IMpassion031 study is evaluating Tecentriq in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy. The study met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) for the treatment of people with early triple-negative breast cancer (TNBC), regardless of PD-L1 expression. The IMpassion031 study is the second positive phase III study demonstrating the benefit of Tecentriq in TNBC, and the first Tecentriq study to demonstrate benefit in early TNBC.
Safety for the Tecentriq combination appeared consistent with the known safety profiles of the individual medicines and no new safety signals were identified. Results of the IMpassion031 study will be presented at an upcoming medical meeting and will be discussed with global health authorities including the
'Tecentriq is the first approved immune checkpoint inhibitor in the breast cancer field. We are pleased that Tecentriq showed positive results in the treatment of the early TNBC,' said Dr.
About the IMpassion031 study
The IMpassion031 study is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy, in people with previously untreated, early TNBC. The study enrolled 333 people who were randomized in a 1:1 ratio to receive Tecentriq or placebo plus chemotherapy in the neoadjuvant (before surgery) setting. The primary endpoint is pCR using the
About Triple-Negative Breast Cancer (TNBC)
In
Contact:
Tel: +81-3-3273-0881
Email: pr@chugai-pharm.co.jp
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