5th lung cancer adaptation! FDA approves Roche Tecentriq

.S. Food and Drug Administration (FDA) has approved the anti-PD-L1 therapy Tecentriq (Tersanqi, generic name: atezolizumab, atezolizumab, Atezumab) as a first-line (initial) single-drug therapy for the treatment of metastasis non-small cell lung cancer (NSCLC) adult patients, specifically: an FDA-approved test to determine that P-TD -L1 high expression (PD-L1 staining≥ 50% of tumor cells (TC≥50%) or PD-L1 stained tumor immersion (IC) covers ≥10% of tumor area (IC≥10%), advanced non-scale and scaly non-small cell lung cancer (NSCLC) adult patients without EGFR or ALC mutations.It's worth noting that this is Tecentriq's fourth adaptation for metastasis NSCLC and the fifth for lung cancer. This approval will provide a first-line treatment option that does not require chemotherapy for specific patients. Data from the Phase III IMpower110 study showed that Tecentriq had significant survival benefits and significantly longer total lifetime (OS) than chemotherapy in patients with high expression of PD-L1 in first-line treatment.Tecentriq is the first and only single-agent cancer immunotherapy with 3 dosing options, allowing dosage every 2, 3 or 4 weeks. The Tecentriq Supplemental Biologics Licensing Application (sBLA) for single-drug first-line treatment was eligible for FDA priority review. The drugs awarded this qualification have the potential to provide significant improvements in the treatment, prevention or diagnosis of diseases.Dr Levi Garraway, Roche's chief medical officer and head of global product development, said: "We are pleased to offer patients with certain types of lung cancer a new option that does not require chemotherapy, which helps to extend their life and can be given under a flexible dosing scheme, including a monthly Tecentriq infusion. Today's approval marks Tecentriq's fifth approval for lung cancer. We remain committed to providing an effective and tailored treatment for every patient diagnosed with the disease. Thethis approval, based on the results of Phase III IMpower110 study. This is a randomized, open-label Phase III study conducted in patients with advanced non-scaly or squamous non-small cell lung cancer (NSCLC) selected from programmed death ligation 1 (PD-L1) biomarkers who have not previously received chemotherapy (chemotherapy initial treatment), without ALC or EGFR mutations (wild type, WT), to assess the efficacy and safety of Tecentriq as a single-drug therapy for first-line (initial) therapy and to compare with chemotherapy.A total of 572 patients (555 WTs) in the study group were randomly assigned to receive: (1) Tecentriq single-drug treatment until clinical benefits were lost (according to the study's investigators) ;(2) Platinum or carptin (at the investigator's decision) is combined with Python (non-scaly) or gissytha (squamous), and then python (non-scale) or optimal supportive therapy (scale) alone 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.The results showed that the study had 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 lifetime (OS) by 7.1 months compared to chemotherapy (OS) Mid OS: 20.2 months vs 13.1 months, HR=0.595,95%CI:0.398-0.890, p=0.0106). In the study, Tecentriq's security was consistent with the known security profile, and no new safety signals were found. In the Tecentriq treatment group, 12.9% of patients had level 3-4 treatment-related adverse events (AE) and 44.1% in the chemotherapy group.The above data show that in patients with PD-L1 high expression of scaly or non-scaly NSCLC, the use of Tecentriq alone as a first-line (initial) treatment has significant survival benefits compared to chemotherapy, providing additional treatment options for patients.Lung cancer is the leading cause of cancer death worldwide. The disease kills 1.76 million people every 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 air 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).In China, Tecentriq was approved in February 2020 for combined chemotherapy (carbaptin plus etoposide), a first-line treatment for patients with extensive stage small cell lung cancer (ES-SCLC). It is worth mentioning that Tecentriq is the second PD-L1 drug approved in China following the approval by the National Drug Administration on December 10, 2019 of AstraZeneta's anti-PD-L1 therapy Imfinzi (Infinfan, generic name: durvalumab, duvalyu monoanti). In addition to 6 PD-1 drugs, the current domestic market of PD-1/L1 drugs reached 8.Currently, Tecentriq's supplementary application for first-line treatment of non-extinable hepatocellular carcinoma (HCC) is being reviewed by several 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 that the Tecentriq-Avastin programme resulted in statistically significant and clinically significant improvements in total lifetime (OS) and progress-free lifetime (PFS) compared to the current standard care drug sorafenib.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 untreated with other drugs. (Bio Valley Bioon .com)