On December 21, 2018 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application for humanized anti-PD-L1 monoclonal antibody TECENTRIQ [generic name: atezolizumab (genetical recombination)] to the Ministry of Health, Labour and Welfare (MHLW) for an additional indication of unresectable, locally advanced or metastatic breast cancer and a new 840 mg formulation (Press release, Chugai, DEC 21, 2018, View Source [SID1234532239]).
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This application is based on the results from a global phase III clinical study (IMpassion130 study). The IMpassion130 study is a multicenter, double-blind, randomized, placebo-controlled, global clinical study evaluating the efficacy, safety, and pharmacokinetics of TECENTRIQ in combination with nab-paclitaxel (albumin-bound) compared with nab-paclitaxel alone (albumin-bound) in patients with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic breast cancer. Co-primary endpoints of this study are progression-free survival per investigator assessment and overall survival. Both primary endpoints are assessed in intent-to-treat (ITT) and PD-L1 positive population. Secondary endpoints are objective response rate, duration of response, and time to deterioration in Global Health Status/Health-Related Quality of Life.
"Triple-negative breast cancer is an aggressive disease with poor prognosis and high unmet medical needs," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. "TECENTRIQ is the first immune checkpoint inhibitor whose efficacy against triple-negative breast cancer has been confirmed. We are committed to deliver atezolizumab to patients as early as possible, and contribute to the realization of better treatment in Japan."
[Reference information]
Roche’s Tecentriq in combination with Abraxane improves outcomes as an initial treatment for people with PD-L1-positive metastatic triple-negative breast cancer (Roche media release dated October 20, 2018)
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About Triple-Negative Breast Cancer
In Japan, 86,500 women (2018 predicted value) are estimated to be afflicted with breast cancer each year. 14,285 women in Japan (2017 predicted value) die as a result of the disease. 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. 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.
About TECENTRIQ
In Japan, TECENTRIQ was approved for "unresectable and advanced/recurrent non-small cell lung cancer" in January, 2018 and launched in April. Applications for additional indications of first-line treatment of small cell lung cancer were filed, and first-line treatment of non-small cell lung cancer were approved in December, 2018.
References
Cancer Registry and Statistics. Cancer Information Service, National Cancer Center Japan from: View Source Accessed October 2018
Abramson VG et al. Subtyping of triple-negative breast cancer: implications for therapy. Cancer. 2015;121(1):8-16. 3.
Cancer Center. Triple negative breast cancer risk factors. [Internet; cited 2018 May 24]. Available from: View Source Accessed October 2018.
Pal SK et al. Triple negative breast cancer: unmet medical needs. Breast Cancer Res Treat. 2011;125(3):627-636.
American Cancer Society. Breast Cancer Facts & Figures 2013-2014
Lehmann BD et al. Identification of human triple-negative breast cancer subtypes and preclinical models for selection of targeted therapies. J Clin Invest. 2011;121(7):2750-67.