The phase III IMpassion130 study has met its co-primary endpoint of progression-free survival (PFS). Results demonstrated that the combination of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) as first-line treatment significantly reduced the risk of disease worsening or death in patients with metastatic or unresectable locally advanced triple-negative breast cancer. Overall survival (OS) is encouraging in the programmed cell death-ligand 1 (PD-L1)–positive population at this interim analysis, and follow up will continue until the next planned analysis.
Safety in the atezolizumab plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Results will be presented at an upcoming medical meeting, and will be submitted to global health authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
“IMpassion130 is the first positive phase III immunotherapy study in triple-negative breast cancer, an aggressive disease with limited treatment options,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Genentech. “Highly encouraged by these results, we plan to submit to authorities globally with the aim of bringing this combination to people with triple-negative breast cancer as soon as possible.”
More About the IMpassion130 Study
The IMpassion130 study is a phase III, multicenter, randomized, double-blind study evaluating the efficacy, safety, and pharmacokinetics of atezolizumab and nab-paclitaxel compared with placebo in combination with nab-paclitaxel in people with locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic breast cancer. The study enrolled 902 people who were randomized equally (1:1). The co-primary endpoints were PFS per investigator assessment (RECIST 1.1) and OS. PFS and OS were assessed in all randomized participants (intention-to-treat [ITT]) and in those whose disease expressed the PD-L1 protein. Secondary endpoints included objective response rate, duration of response, and time to deterioration in Global Health Status/Health-Related Quality of Life.
During the treatment duration, people in arm A received atezolizumab at a fixed dose of 840 mg via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle and nab-paclitaxel at a dose of 100 mg/m2 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. Participants received both agents until unacceptable toxicity or disease progression.
Arm B received nab-paclitaxel at a dose of 100 mg/m2 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. Participants received both agents until unacceptable toxicity or disease progression.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.