NEW YORK – Genentech announced on Tuesday that its immunotherapy atezolizumab (Tecentriq) was approved by the US Food and Drug Administration as a first-line option for adult patients with metastatic non-squamous non-small cell lung cancer who don't harbor EGFR or ALK genomic tumor aberrations.
The approval is based on data from the Phase III IMpower130 study, which showed that in combination with chemotherapy, atezolizumab significantly prolonged median overall survival compared to treatment with standalone chemotherapy, 18.6 months versus 13.9 months, respectively. Patients on the atezolizumab-chemotherapy combination also experienced longer median progression-free survival compared to those treated with only chemotherapy, 7.2 versus 6.5 months.
Atezolizumab is a monoclonal antibody designed to bind and block the interactions of the protein PD-L1, found on tumor cells and tumor-infiltrating immune cells, and reactivate T cells. In IMpower130, researchers excluded individuals with EGFR and ALK mutations, who are eligible for other molecularly targeted treatments. The researchers also evaluated patients' outcomes based on their PD-L1 expression status, though the study results demonstrated atezolizumab's efficacy in the entire intent to treat lung cancer population.
During the trial, grade 3 and 4 treatment-related adverse events were reported in 73.2 percent of patients who received the atezolizumab and chemotherapy combination treatment compared to 60.3 percent in patients who received only chemotherapy.