Tecentriq Approved with Chemotherapy for First-Line Treatment of Metastatic NSCLC without EGFR or ALK Mutations

December 2019, Vol 10, No 6 - FDA Approvals, News & Updates


On December 3, 2019, the FDA approved atezolizumab (Tecentriq; ­Genentech), in combination with pac­litaxel protein-bound (Abraxane) and carboplatin chemotherapy, for the first-line treatment of adults with metastatic nonsquamous non–small-cell lung cancer (NSCLC) that does not harbor EGFR or ALK genomic mutations.

This approval was based on results of the IMpower130 study, a multicenter, randomized, open-label clinical trial of patients with stage IV nonsquamous NSCLC who did not receive any chemotherapy for metastatic disease; the patients could have received a previous EGFR or ALK inhibitor, if appropriate. A total of 724 patients were randomized to atezolizu­mab, paclitaxel protein-bound, and carboplatin, followed by monotherapy with atezolizumab or to paclitaxel protein-bound and carboplatin, followed by maintenance therapy with pemetrexed.

In the primary analysis of 681 patients without EGFR or ALK mutations, the estimated median progression-free survival was 7.2 months (95% confidence interval [CI], 6.7-8.3) with atezolizumab versus 6.5 months (95% CI, 5.6-7.4) in the control arm (hazard ratio, 0.75; 95% CI, 0.63-0.91; P = .0024). The median overall survival was 18.6 months (95% CI, 15.7-21.1) versus 13.9 months (95% CI, 12.0-18.7), respectively (P = .0384).

The most common adverse events (≥20%) with atezolizumab plus chemotherapy in patients with nonsquamous NSCLC were fatigue/asthenia, nausea, alopecia, constipation, diarrhea, and decreased appetite.