Chugai Launches Tecentriq Intravenous Infusion 840 mg as an Optimized Regimen for PD-L1-Positive Triple-Negative Breast Cancer in Japan

November 28, 2019 News /Bio ValleyBIOON/ -- Chugai Pharmaceutical, a Japanese pharmaceutical company controlled by Roche, recently announced the launch of PD-L1 in JapanTumorThe 840 mg intravenous formulation of the immunotherapy Tecentriq (atezolizumab). The 840 mg dosage strength of Tecentriq will provide an optimized regimen, administered once every two weeks, for the treatment of PD-L1-positive unresectable or recurrent triple-negative breast cancer.Breast Cancer(TNBC) patients.

This September, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved a new indication for Tecentriq: in combination with chemotherapy (Abraxane [albumin-bound paclitaxel], nab-paclitaxel) as an initial therapy for the treatment ofTumorAdult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (≥1%) and who have not previously received chemotherapy for metastatic disease (chemotherapy-naïve). In addition, the MHLW approved the 840 mg dosage strength of Tecentriq, which was developed to provide an optimized treatment regimen for breast cancer, at an approved dose of 840 mg once every two weeks.

Notably, Tecentriq is the first immune checkpoint inhibitor approved in Japan for the treatment of PD-L1-positive triple-negative breast cancer (TNBC). TNBC is a rapidly progressive form of breast cancer with very limited treatment options. Tecentriq provides the TNBC population in Japan with aTumorNew Treatment Regimens Based on Immunotherapy. The VENTANA OptiView PD-L1 (SP142) histopathology test kit, already marketed by Roche in Japan, will be used to detect PD-L1 expression. This kit was approved on August 20, 2019, as a companion diagnostic for Tecentriq.DiagnosisKit, allowing physicians to identify PD-L1-positive breast cancer patients who may benefit from Tecentriq treatment.

Triple-negative breast cancer (TNBC) is an aggressive and difficult-to-treat form of breast cancer, representing a significant unmet medical need. In the United States and the European Union, the Tecentriq plus Abraxane combination is the first cancer immunotherapy regimen approved by regulatory authorities for the treatment of PD-L1-positive metastatic TNBC. Currently, Roche is conducting multiple Phase III studies evaluating Tecentriq for the treatment of TNBC, including both early-stage and advanced-stage disease.

This approval is based on data from the Phase III IMpassion130 study, the first positive Phase III trial of cancer immunotherapy conducted in patients with triple-negative breast cancer (TNBC). This multicenter, randomized, double-blind study enrolled 902 patients with unresectable locally advanced or metastatic TNBC who had not previously received systemic therapy for metastatic breast cancer. It evaluated the efficacy and safety of Tecentriq in combination with Abraxane as first-line treatment, compared with placebo plus Abraxane. The co-primary endpoints were progression-free survival (PFS) and overall survival (OS). PFS and OS were assessed in all randomized patients (i.e., the intent-to-treat [ITT] population) and in PD-L1-positive patients. Secondary endpoints included objective response rate (ORR), duration of response (DOR), and time to deterioration in global health status/health-related quality of life (GHS/HRQoL).

The results showed that, compared with the placebo + Abraxane regimen, the Tecentriq + Abraxane regimen inTumorIn the patient population with positive PD-L1 expression in infiltrating immune cells (IC), the risk of disease progression or death was significantly reduced by 38% (median PFS: 7.5 months vs. 5.0 months; HR=0.62, 95% CI: 0.49–0.78; p<0.0001). Furthermore, in the PD-L1-positive population, the Tecentriq plus Abraxane regimen demonstrated a clinically meaningful improvement in overall survival (OS), extending OS by 7 months compared to the placebo plus Abraxane regimen (median OS: 25.0 months vs. 18.0 months; HR=0.71, 95% CI: 0.54–0.93). As the difference in OS did not reach statistical significance in the intent-to-treat (ITT) population (median OS: 21.0 months vs. 18.7 months; HR=0.86, 95% CI: 0.72–1.02; p=0.078), no formal testing of OS results was conducted for the PD-L1-positive population. In this study, the safety profile of the Tecentriq plus Abraxane combination was consistent with the known safety profiles of each individual drug, and no new safety signals were identified with the combination therapy.

The study will continue to follow up with patients until the next planned analysis. AssessmentTumorPD-L1 expression in infiltrating immune cells (ICs) is critical for identifying patients with triple-negative breast cancer (TNBC) who may benefit from the Tecentriq plus Abraxane combination. In this study, PD-L1 expression status was assessed usingDiagnosisVENTANA PD-L1 (SP142) Assay Kit.

Tecentriq is a PD-(L)1 cancer immunotherapy that targets and binds to tumor cells andTumorPD-L1 protein expressed on infiltrating immune cells, blocking its interaction with PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq can activate T cells.

To date, Tecentriq has been approved in multiple countries as a monotherapy and in combination with targeted therapies and/or chemotherapy for the treatment of various types of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), certain types of metastatic urothelial carcinoma (mUC), and PD-L1-positive triple-negative breast cancer (TNBC). In late August this year, Tecentriq received approval in Japan for use in combination with chemotherapy (carboplatin plus etoposide) as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC). This approval makes Tecentriq the first cancer immunotherapy in Japan for the treatment of aggressive and refractory ES-SCLC.

Breast cancer is the most common type of cancer in women, with over 2 million new cases diagnosed globally each year. Triple-negative breast cancer (TNBC) accounts for approximately 15% of all breast cancers and is more prevalent in women under the age of 50 compared to other subtypes. TNBC is specifically defined by the negative expression of estrogen receptors (ER), progesterone receptors (PR), and human epidermal growth factor receptor 2 (HER2). It progresses rapidly, carries a very poor prognosis, and has a 5-year survival rate of less than 15%. TNBC does not respond to hormonal therapy or HER2-targeted therapies (such as Herceptin), leaving treatment options very limited and primarily reliant on chemotherapy. Metastatic TNBC is among the most aggressive and difficult-to-treat forms of breast cancer. (Bioon.com)

Original Source: Chugai Launches Tecentriq Intravenous Infusion 840 mg as an Optimal Formulation for the Treatment of PD-L1-Positive Inoperable or Metastatic Triple-Negative Breast Cancer