The Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq (atezolizumab; Genentech) in combination with Abraxane (paclitaxel [bound to albumin (human), nab-paclitaxel]; Celgene) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express programmed death-ligand 1 (PD-L1), as determined by an FDA-approved test.

The approval, which is contingent upon verification and description of clinical benefit in confirmatory trials, was based on data from the phase 3 IMpassion130 study. Patients (N=902) with unresectable locally advanced or metastatic TNBC who had not received prior systemic therapy for metastatic breast cancer were randomized to receive Tecentriq + nab-paclitaxel or placebo + nab-paclitaxel. The co-primary endpoints were progression-free survival (PFS) and overall survival.

Results showed that the combination therapy was associated with a 40% reduced risk of disease worsening or death compared with nab-paclitaxel monotherapy (median PFS: 7.4 months vs 4.8 months; hazard ratio 0.60, 95% CI, 0.48–0.77; P<.0001); overall survival results were immature in the intent-to-treat population. No new safety signals were noted in the trial and safety profiles were similar to those seen with the individual drugs.

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“Chemotherapy alone has been the mainstay of treatment for many years, so it’s encouraging to now have an immunotherapy combination available for people with PD-L1-positive disease,” said Hayley Dinerman, executive director of the Triple Negative Breast Cancer Foundation.

Tecentriq, a PD-L1 blocking antibody, is already indicated for the treatment of locally advanced or metastatic urothelial carcinoma as well as metastatic non-small cell lung cancer.

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This article originally appeared on MPR