On May 18, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq®) for first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 staining ≥ 50% of tumor cells [TC] or PD-L1-stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area), with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations. 

FDA Approves Atezolizumab for First-Line Treatment of Metastatic NSCLC With High PD-L1 Expression

FDA also approved the VENTANA PD-L1 (SP142) Assay as a companion diagnostic device for selecting patients with NSCLC for treatment with atezolizumab. 

Efficacy was evaluated in a multicenter, international, randomized, open-label trial (IMpower110; NCT02409342) of 572 patients with stage IV NSCLC whose tumors expressed TC ≥ 1% or IC ≥ 1% and who had received no prior chemotherapy for metastatic disease. Patients were randomized 1:1 to receive either platinum-based chemotherapy or atezolizumab 1,200 mg every three weeks until disease progression or unacceptable toxicity. The main efficacy outcome measure was overall survival (OS). 

The trial demonstrated a statistically significant improvement in OS for patients receiving atezolizumab compared to those treated with platinum-based chemotherapy. Median OS was 20.2 months (95% CI = 16.5, not evaluated) for patients in the atezolizumab arm compared to 13.1 months (95% CI = 7.4, 16.5) for those in the chemotherapy arm (HR = 0.59; 95% CI = 0.40, 0.89; p = 0.0106). The other two PD-L1 subgroups (TC ≥ 5% or IC ≥ 5% and TC ≥ 1% or IC ≥ 1%) had no statistically significant difference in OS at the interim or final analyses. 

Median progression-free survival per investigator was 8.1 months (95% CI = 6.8, 11.0) in the atezolizumab arm and five months (95% CI = 4.2, 5.7) in the platinum-based chemotherapy arm (HR = 0.63; 95% CI = 0.45, 0.88). Confirmed overall response rate per investigator was 38% (95% CI = 29, 48) and 29% (95% CI = 20, 39), respectively. 

The most common adverse reaction (≥ 20%) was fatigue/asthenia. 

The recommended atezolizumab dose for treatment of NSCLC is 840 mg every two weeks, 1,200 mg every three weeks, or 1,680 mg every four weeks, administered via IV over 60 minutes. 

View full prescribing information for atezolizumab

The review used the Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment. FDA approved the application one month prior to its goal date and granted the application priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 800-FDA-1088.  

For assistance with single-patient oncology investigational new drug applications, contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.