FDA Approves Frontline Atezolizumab Plus Chemo for Metastatic Non-Squamous NSCLC

December 4, 2019

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-naïve 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.”

Reference:

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.