The FDA approved atezolizumab in combination with chemotherapy for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
The FDA approved atezolizumab (Tecentriq) in combination with chemotherapy for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations, according to Genentech, the agent’s manufacturer.
The agency’s approval was based on results from the multicenter, open-label, randomized phase III IMpower130 study, designed to evaluate the efficacy and safety of atezolizumab in combination with nab-paclitaxel (Abraxane) and carboplatin compared with chemotherapy alone for chemotherapy-naÃ¯ve patients with stage IV non-squamous NSCLC. In total, 724 patients were enrolled in the study, of whom 681 were in the intention-to-treat wild-type (ITT-WT) population that was randomized 2:1 to either combination therapy (arm A) or chemotherapy alone (arm B).
During the treatment-induction phase, arm A received atezolizumab and carboplatin on day 1 of each 21-day cycle, and nab-paclitaxel on days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit, whichever occurred first; while arm B received carboplatin on day 1 and nab-paclitaxel on days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression, whichever occurred first. Patients in arm B received best supportive care during the maintenance treatment phase, and switch maintenance to pemetrexed was permitted.
The co-primary end points of the study were progression-free survival (PFS) as determined by the investigator using RECIST v1.1 in people without EGFR or ALK mutations and overall survival (OS), both in the ITT-WT population of patients.
Median OS was 18.6 months in the atezolizumab arm, compared with 13.9 months in the chemotherapy arm (HR, 0.80; 95% CI, 0.64–0.99; P = .0384), while PFS was 7.2 months versus 6.5 months, respectively (HR, 0.75; 95% CI, 0.63–0.91; P = .0024).
The safety profile of the atezolizumab arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.
Grade 3/4 adverse events were reported in 73.2% of patients in the atezolizumab arm, compared with 60.3% of those receiving chemotherapy alone.
“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 non-squamous non-small cell lung cancer,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genetech, said in a press release. “(This) approval offers another opportunity to help prolong the lives of people with this type of the disease.”
FDA approves Genentech’s Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-small cell lung cancer. Genentech (Roche). Published December 3, 2019. https://bit.ly/33Hixpz. Accessed December 3, 2019.