Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): Updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial
The Lancet Oncology Dec 11, 2019
Schmid P, Rugo HS, Adams S, et al. - Researchers define the prespecified second interim overall survival analysis of the phase 3 IMpassion130 study evaluating atezolizumab plus nab-paclitaxel in terms of efficacy and safety in patients with unresectable, locally advanced or metastatic triple-negative breast cancer. The eligible patients included in this randomised, placebo-controlled, double-blind, phase 3 trial were administered atezolizumab 840 mg or matching placebo intravenously on day 1 and day 15 of every 28-day cycle and nab-paclitaxel 100 mg/m2 of body surface area intravenously on days 1, 8, and 15 until progression or unacceptable toxicity. This investigation was carried out in 246 academic centres and community oncology practices in 41 countries. In this second interim overall survival analysis of IMpassion130, overall survival between the treatment groups in the intention-to-treat population did not differ significantly—a finding consistent with the first interim analysis—but atezolizumab plus nab-paclitaxel provided a clinically meaningful overall survival benefit in patients with PD-L1 immune cell-positive disease. However, because of the prespecified statistical testing hierarchy, this positive result could not be formally examined. Atezolizumab plus nab-paclitaxel affords a crucial curative option for patients with PD-L1 immune cell-positive metastatic triple-negative breast cancer, which represents a disease with a high unmet requirement.
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