Roche recently announced the FDA accepted their supplemental biologics license application and granted priority review to atezolizumab for the treatment of non-small cell lung cancer.
The FDA recently accepted a supplemental biologics license application (sBLA) and granted priority review to atezolizumab (Tecentriq) as a first-line monotherapy to treat advanced non-squamous and squamous non-small cell lung cancer (NSCLC), according to a Roche news release.
The treatment is indicated for NSCLC without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.
The FDA set a PDUFA action date of June 19, 2020.
“In the IMpower110 study, Tecentriq alone demonstrated a significant improvement in overall survival compared with chemotherapy for people newly diagnosed with certain types of advanced non-small cell lung cancer,” said chief medical officer and head of global product development, Levi Garraway, MD, PhD, in a news release. “We are working closely with the FDA to bring this chemotherapy-free option to these patients as quickly as possible.”
The FDA approval is based on the results from the phase III, randomized, open-label IMpower 110 study, which evaluated the efficacy and safety of atezolizumab compared to chemotherapy in PD-L1-selected, chemotherapy-naÃ¯ve participants with advanced non-squamous or squamous NSCLC without ALK or EGFR mutations.
The results showed atezolizumab monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS, 20.2 vs 13.1 months; hazard ratio [HR], 0.595; 95% CI, 0.398–0.890; P= 0.0106) in the study population of 572 people. Grade 3-4 adverse events were present in 12.9% of patients receiving atezolizumab compared to 44.1% in patients receiving chemotherapy.
The primary endpoint for the IMpower 110 study was OS, with secondary endpoints including progression-free survival, objective response rate, and duration of response.
Atezolizumab is a monoclonal antibody that binds with PD-L1 proteins that are expressed on tumor cells to block interactions between those cells and both PD-1 and B7.1 receptors. The company has multiple ongoing and planned studies involving atezolizumab across a number of different cancers, according to Roche.
About 1.76 million people die of lung cancer annually, which makes it the leading cause of death across the globe. NSCLC and small cell lung cancer are the two major forms of lung cancer, with NSCLC accounting for about 85% of all cases, according to the American Cancer Society.
FDA grants priority review to Roche’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer [news release]. Basel. Published February 19, 2020. https://www.roche.com/media/releases/med-cor-2020-02-19.htm. Accessed February 19, 2020.