Tecentriq Receives 2 New Indications for Different Types of Cancer
Tecentriq plus Abraxane for Advanced or Metastatic Triple-Negative Breast Cancer with PD-L1 Expression
On March 1, 2019, the FDA accelerated the approval of atezolizumab (Tecentriq; Genentech) plus nab-paclitaxel (Abraxane; Celgene) for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and PD-L1 expression, as identified by an FDA-approved test. Tecentriq was previously approved for bladder cancer and for non–small-cell lung cancer. This is the first FDA approval of an immunotherapy for patients with metastatic TNBC.
The FDA approval of this new indication was based on the results of a clinical trial of 902 treatment-naïve patients with metastatic TNBC who were randomized to the immunochemotherapy combination with atezolizumab plus nab-paclitaxel or to placebo plus nab-paclitaxel. The median progression-free survival (PFS) was 7.2 months in the immunochemotherapy arm versus 5.5 months in the chemotherapy-alone arm; among patients with tumors expressing PD-L1, the median PFS was 7.5 months and 5.0 months, respectively.
The most common (≥20%) adverse events in this study were alopecia, peripheral neuropathies, fatigue, nausea, diarrhea, anemia, constipation, cough, headache, neutropenia, vomiting, and decreased appetite.
Tecentriq plus Chemotherapy for First-Line Treatment of Extensive-Stage Small-Cell Lung Cancer
On March 18, 2019, atezolizumab (Tecentriq; Genentech) received a new indication for use with carboplatin and etoposide chemotherapy as first-line treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC).
The FDA approved this new indication based on the results of a clinical trial of 403 patients who had not received previous chemotherapy for ES-SCLC. Patients were randomized to atezolizumab plus chemotherapy or to chemotherapy plus placebo. The median overall survival was 12.3 months in the atezolizumab arm compared with 10.3 months in the placebo arm. The median PFS was 5.2 months in patients receiving atezolizumab plus chemotherapy versus 4.3 months in those receiving chemotherapy plus placebo.
The most common (≥20%) adverse events associated with atezolizumab treatment included fatigue/asthenia, nausea, alopecia, constipation, and decreased appetite.