FDA Approves Tecentriq for Adults With Extensive-Stage Small Cell Lung Cancer

Atezolizumab in Combination with Chemotherapy is the Only First-line Cancer Immunotherapy for ES-SCLC

The FDA has approved atezolizumab (Tecentriq, Genentech) in combination with carboplatin and etoposide for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

The approval was based on results from the IMpower133 study which demonstrated that atezolizumab combined with chemotherapy significantly extended the lives of patients with ES-SCLC compared to chemotherapy alone. In addition, the combination treatment significantly lowered the risk of disease worsening or death compared to chemotherapy alone.

ES-SCLC is a highly aggressive, difficult-to-treat form of lung cancer with few treatment advances over the last two decades. According to the American Cancer Society, approximately 70% of people with SCLC are diagnosed with ES-SCLC.

Atezolizumab is also approved in combination with bevacizumab, paclitaxel, and carboplatin for the initial treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. In addition, Atezolizumab is approved for adults with metastatic NSCLC with disease progression during or after platinum-containing chemotherapy.

IMpower133, a phase 3, multicenter, double-blinded, randomized placebo-controlled study, evaluated the efficacy and safety of atezolizumab in combination with chemotherapy (carboplatin and etoposide) versus chemotherapy (carboplatin and etoposide) alone in chemotherapy-naïve adults with ES-SCLC.

The most common adverse reactions in people receiving atezolizumab plus chemotherapy were fatigue/asthenia, nausea, alopecia, decreased appetite, constipation, and vomiting.

Atezolizumab is also approved to treat urothelial carcinoma and triple-negative breast cancer.

Source: Genentech, March 18, 2019