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 and can help guide more precise therapy for lung cancer.
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. By blocking the binding of the PD-L1 ligand, Opdivo restores an immune cells’ability to recognize and fight the lung cancer cells.
Not all lung cancer patients respond the same to treatment with Opdivo; 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.
A new diagnostic test, the PD-L1 IHC 28-8 pharmDx, measures the level of PD-L1, and is now approved by the FDA to be used prior to treatment with Opdivo.
Testing for PD-1 can now be used along with other tests including EGFR, and ALK to more precisely guide treatment decisions for lung cancer patients in collaboration with their doctor.
EGFR gene: Mutations in the epidermal growth factor receptor (EGFR) gene may affect how non-small cell lung cancer responds to certain drugs. EGFR contributes to the growth of several types of cancer, and drugs that block the activity of EGFR can slow cancer growth. An EGFR-targeted drug that has been shown to benefit selected patients with non-small cell lung cancer is Tarceva® (erlotinib). Tarceva is currently approved for the treatment of advanced non-small cell lung cancer and as maintenance therapy after chemotherapy.
ALK gene: Up to 7% of non-small cell lung cancers have an abnormal version of the ALK gene that contributes to the growth and development of cancer cells. Xalkori™ (crizotinib) is an oral medication that blocks certain proteins, including the protein produced by this abnormal gene. For advanced non-small cell lung cancers that test positive for the ALK gene abnormality, Xalkori has produced very promising rates of response.
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: http://newsroom.questdiagnostics.com/2015-10-09-Quest-Diagnostics-Introduces-Dakos-PD-L1-Complementary-Diagnostic-Test-to-Support-Bristol-Myers-Squibbs-OPDIVO-Anti-PD-1-Therapy-for-Non-squamous-Non-small-Cell-Lung-Cancer. Accessed November 8, 2015.
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