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.
“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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