• The first approved immune checkpoint inhibitor in Japan for the treatment of PD-L1-positive triple-negative breast cancer

TOKYO, September 20, 2019 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has obtained regulatory approval for its humanized anti-PD-L1 monoclonal antibody, Tecentriq^® [generic name: atezolizumab (genetical recombination)] from the Ministry of Health, Labour and Welfare (MHLW) for an additional indication of PD-L1-positive, hormone receptor-negative and HER2-negative inoperable or metastatic breast cancer. It has also obtained approval for an additional formulation of Tecentriq 840 mg. Tecentriq 840 mg was developed to provide an optimal formulation for breast cancer for which approved dosage is 840 mg once every 2 weeks.

VENTANA OptiView PD-L1 (SP142), a pathological testing kit marketed by Roche Diagnostics K.K., should be used to detect PD-L1 expression. An expanded use of VENTANA OptiView PD-L1 (SP142) as a companion diagnostic of Tecentriq was approved on August 20, 2019 to allow physicians to identify patients with PD-L1-positive breast cancer who could benefit from Tecentriq.

“We are very pleased that Tecentriq has been approved as the first immune checkpoint inhibitor for the treatment of PD-L1-positive triple-negative breast cancer (TNBC) in Japan,” said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. “This approval provides a novel cancer immunotherapy-based treatment for TNBC, a rapidly-progressing cancer with limited therapeutic options. We are committed to contribute to patients through the treatment.”

This approval is based on the results from the phase III IMpassion130 study. Tecentriq in combination with nab-paclitaxel (albumin-bound) met primary endpoint with a significant reduction in the risk of disease worsening or death (PFS) compared with nab-paclitaxel (albumin-bound) alone in the intention-to-treat (ITT) population (median PFS=7.2 vs 5.5 months; hazard ratio [HR]=0.80, 95%CI: 0.69-0.92, p=0.0025) and in people who were tested positive for PD-L1 expression (median PFS=7.5 vs 5 months; hazard ratio [HR]=0.62, 95% CI: 0.49-0.78, p<0.0001). Tecentriq and nab-paclitaxel (albumin-bound) showed a clinically meaningful improvement in the co-primary endpoint of overall survival (OS) in the PD-L1-positive population (median OS=25.0 vs 18.0 months; HR=0.71, 95% CI: 0.54-0.93) at the second interim analysis. OS results in the PD-L1-positive population were not formally tested due to the hierarchical design of the study as statistical significance was not met for OS in the intention-to-treat (ITT) population (median OS=21.0 vs 18.7 months; HR=0.86, 95% CI: 0.72-1.02, p=0.078). Follow-up will continue until the next planned analysis. The safety profile of Tecentriq in combination with chemotherapy was consistent with the known safety profiles of the individual medicines, and no new safety signals were identified.

About the IMpassion130 study
The IMpassion130 study is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel (albumin-bound) compared with nab-paclitaxel (albumin-bound) in people with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer. The co-primary endpoints are PFS per investigator assessment (RECIST 1.1) and OS in the ITT population and in the PD-L1-positive population.

<Reference>
Roche’s Tecentriq in combination with Abraxane improves outcomes as an initial treatment for people with PD-L1-positive metastatic triple-negative breast cancer (Press release issued by Roche on October 20, 2018)
https://www.roche.com/media/releases/med-cor-2018-10-20.htm

Chugai Files for Additional Indication and Additional Formulation of Anti-PD-L1 Antibody TECENTRIQ^® for Breast Cancer (Press release issued by Chugai on December 21, 2018)
https://www.chugai-pharm.co.jp/english/news/detail/20181221153000_582.html

Roche presents data from across its breast cancer portfolio at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Press release issued by Roche on June 3, 2019)
https://www.roche.com/media/releases/med-cor-2019-06-03.htm

Free Offering of Tecentriq 840 mg prior to the Listing in the NHI Reimbursement Price List
Under the system for healthcare services provided combining insurance-covered and non-covered services provided by MHLW, Chugai will offer Tecentriq for free to respond to requests for emergency use from patients with PD-L1-positive, hormone receptor-negative and HER2-negative inoperable or metastatic breast cancer with very limited treatment options. In the context of proper use, Tecentriq will be offered for free only to medical institutions participated in the clinical study of IMpassion130 study for development of the drug as clinical sites on condition that; 1) they would use the drug in accordance with the approved indications and dosage and administration and 2) they would corporate with us in implementing various safety measures to promote proper use, including activities based on Early Post-Marketing Phase Vigilance conducted by Chugai during the free offering period. The offering will start immediately after the date of regulatory approval and end on the day before the listing in the NHI reimbursement price list.

As a top pharmaceutical company in the field of oncology in Japan, Chugai is committed to contribute to patients and medical professionals by offering Tecentriq as a new treatment option and accordingly, to improve access of medications and their proper use.

Prescribing Information *The underlined parts were newly added.

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