FDA Issues Alert About Concerns With Atezolizumab Plus Paclitaxel in Triple-Negative Breast Cancer
Posted: Friday, September 11, 2020
On September 8, the U.S. Food and Drug Administration (FDA) announced that a clinical trial studying the use of atezolizumab plus paclitaxel in previously treated patients with inoperable locally advanced or metastatic triple-negative breast cancer showed the combination therapy did not significantly reduce the risk of disease progression and death compared with placebo plus paclitaxel in the PD-L1–positive population. The FDA alert stated that atezolizumab in combination with paclitaxel is not approved for use in breast cancer.
The multicenter, double-blind, phase III IMpassion131 trial studied the use of atezolizumab and paclitaxel in previously untreated patients with inoperable locally advanced or metastatic triple-negative breast cancer. Patients were randomly assigned to the treatment combination or a placebo with paclitaxel.
Trial results found no significant risk reduction for cancer progression and death in patients treated with the combination therapy compared with patients in the PD-L1–positive population given placebo and paclitaxel. In addition, interim overall survival results favored paclitaxel and placebo over paclitaxel and atezolizumab in both the PD-L1–positive population and the total study population.
The FDA plans to review the findings from this clinical trial and communicate new information regarding the study results and any potential changes to prescribing information. Furthermore, the FDA also is evaluating the use of this combination therapy in ongoing clinical trials for breast cancer and will recommend additional changes as appropriate.
The FDA stated that health-care professionals should not replace protein-bound paclitaxel with paclitaxel in clinical practice. In addition, the FDA alert advises patients taking atezolizumab and paclitaxel for other approved uses to continue to take their medication as directed by their health-care professional.