FDA expands Tecentriq approval for metastatic lung cancer
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The FDA expanded the approval of atezolizumab to include first-line monotherapy of patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression.
The approval applies to use of the atezolizumab (Tecentriq, Genentech) by patients who have no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
This is the fourth indication in metastatic NSCLC and fifth overall in lung cancer for atezolizumab, a monoclonal antibody designed to bind with PD-L1.
“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, said in a company-issued press release.
The FDA based the new indication on results of an interim analysis of the randomized phase 3 IMpower110 study, which enrolled 572 PD-L1-selected patients with chemotherapy-naive, stage IV nonsquamous or squamous NSCLC who had no EGFR or ALK genomic tumor aberrations.
The trial was designed to evaluate the efficacy and safety of atezolizumab monotherapy vs. chemotherapy.
Researchers randomly assigned patients 1:1 to atezolizumab monotherapy or chemotherapy, which consisted of cisplatin or carboplatin combined with either pemetrexed or gemcitabine, followed by maintenance therapy with pemetrexed alone or best supportive care.
OS by PD-L1 subgroup — determined by the Ventana PD-L1 (SP142) Assay — served as the primary efficacy endpoint. Key secondary endpoints included investigator-assessed PFS, objective response rate and duration of response.
Results showed longer median OS in the atezolizumab group (20.2 months vs. 13.1 months; HR = 0.59; 95% CI, 0.4-0.89) among patients with high PD-L1 expression.
Atezolizumab exhibited a safety profile consistent with prior use. No new safety signals emerged.
Grade 3 or grade 4 treatment-related adverse events occurred among 12.9% of patients assigned atezolizumab and 44.1% of those assigned chemotherapy.