The FDA granted a priority review to a supplemental biologics license application (sBLA) for atezolizumab (Tecentriq) for the first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations and high PD-L1 expression (TC3/IC3 wild-type [WT]), according to Genentech, the manufacturer of the PD-L1 inhibiting immunotherapy agent.
The FDA must make its decision on the drug’s approval by June 19, 2020.
The sBLA is based on results from the randomized, open-label phase III IMpower110 study, where atezolizumab bested chemotherapy (cisplatin or carboplatin plus gemcitabine) in overall survival (OS) by 7.1 months (average OS, 20.2 months versus 13.1 months for atezolizumab and chemotherapy, respectively) in patients with high PD-L1 expression. Patients enrolled (n = 572) in the study had advanced non-squamous or squamous NSCLC without ALK or EGFR mutations and did not previously have chemotherapy treatment.
“In the IMpower110 study, Tecentriq alone demonstrated a significant improvement in overall survival compared with chemotherapy for people newly diagnosed with certain types of advanced non-small cell lung cancer,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, in a statement.
The primary endpoint of IMpower110 was OS by PD-L1 subgroups (TC3/IC3-WT; TC2/3/IC2/3-WT; and TC1,2,3/IC1,2,3-WT) as determined by the SP142 assay. Secondary endpoints included investigator-assessed progression-free survival, objective response rate, and duration of response.
No new safety signals were identified in the trial, with adverse events (AEs) aligning with what has previously been reported for treatment with atezolizumab. Grade 3-4 treatment-related AEs were reported in 12.9% of patients in the atezolizumab arm, compared with 44.1% in the chemotherapy arm.
“We are working closely with the FDA to bring this chemotherapy-free option to these patients as quickly as possible,” Garraway said.
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