FDA Approves First Anti-PDL1 Cancer Immunotherapy for Metastatic Lung Cancer

Roche’s biotechnology division, Genentech, has just received US Food and Drug Administration (FDA) approval for their non-small cell lung cancer drug, Tecentriq (atezolizumab). The anti-PDL1 cancer immunotherapy is indicated for patients with tumors containing EGFR or ALK gene abnormities, and those who have experienced disease progression following platinum-containing chemotherapy.

The FDA approval was based on data collected during a Phase II clinical trial – dubbed POPLAR – along with a Phase II study, known as OAK. In the OAK clinical trial, patients taking Tecentriq lived 4.2 months longer than those treated with the standard docetaxel chemotherapy.

“Tecentriq is a new option to help people with this type of previously treated metastatic lung cancer, regardless of PD-L1 expression, live longer than chemotherapy,” said Dr. Sandra Horning, chief medical officer and head of global product development for Genentech. “Tecentriq is the first and only approved cancer immunotherapy designed to target the PD-L1 protein, which may play an important role in the way the medicine works.”

The OAK clinical trial enrolled patients with both squamous and non-squamous types of lung cancer, and did not discriminate based on PD-L1 status. In all, over 15 clinical trials have been conducted to assess Tecentriq, including seven Phase III studies using the immunotherapy as a possible first-line treatment for lung cancer.

Tecentriq is a monoclonal antibody which binds to the PD-L1 protein expressed on certain tumor cells. As an immunotherapy, the drug is designed to stimulate the activation of T cells to detect and destroy cancer cells. The Phase III OAK clinical trial is a global, multicenter, open-label, randomized, controlled study, which compared the safety and efficacy of Tecentriq compared to docetaxel, in 1,225 patients with NSCLC.

“Over the past 15 years, survival rates for advanced lung cancer have been consistently improving,” said Bonnie J. Addario, a lung cancer survivor and founder of the Bonnie J. Addario Lung Cancer Foundation (ALCF). “The approval of Tecentriq is another important step for patients by increasing the number of medicines available to people living with lung cancer.”

Over 224,000 Americans will be diagnosed with lung cancer this year, according to statistics from the American Cancer Society. NSCLC accounts for almost 85 percent of lung cancer cases, with many diagnoses being made once the disease has entered the most advanced stages.