On June 18, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the Phase III IMpassion031 study met its primary endpoint, regardless of PD-L1 status, as initial treatment for people with early triple-negative breast cancer (Press release, Chugai, JUN 18, 2020, View Source [SID1234561207]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

"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. Osamu Okuda, Chugai’s President and COO. "TNBC is an aggressive and rapidly progressing disease with limited treatment options, and there are high unmet medical needs. We will be working together with Roche to provide patients with this new treatment option as early as possible."

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 American Joint Committee on Cancer (AJCC) staging system in the ITT population and in the PD-L1-positive population.

About Triple-Negative Breast Cancer (TNBC)
In Japan, 92,200 women (2019 predicted value) are estimated to be afflicted with breast cancer each year. 15,100 women in Japan (2019 predicted value) die as a result of the disease.1) Triple-negative breast cancer accounts for 15% of all breast cancer cases and, is more common in women under the age of 50, compared with other forms of breast cancer.2-4) Triple-negative breast cancer is defined by the lack of expression of hormone receptors (estrogen and progesterone receptors) and the overexpression of human epidermal growth factor receptor 2 (HER2). In general, triple-negative breast cancer has a high tumor-proliferative capacity and shorter overall survival, compared with other forms of breast cancer.3, 5)

Trademarks used or mentioned in this release are protected by law.

Sources

Project Cancer Statistics, 2019. Cancer Information Service, National Cancer Center, Japan. [Internet; cited June, 2020] Available from: View Source
Yao H et al. Triple-negative breast cancer: is there a treatment on the horizon? Oncotarget. 2017;8(1):1913–1924.
BreastCancer.org. What is Triple-Negative Breast Cancer? [Internet; June, 2020] Available from: View Source
Cancer Treatment Centers of America. Triple negative breast cancer risk factors. [Internet; cited June, 2020]
View Source
Pal SK et al. Triple negative breast cancer: unmet medical needs. Breast Cancer Res Treat. 2011;125(3):627-636.