FDA Grants Priority Review to Atezolizumab Combination for Metastatic TNBC Subset
The Food and Drug Administration (FDA) granted a priority review to atezolizumab (Tecentriq) in combination with nab-paclitaxel (Abraxane) for frontline use in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose disease expresses the PD-L1 protein.
The Food and Drug Administration (FDA) granted a priority review to atezolizumab (Tecentriq) in combination with nab-paclitaxel (Abraxane) for frontline use in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose disease expresses the PD-L1 protein, as determined by PD-L1 biomarker testing, according to Roche, the drug’s manufacturer.
The supplemental biologics license application was based on interim analysis data from the multicenter, randomized, double-blind phase 3 IMpassion130 study—designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab plus nab-paclitaxel compared with placebo plus nab-paclitaxel in 902 patients with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer.
Study results were presented at European Society for Medical Oncology (ESMO) 2018 Congress and published in the New England Journal of Medicine last month.
Progression-free survival, or time to disease worsening or death, and overall survival served as the co-primary endpoints, while secondary endpoints included objective response rate, duration of response and time to deterioration in Global Health Status/Health-Related Quality of Life.
The atezolizumab regimen significantly improved progression-free survival compared with the placebo arm (7.2 vs. 5.5 months), which was also seen among the PD-L1 subgroup (7.5 vs. 5 months).
The statistical significance was not met for overall survival in the intent-to-treat population; however, the atezolizumab combination demonstrated a clinically meaningful overall survival improvement in the PD-L1-positive population compared with the placebo arm (25 vs. 15.5 months).
Serious side effects were reported in 23% of patients in the atezolizumab arm compared with 18% in the placebo group.
Follow-up will continue until the next planned analysis.
“Tecentriq in combination with nab-paclitaxel has the potential to meaningfully advance treatment for people with PD-L1-positive, metastatic triple-negative breast cancer. People need more options for this type of breast cancer, which is particularly difficult to treat,” Sandra Horning, MD, Roche’s chief medical officer and head of global product development, said in a press release.
“We are working closely with the FDA to bring this Tecentriq combination to people with PD-L1-positive metastatic triple-negative breast cancer as soon as possible,” she added.
The FDA is expected to make a decision on the combination’s approval by March 12, 2019.