Roche anti-PD-L1 therapy Tecentriq Japan was approved

Chugai Pharma, a Japanese drugmaker controlled by Roche, recently announced that Japan's Ministry of Health, Labour and Labour (MHLW) has approved Tecentriq, an anti-PD-L1 therapy . , atili-pearl monotherapy) as a first-line (initial) monotherapy for patients who have not received chemotherapy (chemotherapy-naive, chemotherapy start-up), PD-L1-positive, non-excisive late stage, or recurring non-small cell lung cancer (NSCLC).
To date, Tecentriq has been approved for five different treatments in Japan: (1) as a single-drug therapy for patients who previously received chemotherapy;
approval will provide a first-line treatment option that does not require chemotherapy for specific NSCLC patients.
data from phase III IMpower110 study show that Tecentriq has significant survival benefits compared to chemotherapy in patients with high expression of PD-L1 in first-line treatment, significantly extending total lifetime (OS) by 7.1 months (mid-OS) : 20.2 months vs 13.1 months, HR=0.595,95%CI:0.398-0.890, p=0.0106).
VENTANA OptiView PD-L1 (SP142) is a pathological test kit sold by Roche Diagnostics K.K. that is used to detect the expression of PD-L1.
December 15, 2020, VENTANA OptiView PD-L1 (SP142) was approved to expand its use as an auxiliary diagnostic method for Tecentriq to enable clinicians to identify PD-L1-positive NSCLC patients who may benefit from Tecentriq treatment. Dr. Osamu Okuda, President and Chief Operating Officer of
Chinese and Foreign Pharmaceuticals, said, "We are very pleased with this additional approval for Tecentriq monotherapy, which has been shown to significantly extend total survival in patients with PD-L1-positive NSCLC who have not previously underwent chemotherapy.
in the NSCLC, Tecentriq has been approved for five different treatments.
we are committed to contributing to patients through these different therapies.
" this batch is based on the results of Phase 3 IMpower110 study.
This is a randomized, open-label Phase III study, selected in a programmed death ligation 1 (PD-L1) biomarker, previously unchemed (chemotherapy started), without APK or EGFR mutations (In patients with advanced non-squamous or squamous non-small cell lung cancer (NSCLC) in wild type, WT was conducted to assess the efficacy and safety of Tecentriq as a monotherapy treatment for first-line (initial) treatment and to compare it with chemotherapy.
study included 572 patients (555 WTs) who were randomly assigned to receive: (1) Tecentriq single-drug therapy until they lost clinical benefit (according to the study's investigators) ;(2 Cisplatin or carpton (at the investigator's decision) is combined with Pythaum (non-scale) or gissythabhambin (squamous), and then single-use pyrethroid (non-scaly) or best supportive therapy (scale) until the disease progresses, is unacceptablely toxic or dies.
the main therapeutic endpoints are the total lifetime (OS) of the PD-L1 subgroup (TC3/IC3-WT; TC2/3/IC2/3-WT; TC1, 2, 3/IC1, 2, 3-WT), which is determined by SP142 detection.
key secondary endpoints include progress-free lifetime (PFS), objective mitigation rate (ORR), and mitigation duration (DOR) assessed by the study investigator.
results show that the study reached its main endpoint in the medium-term analysis: in patients with PD-L1 high expression (TC3/IC3-WT), Tecentriq single-drug first-line therapy significantly increased total survival (OS) by 7.1 months compared to chemotherapy. (Middle OS: 20.2 months vs 13.1 months, HR:0.595,95%CI:0.398-0.890, p=0.0106).
, Tecentriq's security was consistent with the known security profile, and no new security signals were found.
12.9% of patients in the Tecentriq treatment group had level 3-4 treatment-related adverse events (AEs) and 44.1% in the chemotherapy group.
the above data show that in patients with highly expressed scaly or non-scaly NSCLC PD-L1, the use of Tecentriq alone as a first-line (initial) treatment has significant survival benefits compared to chemotherapy and can provide additional treatment options for patients.
is the leading cause of cancer death worldwide.
1.76 million people die from the disease each year;
lung cancer can be broadly divided into two broad categories: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
NSCLC is the most common type, accounting for about 85% of all cases.
NSCLC includes non-squamous cell lung cancer and squamous cell lung cancer, which is characterized by flat cells covering the surface of the gas channel when observed under a microscope.
Tecentriq is a PD-(L)1 tumor immunotherapy that targets a protein called PD-L1 expressed on tumor cells and tumor-immersed immune cells, blocking its interaction with PD-1 and B7.1 receptors.
by inhibiting PD-L1, Tecentriq can activate T-cells, which have the potential to serve as a basis for cancer immunotherapy, targeted drugs, and various cancer chemotherapy programs.
To date, Tecentriq has been approved in the United States, the European Union, and other countries around the world as a single-drug therapy, as well as a combination of targeted therapies and/or chemotherapy, to treat multiple types of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), certain types of metastatic urethroid skin cancer (mUC), PD-L1 positive triple negative breast cancer (TNBC).
Roche has developed an extensive development program for Tecentriq, including a number of ongoing and planned Phase III studies on multiple types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers.
this includes studies of Tecentriq taking drugs alone or treating them in a joint treatment with other drugs.
original origin: Chugai Obtains approval for Tecentriq as a Monotherapy for Naïve PD-L1-Positive Unreectable Advanced or Recurrent Non-Small Cell Cancer (NSCLC)