Atezolizumab (Tecentriq, Roche) plus chemotherapy nab-paclitaxel (Abraxane) met its co-primary endpoint of progression-free survival in patients with metastatic triple-negative breast cancer.
Atezolizumab (Tecentriq) plus chemotherapy nab-paclitaxel (Abraxane) significantly reduced the risk of disease worsening or death in patients with metastatic triple-negative breast cancer, according to a Roche press release.
According to results from the phase 3 IMpassion130 study, the combination therapy met its co-primary endpoint of progression-free survival (PFS).
Atezolizumab is a monoclonal antibody designed to bind with the PD-L1 protein, blocking its interactions with both PD-1 and B7.1 receptors. The drug is already FDA-approved for the patients with previously treated metastatic non-small cell lung cancer and for certain types of metastatic urothelial carcinoma.
In the trial, PFS was met in the intention-to-treat and PD-L1 positive population with metastatic or unresectable locally advanced triple-negative breast cancer, an aggressive disease for which there are limited treatment options. Additionally, overall survival (OS) results at interim analysis in the PD-L1 population were encouraging.
The IMpassion130 trial is a phase 3 study evaluating the efficacy, safety, and pharmacokinetics of atezolizumab plus nab-paclitaxel in patients with locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic breast cancer. The study included 903 patients who were randomized equally into 2 treatment arms.
In 1 treatment arm, patients received atezolizumab at a fixed dose of 840 milligrams via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle and nab-paclitaxel at a dose of 100 milligrams per square meter via IV infusion on days 1, 18, and 15 of each 28-day cycle. Nab-paclitaxel was administered for a target of at least 6 cycles, with no maximum. Patients received both agents until unacceptable toxicity or disease progression.
In the second arm, patients received nab-paclitaxel at a dose of 100 milligrams per square meter via IV infusion on days 1, 8, and 15 of each 28-day cycle. Nab-paclitaxel was administered for a target of at least 6 cycles, with no maximum and placebo was administered via IV infusion on days 1 and 15 of each 28-day cycle.
According to the press release, Roche expects to submit the results to health authorities globally, including the FDA and European Medicines Agency. Roche currently has 7 ongoing phase 3 studies investigating atezolizumab in triple-negative breast cancer.
Phase III IMpassion130 study showed Roche’s Tecentriq plus Abraxane significantly reduced the risk of disease worsening or death in people with metastatic triple negative breast cancer [news release]. Roche’s website. https://www.roche.com/media/releases/med-cor-2018-07-02.htm?utm_source=T&utm_medium=E. Accessed July 2, 2018.