Atezolizumab/Chemotherapy Approved by FDA in First-Line Treatment of Metastatic Lung Cancer
Posted: Thursday, December 5, 2019
On December 4, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with nab-paclitaxel (Abraxane) and carboplatin in the first-line treatment of adults with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
This approval is based on results from the phase III open-label, randomized IMpower130 study, which enrolled 724 patients with stage IV nonsquamous NSCLC. It showed that atezolizumab plus chemotherapy (nab-paclitaxel and carboplatin) resulted in significantly longer median overall survival than chemotherapy alone (18.6 vs. 13.9 months; hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.64–0.99; P = .0384) in the intention-to-treat wild-type population (n = 681). The atezolizumab combination therapy also significantly improved progression-free survival compared with chemotherapy alone (7.2 vs. 6.5 months; HR = 0.75; 95% CI = 0.63–0.91; P = .0024) in the intention-to-treat wild-type population.
Safety for the atezolizumab/chemotherapy combination was reported to be consistent with the known safety profiles of the individual agents, and no new safety signals were identified with the combination. Grade 3 or 4 treatment-related adverse events were reported in 73.2% of patients receiving atezolizumab plus chemotherapy compared with 60.3% of patients receiving chemotherapy alone.
Atezolizumab is approved in the United States in combination with bevacizumab and paclitaxel and carboplatin in the first-line treatment of adults with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations. Also, in the United States, atezolizumab plus carboplatin and etoposide is approved in the first-line treatment of adults with extensive-stage small cell lung cancer.