IMpassion130: first positive Phase III immunotherapy study in triple breast cancer
The Phase III IMpassion130 study has demonstrated that Tecentriq® (atezolizumab) plus chemotherapy Abraxane® (Nab-paclitaxel) significantly reduces the risk of disease worsening or death in individuals with metastatic or locally advanced triple negative breast cancer (TNBC).
This is the first positive Phase III immunotherapy study to demonstrate a statistically significant progression-free survival (PFS) improvement in intention-to-treat (ITT) and PD-L1 positive first-line metastatic TNBC populations.
Overall survival (OS) results have been reported as encouraging in the PD-L1 positive population at this interim analysis and follow up will continue until the next planned analysis.
IMpassion130 study is a Phase III multi-center, randomized, double-blind study evaluating the efficacy, safety, and pharmacokinetics of TECENTRIQ and nab-paclitaxel compared with placebo in combination with nab-paclitaxel in individuals with locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer. The study enrolled 902 individuals 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 (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, individuals in:
– Arm A received TECENTRIQ 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, 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 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. Participants received both agents until unacceptable toxicity or disease progression.
Safety in the TECENTRIQ 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.
“IMpassion130 is the first positive Phase III immunotherapy study in triple negative breast cancer, an aggressive disease with limited treatment options,” explained Sandra Horning (Genentech, CA, USA). “Highly encouraged by these results, we plan to submit to authorities globally with the aim of bringing this combination to people with TNBC as soon as possible.”
Results will be presented at an upcoming medical meeting and will be submitted to global health authorities, including the FDA and EMA.
Source: www.gene.com/media/press-releases/14733/2018-07-01/phase-iii-impassion130-study-showed-gene
