Lab Test Available for PD-L1 Levels in Lung Cancer

The complementary laboratory test that measures PD-L1 levels among patients with lung cancer who are to receive treatment with Opdivo® (nivolumab), is now available for commercial use.

Lung cancer is the most common cause of cancer-related deaths in the United States. Opdivo, a PD 1 inhibitor, is an agent that has recently been approved for the treatment of both squamous and non-squamous non-small cell lung cancer.

Opdivo is an immunotherapy agent, which is different than standard chemotherapy. It restores the ability of specific immune cells to recognize and fight cancer cells through the PD 1 receptor pathway.

Opdivo creates its anti-cancer effects by blocking a molecule, referred to as the PD-L1 ligand, from binding to a specific type of immune cell. The PD-L1 ligand reduces the immune cell’s ability to recognize and attack cancer cells through the PD 1 receptor pathway. Through blocking the binding of the PD-L1 ligand, Opdivo restores the immune cells’ ability to recognize and fight the cancer cells.

Clinical studies have demonstrated that patients with higher levels of the PD-L1 ligand tend to achieve greater benefit from treatment with Opdivo, compared to those with lower levels of PD-L1.

The complementary diagnostic test, the PD-L1 IHC 28-8 pharmDx, tests for levels of PD-L1, and is approved by the FDA to be used prior to treatment with Opdivo.

Results from the test are to be used to stimulate discussion between lung cancer patients and their healthcare provider regarding their individual situation and treatment options, not as a definitive determinant for treatment with Opdivo.

The pharmDx test was approved and available to healthcare providers the same time that Opdivo received expanded approval for treatment of lung cancer.

Reference: Quest Diagnostics Press Release. Quest Diagnostics Introduces Dako’s PD-L1 Complementary Diagnostic Test to Support Bristol-Myers Squibb’s OPDIVO® Anti-PD-1 Therapy for Non-squamous Non-small Cell Lung Cancer. The new Quest test service is based on the first FDA-approved complementary diagnostic. Available online at: Accessed November 8, 2015.