FDA approves first-line Tecentriq plus chemotherapy for metastatic nonsquamous non-small cell lung cancer
The FDA approved atezolizumab plus nab-paclitaxel and carboplatin for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer, according to a manufacturer-issued press release.
This approval of atezolizumab (Tecentriq, Roche/Genentech), an anti-PD-L1 monoclonal antibody, plus nab-paclitaxel (Abraxane, Celgene) and carboplatin applies to patients without EGFR or ALK mutations.
“We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with nonsquamous non-small cell lung cancer,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said in a press release. “Today’s approval offers another opportunity to help prolong the lives of people with this type of the disease.”
The FDA based this approval, in part, on data from the phase 3 IMpower130 study, which included 724 chemotherapy-naive patients with stage IV nonsquamous NSCLC. Researchers randomly assigned 681 of these patients — all of whom were wild-type for EGFR and ALK mutations — 2:1 to treatment with atezolizumab plus nab-paclitaxel and carboplatin, or chemotherapy alone.
PFS — determined by the investigators using RECIST v1.1 criteria — and OS among patients without EGFR or ALK mutations served as coprimary endpoints.
Results showed the addition of atezolizumab to chemotherapy significantly extended survival in the intention-to-treat population without EGFR and ALK mutations (median OS, 18.6 months vs. 13.9 months; HR = 0.8; 95% CI, 0.64-0.99). The combination also was associated with longer median PFS (7.2 months vs. 6.5 months; HR = 0.75; 95% CI, 0.63-0.91).
Researchers observed no new safety signals with the combination. In total, 73.2% of patients assigned atezolizumab plus chemotherapy and 60.3% assigned chemotherapy alone experienced grade 3 to grade 4 treatment-related adverse events.