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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
26 May 2020
Cancer Immunology and Immunotherapy;  Lung and other thoracic tumours

On 18 May 2020, the US Food and Drug Administration (FDA) approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of tumour cells [TC ≥ 50%] or PD-L1 stained tumour-infiltrating immune cells [IC] covering ≥ 10% of the tumour area [IC ≥ 10%]), with no EGFR or ALK genomic tumour aberrations.

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

Efficacy was evaluated in IMpower110 (NCT02409342), a multicentre, international, randomised, open-label trial in patients with stage IV NSCLC whose tumours express PD-L1 (TC ≥ 1% or IC ≥ 1%), who had received no prior chemotherapy for metastatic disease. Patients were randomised (1:1) to receive atezolizumab 1200 mg every 3 weeks until disease progression or unacceptable toxicity or platinum-based chemotherapy. The main efficacy outcome measure was overall survival (OS).

The trial demonstrated a statistically significant improvement in OS for patients with high PD-L1 tumour expression receiving atezolizumab compared to those treated with platinum-based chemotherapy. Median OS was 20.2 months (95% confidence interval [CI] 16.5, NE) for patients in the atezolizumab arm compared with 13.1 months (95% CI 7.4, 16.5) in the chemotherapy arm (hazard ratio [HR] 0.59; 95% CI 0.40, 0.89; p = 0.0106). There was no statistically significant difference in OS for the other two PD-L1 subgroups (TC ≥5% or IC ≥5%; and TC ≥1% or IC ≥1%) at the interim or final analyses.

Median progression-free survival (PFS) per investigator was 8.1 months (95% CI 6.8, 11.0) in the atezolizumab arm and 5.0 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 (ORR) per investigator was 38% (95% CI 29, 48) and 29% (95% CI 20, 39), respectively.

The most common adverse reaction (≥ 20%) with atezolizumab as a single agent in IMpower110 was fatigue/asthenia.

The recommended atezolizumab dose for treatment of NSCLC is 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks, administered intravenously over 60 minutes.

Full prescribing information for TECENTRIQ is available here.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was approved one month prior to the FDA goal date.

This application was granted priority review.

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.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate. 

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