FDA Grants Priority Review to Tecentriq Combination for Triple Negative Breast Cancer

The Food and Drug Administration granted a priority review to Tecentriq (atezolizumab) plus Abraxane (nab-paclitaxel) for the frontline treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in patients 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 Tecentriq plus Abraxane compared with placebo plus Abraxane 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) 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 Tecentriq 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 Tecentriq 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 percent of patients in the Tecentriq arm compared with 18 percent 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, M.D., 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 12 March 2019.