Three negative breast cancer first immunization program! Roche launched tecentriq 840mg intravenous preparation in Japan to provide optimized treatment plan!

November 28, 2019 / BIOON / -- Chugai Pharma, a Japanese pharmaceutical company controlled by Roche, recently announced the launch of 840mg intravenous preparation of PD-L1 tumor immunotherapy tecentriq (atezolizumab) in Japan Tecentriq 840mg dose specification will provide an optimized regimen, once every two weeks, for the treatment of PD-L1 positive non resectable or recurrent triple negative breast cancer (TNBC) patients In September, Japan's Ministry of health, labor and welfare (MHLW) approved a new indication for tecentriq: combination chemotherapy (Abraxane [albumin binding paclitaxel], nab paclitaxel) as an initial treatment for cancer Adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who express PD-L1 (≥ 1%) and have not previously received chemotherapy (initial chemotherapy) to control metastatic disease In addition, MHLW has also approved the dose specification of tecentriq 840mg, which will provide an optimized breast cancer treatment plan with the approved dose of 840mg once every two weeks It is worth mentioning that tecentriq is the first immunocheckpoint inhibitor approved in Japan for the treatment of PD-L1 positive TNBC TNBC is a rapidly developing breast cancer, and its treatment options are very limited Tecentriq provides a new treatment based on tumor immunotherapy for TNBC population in Japan Ventana OptiView PD-L1 (sp142), a pathological detection kit that Roche has launched in Japan, will be used to detect the expression of PD-L1 The kit was approved on August 20, 2019 as a companion diagnostic kit for tecentriq, allowing doctors to identify PD-L1 positive breast cancer patients who can benefit from tecentriq treatment TNBC is an invasive and difficult type of breast cancer, which has a high degree of unmet medical needs In the United States and the European Union, the tecentriq + Abraxane combination is the first cancer immunotherapy program approved by regulatory authorities for the treatment of PD-L1 positive metastatic TNBC At present, Roche is carrying out a number of phase III studies to evaluate tecentriq's treatment of TNBC, including the early and late stages of the disease This approval, based on data from phase III study impassion130, is the first positive phase III cancer immunotherapy study in TNBC patients This is a multicenter, randomized, double-blind study in which 902 patients with non resectable locally advanced or metastatic TNBC who had not previously received systemic therapy for metastatic breast cancer were enrolled The efficacy and safety of the combination of tecentriq and Abraxane in the first-line treatment were evaluated and compared with placebo and Abraxane The common end points were progression free survival (PFS) and overall survival (OS) PFS and OS were evaluated in all randomized patients (i.e., intention to treat [ITT]) and PD-L1 positive patients, with secondary endpoints including objective response rate (ORR), duration of response (DOR), and deterioration time of overall health status / health-related quality of life (GHS / HRQOL) The results showed that compared with placebo plus Abraxane, tecentriq plus Abraxane significantly reduced the risk of disease progression or death by 38% (median PFS: 7.5 months vs 5.0 months, HR = 0.62, 95% CI: 0.49-0.78, P < 0.0001) In addition, in the PD-L1 positive population, the tecentriq + Abraxane regimen showed an improvement in clinical significance (median OS: 25.0 months vs 18.0 months, HR = 0.71, 95% CI: 0.54-0.93), compared with the placebo + Abraxane regimen Because the OS in ITT group did not reach statistical significant difference (median OS: 21.0 months vs 18.7 months, HR = 0.86, 95% CI: 0.72-1.02, P = 0.078), the OS results of PD-L1 positive group were not formally tested In this study, the safety of tecentriq + Abraxane combination was consistent with the known safety of each drug, and no new safety signal was found in the combination The study will continue to follow up patients until the next scheduled analysis Evaluation of PD-L1 expression in tumor infiltrating immune cells (IC) is essential to identify TNBC patients who can benefit from the tecentriq + Abraxane combination In this study, the expression of PD-L1 was detected by the diagnostic kit Ventana PD-L1 (sp142) Tecentriq belongs to PD - (L) 1 tumor immunotherapy It targets to bind PD-L1 protein expressed on tumor cells and tumor infiltrating immune cells, and blocks its interaction with PD-1 and B7.1 receptors Tecentriq can activate T cells by inhibiting PD-L1 Up to now, tecentriq has been approved by many countries as a single drug therapy and combined targeted therapy and / or chemotherapy to treat various types of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), some types of metastatic urothelial cancer (MUC), PD-L1 positive triple negative breast cancer (TNBC) At the end of August this year, tecentriq was approved by Japan to treat adult patients with extensive small cell lung cancer (es-sclc) with combination chemotherapy (carboplatin + etoposide) This approval makes tecentriq the first cancer immunotherapy for aggressive and refractory es SCLC in Japan Breast cancer is the most common type of cancer in women, with more than 2 million confirmed cases every year in the world TNBC accounts for about 15% of the total Compared with other types, TNBC is more common in women under 50 years old TNBC, especially estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (HER-2), is a kind of breast cancer with negative expression TNBC has no effect on hormone therapy and HER2 targeted therapy (such as Herceptin) The choice of treatment is very limited, which mainly depends on chemotherapy Metastatic TNBC is one of the most aggressive and refractory breast cancer Source of original text: Chugai launches tecentriq indoor infection 840 mg as an optimal formula for the treatment of pd-l1-positive inoperable or metastatic triple negative breath cancer