5th lung cancer indication! FDA approves Roche Tecentriq,single-drug first-line treatment PD-L1 high expression NSCLC!

May 19, 2020 /
PRNewswire
BIOON/--Roche's Gene Tekannounc recently announced that the U.SFood and Drug Administration (FDA) has approved the anti-PD-L1 therapy Tecentriq (Special Oddity, generic name: atezolizumab, Atzumab), as a first-line (initial) monotherapy for the treatment of metastatic non-small cell lung cancer (NCLSC) adult patients, specificallyA test approved by the FDAdetermined that tumors have a high expression of PD-L1 high expression (PD-L1 staining of 50% of tumor cells ( TC - 50%) or PD-L1 stained tumor l
eaching of the tumor sit is worth noting that this is Tecentriq's fourth approved u.Sregulatory response to metastatic NSCLC and the 5th for lung cancerThis approval will provide a first-line treatment option for specific patients without chemotherapyData from the Phase III IMpower110 study showed that tecentriq had significant survival benefits and significantly longer total lifetime (OS) than chemotherapy when treating patients with PD-L1 high expression on the first lineTecentriq is the first and only single-preparation cancer immunotherapy with three drug regimens, allowing administration every 2, 3 or 4 weeksThe Tecentriq single-drug first-line treatment of complementary biological productlicensation licensing (sBLA) wasthe FDAof priority review eligibilityThe drugs that are granted this qualification have the potential to provide significant improvements in the treatment, prevention ordiagnosis of diseases "We are pleased to offer patients with certain types of lung cancer a new choice that does not require chemotherapy, which can help extend their life span and can be administered under a flexible dosing program, including a monthly Tecentrin infusion," said Dr Levi Garraway, Chief Medical Officer and Global Head of Product Development, Roche Today's approval marks Tecentriq's fifth approval for lung cancer We remain committed to providing an effective and tailored treatment for every person diagnosed with this disease "
this approval, based on the results of the Phase III IMpower110 study This is a randomized, open label Phase III study, conducted in patients with advanced non-squamous or squamous non-small cell lung cancer (NSCLC) who were not previously subjected to chemotherapy (initial treatment) without ALK or EGFR mutation (wild type, WT) in patients with procedural death ligand 1 (PD-L1) biomarkers
, and were compared with the efficacy of primary chemotherapy as a single drug therapy study group of 572 patients (555 WT), these patients were randomly assigned at 1:1 ratio to receive: (1) Tecentriq monotherapy, until the loss of clinical benefits (based on the study investigators assessment) ;(2) cisplatin or ca Platinum (as determined by the investigator) combines pemere (non-scale) or Gisitambin (scale), and then uses pemelat (non-scale) or best support therapy (scale) alone until the disease progresses, unacceptable toxicity, or death The main therapeutic end point was the total lifetime (OS) of pD-L1 subgroup (TC3/IC3-WT; TC2/3/IC2/3-WT; TC1, 2, 3/IC1, 2, 3-WT), as determined by SP142 detection Key secondary endpoints include no progression lifetime (PFS), objective mitigation rate (ORR), and mitigation duration (DOR) assessed by the study investigators results show that the study reached its main endpoint in the mid-stage 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 month (median OS: 20.2 months vs13.1 months, HR s.595,95%CI: 0.398-0.890, p.0106) In the study, Tecentriq's security was consistent with the known security profile, and no new security signals were found In the Tecentriq treatment group, 12.9% of patients had a level 3-4 treatment-related adverse event (AE) and 44.1% in the chemotherapy group the above data show that in patients with high expression of Scaly or non-scale NSCLC with High Expression of PD-L1, tecentriq alone has significant survival benefits as a first-line (initial) treatment, providing additional treatment options for patients lung cancer is the leading cause of cancer death worldwide The disease kills 1.76 million people a 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, characterized by flat cells covering the surface of the airway when viewed under a microscope Tecentriq is a PD-(L)1 tumor immunotherapy that targets a protein called PD-L1 expressed on the of the tumor cells and tumor, blocking its interaction with PD-1 and B7.1 receptors By inhibiting PD-L1, Tecentriq activates T-cells, which have the potential to be the basis for cancer immunotherapy, targeted drugs and various cancer chemotherapy regimens to date, Tecentriq has been approved as a single-drug therapy, as well as joint targeted therapy and/or chemotherapy to treat multiple types of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), certain types of metastatic urinary tract cancer (mUC), PD-L1-positive triple-negative breast cancer (TNBC) In China, Tecentriq was approved in February 2020 for combination chemotherapy (Caplatinum plus epophilis), a first-line treatment of a wide range of patients with small cell lung cancer (ES-SCLC) It is worth mentioning that Tecentriq is the second PD-L1 drug approved in China on December 10, 2019, following the approval of the AstraZeneca anti-PD-L1 therapy Imfinzi (Infyfan, generic name: durvalumab, Duvalliu monoantigen) Together with 6 PD-1 drugs, the number of PD-1/L1 drugs currently on the market reached eight , Tecentriq's first-line application for the treatment of non-reprecable hepatocellular carcinoma (HCC) is under review by a number of regulators, including the United States, China and Japan HCC is the most common type of liver cancer The application is based on the results of the Phase III IMbrave150 study, which showed a statistically significant and clinically significant improvement in total survival (OS) and non-progressive survival (PFS) compared to the current standard nursing drug, sorafenib (Sorafenib) Roche has developed an extensive development plan for Tecentriq, including a number of ongoing and planned Phase III studies covering multiple types of lung cancer, genitourinary system cancer, skin cancer, breast cancer, gastrointestinal cancer, gynaecological and head and neck cancers This includes studies of Tecentriq alone or in combination with other drugs (BioValleyBioon.com) original source: FDA app
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