-cells. Cancer cells are aggressive, however, and can evade detection by hijacking a system that also protects healthy cells from being targeted. The immune system has a series of checkpoints that T-cells use to identify a cell as healthy, such as the programmed cell death-1 (PD-1) pathway. This pathway works, or is regulated, in abnormal ways in many NSCLC tumor cells.

Typically, healthy cells produce a ligand — a small molecule that can interact with other proteins, called receptors, which are attached to the outside of cells — called the programmed cell death ligand 1 or PD-L1. This ligand is recognized by the PD-1 receptor produced by T-cells, sending a message not to kill the cell. Some tumors can produce PD-L1, and use the ligand to confuse and evade the T-cells.

Bavencio is a human Ig-G1 monoclonal antibody, or  protein designed to interact with a single target, that specifically targets PD-L1 and prevents it from interacting with PD-1. This enables the T-cells to detect and destroy the cancer cells. It may also induce antibody-dependent cell-mediated cytotoxicity (ADCC), a process by which the binding of an antibody (in particular, human Ig-G1) to a cancer cell targets it for destruction.

Bavencio in clinical trials

The Phase 1 JAVELIN solid tumor clinical trial (NCT01772004) assessed the safety and dosage for Bavencio in a variety of solid tumors, including NSCLC. Of the 184 NSCLC patients included in the trial, 70 (38 percent) achieved stable disease, meaning cancer progression stopped, and 92 (50 percent) had a confirmed response to the treatment. These results were published in the medical journal Lancet Oncology.

Based on these results, Bavencio moved into Phase 3 clinical testing as a first-line treatment in 2015. JAVELIN Lung 100 (NCT02576574) is an open-label trial assessing the response to Bavencio, compared to platinum-based chemotherapy,  in an estimated 1,094 patients with metastatic or recurrent (Stage 4) PD-L1 positive NSCLC. This trial, which is currently enrolling patients at multiple sites worldwide, is expected to end in 2024. Its primary goals, or outcome measures, are progression-free survival (assessed at up to 39 months) and overall survival (assessed at up to 49 months, or about 4 years). Final data are to be collected on these primary measures in April 2019.

Additional information

Bavencio is administered as an injection. The most common adverse effects seen in the clinical trials to date are fatigue, infusion-related reactions, and nausea. Serious adverse effects observed included dyspnea (shortness of breath), pneumonia, and chronic obstructive pulmonary disease.

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