FDA Accepts sBLA for Atezolizumab Plus Chemotherapy in First-Line Treatment of Metastatic NSCLC
Posted: Tuesday, February 5, 2019
Recently, the U.S. Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) for monoclonal antibody atezolizumab in combination with nanoparticle albumin–bound paclitaxel and carboplatin in the first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer (NSCLC) who do not have an EGFR or ALK genomic tumor aberration. The FDA is expected to make a decision on approval by September 2, 2019.
This sBLA is based on results from the phase III IMpower130 study (ClinicalTrials.gov identifier NCT02367781), which met its co-primary endpoints of overall and progression-free survival in the initial treatment of metastatic nonsquamous NSCLC.
IMpower130’s interim analysis showed that patients treated with atezolizumab plus chemotherapy had a median overall survival of 18.6 months, compared with 13.9 months in patients treated with chemotherapy alone in the intention-to-treat wild-type population. Those treated with the atezolizumab-based combination also had a median progression-free survival of 7.0 months, compared with 5.5 months for those treated with chemotherapy alone in the intention-to-treat wild-type population.
Safety for the atezolizumab plus chemotherapy combination appeared to be consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination therapy. Grade 3 or 4 treatment-related adverse events were reported in 73.2% of patients receiving atezolizumab plus chemotherapy compared with 60.3% of those receiving chemotherapy alone.