FDA Approves Non-Small Cell Lung Cancer Immunotherapy

The FDA has approved atezolizumab (Tecentriq) for the treatment of metastatic non-small cell lung cancer (NSCLC).

Tecentriq is the first and only anti-PDL1 cancer immunotherapy approved by the FDA for metastatic NSCLC. The drug is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors.

“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,” Sandra Horning, MD, Genentech chief medical officer and head of Global Product Development, said 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.”

The approval was based on results from the global, multicenter, open-label, randomized phase 3 OAK study and phase 2 POPLAR study.

OAK evaluated the safety and efficacy of Tecentriq compared with docetaxel. There were 1225 patients with locally advanced or metastatic NSCLC, whose disease progressed following platinum-containing chemotherapy, according to the press release. The primary analysis consisted of the first 850 randomized patients.

Both squamous and non-squamous patients were randomized 1:1 to receive either 1200-mg Tecentriq intravenously every 3 weeks or 75-mg/m2 docetaxel intravenously every 3 weeks. The co-primary endpoints were defined as overall survival (OS) in all patients (intention-to-treat population) and in a PD-L1 selected subgroup in the primary analysis.

The results of the OAK study showed that in the overall study population, Tecentriq helped participants achieve a median survival of 13.8 months, which was 4.2 months longer than those treated with docetaxel (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.74, 95% CI: 0.63, 0.87).

The POPLAR study evaluated the safety and efficacy of Tecentriq compared with docetaxel in people previously treated recurrent locally advanced or metastatic NSCLC. The primary endpoint was OS, with secondary endpoints including progression-free survival, objective response rate, and safety.

Common adverse events were constipation, cough, decreased appetite, dyspnea, fatigue, musculoskeletal pain, and fatigue. Nine participants who received Tecentriq had either pulmonary embolism, pneumonia, pneumothorax, ulcer hemorrhage, cachexia secondary to dysphagia, myocardial infarction, or large intestinal perforation that led to death.

The drug was discontinued in 6 of the 142 patients due to adverse events.

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

Tecentriq can be used in NSCLC patients whose disease has progressed during or following platinum-containing chemotherapy, and progressed on an approved targeted therapy if the tumor contains EGFR or ALK gene abnormalities.

Possible serious side effects include, but are not limited to, pneumonitis, hepatitis, colitis, hormone gland problems, nervous system problems, eye problems, severe infections, and severe infusion reactions.