FDA Grants Priority Review to Roche’s Tecentriq Monotherapy for First-Line Treatment of Advanced NSCLC

On February 19, Roche announced that the United StatesRocheThe U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for Tecentriq (atezolizumab) as a first-line (initial) monotherapy for patients with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) who have high PD-L1 expression (TC3/IC3 wild-type [WT]) and no EGFR or ALK mutations, as determined by PD-L1 biomarker testing. The FDA also granted Priority Review to this application, with a decision expected by June 19, 2020. Last week, Tecentriq (atezolizumab; brand name Tecentriq) was approved in China for use in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer.

This sBLA is based on the results of the Phase 3 clinical study IMpower110, which demonstrated that in patients with high PD-L1 expression (TC3/IC3-WT), Tecentriq monotherapy extended 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). The safety profile of Tecentriq was consistent with its known safety profile, and no new safety signals were identified. Grade 3–4 treatment-related adverse events (AEs) were reported in 12.9% of patients treated with Tecentriq and 44.1% of patients receiving chemotherapy.

“In the IMpower110 study, Tecentriq monotherapy demonstrated a significant improvement in overall survival compared with chemotherapy in patients with newly diagnosed, certain types of advanced non-small cell lung cancer,” said Dr. Levi Garraway, Global Head of Product Development and Chief Medical Officer at Roche. “We are working closely with the FDA to bring chemotherapy-free treatment options to this population of lung cancer patients as soon as possible.”

Currently, the lung cancer research program for Tecentriq includes nine Phase III studies in lung cancer, covering both monotherapy and combination therapies for the treatment of various types of lung cancer. In addition, Roche has established an extensive development plan for Tecentriq, including multiple ongoing and planned Phase III studies involving cancers of the lung, genitourinary system, skin, breast, gastrointestinal tract, gynecologic system, and head and neck.

References:

[1] FDA grants priority review to Roche’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer. Retrieved 2020-02-19, from https://www.roche.com/media/releases/med-cor-2020-02-19.htm

Original Title:Breaking News! FDA Grants Priority Review to Roche’s Application for Tecentriq Monotherapy as First-Line Treatment for Lung Cancer

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