Approval was based on results from the phase 3 Impower130 study, which showed atezolizumab in combination with chemotherapy increased overall survival in participants compared with chemotherapy alone.
The FDA has approved atezolizumab (Tecentriq, Genetech) in combination with paclitaxel protein bound (Abraxane), a form of chemotherapy, as a first-line treatment for adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
This approval is based on results from the phase 3 Impower130 study, which showed atezolizumab in combination with chemotherapy helped people live significantly longer compared with chemotherapy alone.
The Impower130 study was a randomized, multicenter, open-label trial designed to evaluate the safety and efficacy of atezolizumab in combination with carboplatin plus nanoparticle albumin-bound (nab) paclitaxel in patients with NSCLC compared with chemotherapy alone. Researchers included 723 participants who were randomized to receive intravenous (IV) infusion atezolizumab and carboplatin and nab-paciltaxel or an IV infusion of carboplatin and nab-paclitaxel.
The study findings showed a significant and clinically meaningful improvement in overall survival and a significant improvement in progression-free survival with atezolizumab plus chemotherapy versus chemotherapy as a first-line treatment.
Safety for the atezolizumab plus chemotherapy combination was consistent with the known safety profiles of each individual medicine and no new safety signals were identified with the combination. Grade 3-4 treatment-related adverse events were reported in 73.2% of participants who received atezolizumab plus chemotherapy compared with 60.3% of participants who received chemotherapy alone.
The FDA has also approved atezolizumab for the initial treatment of adults with metastatic non-squamous NSCLC who have disease progression during or following platinum-containing chemotherapy in addition to an approved combination of bevacizumab, paclitaxel, and carboplatin for the first-line treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
There are currently 9 phase 3 studies underway for atezolizumbab alone and in combination with other medicines across different types of lung cancer, as well as multiple ongoing and planned phase 3 studies across genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.