Atezolizumab Approved for the Treatment of Metastatic NSCLC That Has Progressed During or After Platinum-Containing Therapy
On October 18, 2016, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab.
Atezolizumab is a programmed cell death ligand 1 (PD-L1) blocking antibody that previously received FDA accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed after platinum-containing chemotherapy.
OAK and POPLAR Trials
This approval was based on two international, randomized, open-label clinical trials (OAK and POPLAR) that demonstrated consistent results in efficacy and safety in a total of 1,137 patients with NSCLC. Compared with docetaxel, treatment with atezolizumab in the intended patient population in the two trials resulted in a 4.2- and 2.9-month improvement in overall survival, respectively.
The median overall survival in OAK was 13.8 months (95% confidence interval [CI] = 11.8–15.7) in the atezolizumab arm compared to 9.6 months (95% CI = 8.6–11.2) in the docetaxel arm (hazard ratio [HR] = 0.74 [95% CI = 0.63–0.87]; P = .0004). The median overall survival in POPLAR was 12.6 months (95% CI = 9.7–16.0) and 9.7 months (95% CI = 8.6–12.0) in the atezolizumab and docetaxel arms, respectively (HR = 0.69; 95% CI = 0.52–0.92).
The most common (≥ 20%) adverse reactions in patients in the primary safety analysis population (POPLAR trial) in patients treated with atezolizumab were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation. The most common (≥ 2%) grade 3/4 adverse events in patients treated with atezolizumab were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, aspartate aminotransferase increase, alanine aminotransferase increase, dysphagia, and arthralgia. Clinically significant immune-related adverse events for patients receiving atezolizumab included pneumonitis, hepatitis, colitis, and thyroid disease.
The recommended atezolizumab dose is 1,200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.
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®.
