The FDA has approved Genentech’s Tecentriq (atezolizumab) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed after platinum-based chemotherapy or whose disease continued after another FDA-approved targeted therapy when their tumors had certain gene abnormalities.
Tecentriq is the first anti-PD-L1 agent to be approved for NSCLC.
“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,” Dr. Sandra Horning, MD, Genentech’s chief medical officer and head of global product development, said in a press release.
The FDA had already approved the anti-PD-1 immunotherapies Opdivo (nivolumab) and Keytruda (pembrolizumab) for the disease.
The Phase 3 OAK study (NCT02008227) compared Tecentriq with the chemotherapy drug Taxotere (docetaxel) in 1,225 patients with locally advanced or metastatic NSCLC and whose disease progressed after platinum-based chemotherapy. The study included patients with both squamous and non-squamous disease types, regardless of their PD-L1 status.
Preliminary data from the first 850 patients enrolled revealed that Tecentriq produced a 4.2-month improvement in patients’ overall survival compared to Taxotere (13.8 months vs. 9.6 months). Objective response rates were similar between both groups, but median duration of response to Tecentriq was more than double that of Taxotere.
Previously, the Phase 2 POPLAR study (NCT01903993) showed a 2.9 month improvement in overall survival in the Tecentriq arm compared to Taxotere (12.6 months vs. 9.7 months).
Primary safety analysis from the POPLAR study showed that the most common adverse reactions from Tecentriq included fatigue, shortness of breath, reduced appetite, cough, nausea, constipation, and muscle pain. Other common adverse events included pneumonia, low levels of circulating oxygen, fatigue, and anemia. Immune-related adverse events included pneumonitis, colitis, hepatitis, and thyroid disease.
“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.”
Tecentriq is also being evaluated in additional clinical trials for lung cancer, including seven Phase 3 studies in previously untreated patients, either alone or in combination therapies.