FDA Approves Atezolizumab as First-Line Monotherapy for Metastatic Non-Small Lung Cancer
The approval is based on an interim analysis from the phase 3 IMpower110 study, which showed atezolizumab monotherapy improved overall survival by 7.1 months compared with chemotherapy in people with high PD-L1 expression, according to a press release.
The FDA has approved atezolizumab (Tecentriq, Genentech) as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high programmed death-ligand 1 (PD-L1) expression or PD-L1 stained tumor-infiltrating covering ≥ 10% of the tumor area, as determined by an FDA-approved test with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.
The approval is based on an interim analysis from the phase 3 IMpower110 study, which showed atezolizumab monotherapy improved overall survival by 7.1 months compared with chemotherapy in people with high PD-L1 expression, according to a press release. The study included 572 people, of whom 554 were in the intention-to-treat wild-type population.
The safety profile appeared to be consistent for atezolizumab, and no new safety signals were identified. Grade 3-4 treatment-related adverse events were reported in 12.9% of people receiving atezolizumab compared with 44.1% of people receiving chemotherapy.
Atezolizumab is the first and only single-agent cancer immunotherapy with 3 dosing options, allowing administration every 2, 3, or 4 weeks, according to the press release. Additionally, atezolizumab has received 4 approvals across NSCLC, including as a single agent or in combination with targeted therapies and/or chemotherapies.
It is also approved in combination with carboplatin and etoposide for the first-line treatment of adults with extensive-stage small cell lung cancer.
“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,” said Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development, in a press release. “Today marks the fifth approval of Tecentriq in lung cancer, as we remain committed to providing an effective and tailored treatment option for every person diagnosed with this disease.”
FDA approves Genentech’s tecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer [news release]. South San Francisco, CA; Genentech: May 18, 2020. https://www.gene.com/media/press-releases/14850/2020-05-18/fda-approves-genentechs-tecentriq-as-a-f. Accessed May 19, 2020.