The Food and Drug Administration (FDA) has issued an alert regarding a clinical trial studying the use of atezolizumab (Tecentriq; Genentech Inc.) and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC).

The Impassion131 trial is evaluating atezolizumab in combination with paclitaxel compared with placebo and paclitaxel for patients with mTNBC. In this clinical trial, treatment with atezolizumab and paclitaxel did not significantly reduce the risk of cancer progression and death compared with placebo and paclitaxel in the PD-L1-positive population. Additionally, interim overall survival results favored paclitaxel plus placebo over paclitaxel plus atezolizumab in both the PD-L1-positive population and total population.

Atezolizumab in combination with paclitaxel is not approved for use in breast cancer. However, atezolizumab in combination with paclitaxel protein-bound (Abraxane)—a different combination therapy—is currently approved for the treatment of adult patients with mTNBC whose tumors express PD-L1, as determined by an FDA-approved test. Health care professionals should not replace paclitaxel protein-bound (Abraxane) with paclitaxel in clinical practice.

Patients taking atezolizumab and paclitaxel for other approved uses should continue to take their medication as directed by their health care professional.

Food and Drug Administration (FDA). FDA alerts health care professionals and oncology clinical investigators about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer [news release]. September 8, 2020. Available at: click here. Accessed September 10, 2020.