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FDA Approves Atezolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC


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On December 4, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with chemotherapy (nab-paclitaxel and carboplatin) for the first-line treatment of adults with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. Atezolizumab is a monoclonal antibody designed to bind with the programmed cell death ligand 1 (PD-L1) protein.

Pivotal Phase III Study

Approval of the combination is based on results from the phase III IMpower130 study, which showed atezolizumab in combination with chemotherapy improved median overall survival compared to chemotherapy alone (18.6 vs 13.9 months; hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.64–0.99; P = .04) in the intention-to-treat wild-type population. The atezolizumab-based combination also significantly reduced the risk of disease worsening or death compared with chemotherapy alone (median progression-free survival = 7.2 vs 6.5 months; HR = 0.75; 95% CI = 0.63–0.91; P = .002) in the intention-to-treat wild-type population.

Grade 3 or 4 treatment-related adverse events were reported in 73.2% of people receiving atezolizumab plus chemotherapy compared with 60.3% of those receiving chemotherapy alone.

About the IMpower130 Study 

IMpower130 was a phase III, multicenter, open-label, randomized study evaluating the efficacy and safety of atezolizumab in combination with nab-paclitaxel and carboplatin vs chemotherapy (nab-paclitaxel and carboplatin) alone for chemotherapy-naive patients with stage IV nonsquamous NSCLC. The study enrolled 724 people, of whom 681 were in the intention-to-treat wild-type population and were randomly assigned 2:1 to receive atezolizumab plus nab-paclitaxel and carboplatin (arm A), or nab-paclitaxel and carboplatin (arm B, control arm)

During the treatment-induction phase, people in 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. People in arm A received atezolizumab during the maintenance treatment phase until loss of clinical benefit was observed.

During the treatment-induction phase, people in 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. People in arm B received best supportive care during the maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. People were given the option to crossover to receive atezolizumab as monotherapy until further disease progression.

The co-primary endpoints were progression-free survival as determined by the investigator using Response Evaluation Criteria, version 1.1, in people without EGFR or ALK mutations (the intention-to-treat wild-type population) and overall survival in the intention-to-treat wild-type population.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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