FDA Accepts sBLA for Tecentriq, Abraxane Combo for First-Line NSCLC Therapy

Officials with the FDA have accepted Genentech’s supplemental Biologics License Application (sBLA) for atezolizumab (Tecentriq) in combination with chemotherapy as first-line treatment for certain patients with non-small cell lung cancer (NSCLC), according to a press release.

If approved, atezolizumab will be available in combination with nab-paclitaxel (Abraxane) and carboplatin for patients with metastatic non-squamous disease who do not have EGFR or ALK genomic tumor aberrations. According to Genentech, the FDA is expected to make a decision on the application by September 2, 2019.

The sBLA is based on data from the phase 3 IMpower130 study evaluating the efficacy and safety of atezolizumab in combination with carboplatin and nab-paclitaxel versus chemotherapy alone in this patient population. The trial included 724 chemotherapy-naïve patients with stage 4 non-squamous NSCLC randomized into 2 treatment arms: atezolizumab plus nab-paclitaxel and carboplatin compared with nab-paclitaxel and carboplatin.

According to the results, the study met its overall survival (OS) and progression-free survival (PFS) co-primary endpoints in the intention-to-treat wild-type population. The analysis showed that atezolizumab plus chemotherapy significantly extended survival compared with chemotherapy alone (median OS=18.6 versus 13.9 months; hazard ratio [HR] = 0.79; 95% CI: 0.64—0.98; p=0.033). Additionally, the atezolizumab-based combination also significantly reduced the risk of disease worsening or death compared with the chemotherapy treatment arm (median PFS=7.0 versus 5.5 months; HR=0.64; 95% CI: 0.54–0.77; p<0.0001), according to the data.

Regarding treatment-related adverse events (AEs), 73.2% of patients receiving atezolizumab plus chemotherapy experienced grade 3-4 AEs compared with 60.3% of patients receiving chemotherapy alone.

“We look forward to working with the FDA in order to bring this Tecentriq-based combination to people with non-squamous non-small cell lung cancer as soon as possible,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in a press release. “Lung cancer is a challenging disease to treat, and this review takes us one step closer towards offering a new treatment option that has shown a clinically meaningful survival benefit in the treatment of this type of disease.”

Atezolizumab was recently approved by the FDA for use in this patient population in combination with Avastin, paclitaxel, and carboplatin. It is also indicated for use in patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy.

Reference

FDA Accepts Genentech’s Supplemental Biologics License Application for Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer [news release]. Genentech’s website. https://www.gene.com/media/press-releases/14773/2019-01-16/fda-accepts-genentechs-supplemental-biol. Accessed January 16, 2019.