FDA Approves New Firstline NSCLC Drug Combo

The U.S. Food and Drug Administration approved Tecentriq^® (atezolizumab) in combination with Abraxane^® (paclitaxel) and carboplatin for firstline treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) without EGFR or ALK genomic tumor aberrations.

The approval was based on results from the multicenter, open-label, randomized, phase III IMpower130 study that included 724 patients with stage IV chemotherapy-naïve non-squamous NSCLC.

Improved survival with the addition of atezolizumab

Patients were randomized to receive atezolizumab plus paclitaxel and carboplatin (chemotherapy) or chemotherapy alone. The addition of atezolizumab improved overall survival (OS; co-primary endpoint); median OS was 18.6 months in the atezolizumab group and 13.9 months in the chemotherapy-only group (hazard ratio [HR] = 0.80; 95% CI, 0.64-0.99; P=0.038) in the intention-to-treat wild-type population (n=681).

Median progression-free survival (co-primary endpoint) was also longer in the atezolizumab group (median, 7.2 months vs. 6.5 months; HR=0.75; 95% CI, 0.63-0.91; P=0.0024).

Grade 3/4 treatment-related adverse events occurred in 73.2% of patients who received atezolizumab plus chemotherapy versus 60.3% of patients who received chemotherapy alone. The researchers said there were no new safety concerns associated with the combination regimen.