The drug is specifically indicated for NSCLC patients whose disease progressed during or following platinum-containing chemotherapy, or during an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.
Tecentriq is a monoclonal antibody targeting a protein called PD-L1 (short for programmed death-ligand 1), whose expression is increased in tumor cells to protect these cells from the cytotoxic action of the immune system.
FDA’s approval is based on the latest positive results of the randomized Phase 3 OAK (NCT02008227) and Phase 2 POPLAR (NCT01903993) studies. The OAK clinical trial investigated the effectiveness and safety of Tecentriq relative to the chemotherapy drug Taxotere (docetaxel). Researchers showed that Tecentriq improved patients’ overall survival, helping them live a median of 13.8 months, 4.2 months longer than those treated with Taxotere.
Patients with both squamous and non-squamous disease types were included in the OAK study independently of their PD-L1 status.
The POPLAR study, a randomized Phase 2 trial, evaluated the effectiveness and safety of Tecentriq compared with Taxotere chemotherapy (docetaxel) in people with previously treated recurrent locally advanced or metastatic NSCLC. Here, Tecentriq was also shown to enhance patients’ overall survival.
“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, MD, chief medical officer and head of Genentech’s Global Product Development, in a press release.
“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.”
“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,” she said.
Lung Disease News had the opportunity to obtain a comment about Tecentriq’s approval from Dr. Roy Herbst, chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital, and associate director for translational research at Yale Cancer Center.
“The approval of Tecentriq – the first and only anti-PDL1 cancer immunotherapy – is important because there is a significant need for new treatment options for lung cancer, which is still the leading cause of cancer deaths in the U.S. despite recent advances,” Herbst wrote to Lung Disease News. “The approval is in part based on results from a Phase III study that showed Tecentriq helped people with previously treated metastatic non-small cell lung cancer live significantly longer compared with those who received chemotherapy.”
“As an oncologist, this is encouraging news and provides hope to many of my patients with this devastating disease. This is especially exciting for me as we did the very first Phase I trial at Yale over four years ago with patients still alive,” Herbst added.