A major breakthrough in first-line treatment of liver cancer! Roche's cancer immunization programme Tecentriq and Avastin (Tai Sanqi and Avetin) is about to be approved by the European Union!

!--, 22 September 2020 // -- Roche has announced that the European Medicines Agency (EMA) Commission on Human Pharmaceutical Products (CHMP) has issued a positive review recommending approval of anti-PD-L1 therapy Te Centriq (Tai Sanqi, generic name: atezolizumab, atilijutatin monoanti) in a joint Avastin (Avistin, generic name: bevacizumab, beva bevajuumab) is used to treat adult patients with non-excisive or metastatic hepatocellular carcinoma (HCC) who have not been systematically treated in the past.
, CHMP's comments will now be submitted to the European Commission, which usually makes a final review decision within two months.
U.S. regulatory aspects, tecentriq-Avastin was approved by the FDA in May to treat non-removable or metastasis HCC patients who have not previously received systematic treatment.
the adaptation was reviewed and approved under the ORbis initiative of the FDA's Real-Time Oncology Review (RTOR) pilot program.
recently, the Tecentriq-Avastin combination has been recommended by the European Society of Oncology (ESMO) as a Class I drug for the treatment of non-removable HCC, and has been adopted by many clinical practice guidelines worldwide.
, the program was accepted by the State Drug Administration (NMPA) in January and was granted priority review at the end of February.
it is worth mentioning that the Tecentriq-Avastin combination is the first and only cancer immunotherapy treatment approved for the treatment of non-removable or metastasis HCC.
from the IMbrave150 clinical trial, tecentriq-Avastin combined therapy significantly extended total lifetime (OS) and progression-free lifetime (PFS) compared to the standard care drug sorafenib.
is a major cause of death among the world, especially in Asia, and hepatocellular carcinoma (HCC) is the most common type of liver cancer.
HCC occurs mainly in patients with cirrhosis caused by chronic hepatitis (HCV) or alcohol consumption, usually at a late stage of diagnosis, with very limited treatment options.
IMbrave150 is the first Phase III cancer immunotherapy study to show improvements in OS and PFS in the most common liver cancer treatments.
combination of Tecentriq and Avastin is also the first treatment to improve total survival in patients with non-removable hepatocellular carcinoma who have not previously received systematic treatment for more than a decade.
Roch's Chief Medical Officer and Head of Global Product Development, Dr. Levi Garraway, M.D., said, "The positive comments recommended by CHMP represent an important step towards bringing Tecentriq-Avastin's combined treatment to patients with advanced or non-excisible hepatocellular carcinoma in Europe and represent an important milestone in the treatment of this deadly malignancies.
Professor Bruno Sangro, Director of Hepatology and Regional Coordinator of HPB Oncology at the Navala Clinical University in Pamplona, Spain, said: "After more than a decade of stagnation in treatment, the results of the IMbrave150 study are likely to change the way we treat patients diagnosed with or at an advanced stage of hepatocellular carcinoma.
The study data show that the combined use of Tecentriq-Avastin significantly prolongs patients' survival, improves quality of life, and, for most patients, induces deep, long-lasting and sometimes complete tumor relief compared to the tyrosine kinase inhibitors currently selected.
" IMbrave150 (NCT03434379) is an open-label, multicenter, randomized Phase III study conducted in patients with non-removable, partial late stage or metastasis HCC who had not previously received systematic treatment, investigating the efficacy and safety of Tecentriq's combined treatment with Avastin in relation to the standard care drug, the multi-kinase inhibitor sorafenib.
the study, patients were randomly assigned to Tecentriq-Avastin combined therapy (n=336) or Solaffinie (n=165) on a 2:1 scale until an unacceptable toxic reaction or loss of clinical benefit.
the study's common primary endpoint was the total lifetime (OS) and progress-free lifetime (PFS) determined by the independent assessment agency based on version 1.1 (RECIST 1.1) of the solid tumor efficacy evaluation criteria.
results showed a significant increase in the total survival of the Tecentriq-Avastin combined treatment group (medium OS: NE vs 13.2 months) and a 42% reduction in the risk of death (HR-0.2) compared to the Solafini group 58,95% CI: 0.42-0.79, p-0.0006), 12-month survival rate increased (67.2% vs 54.6%).
In addition, the disease-free survival of the Tecentriq-Avastin combined treatment group was significantly extended (medium PFS: 6.8 months vs. 4.3 months), and the risk of disease progression or death was reduced by 41% (HR-0.59, 95% CI: 0.47-0.76, p.0001).
the study, 38 percent of patients in the Tecentriq-Avastin combined treatment group experienced severe adverse reactions (grades 3-4), with the most common (-2%) being gastrointestinal bleeding, infection and fever.
results were published in the New England Journal of Medicine (NEJM), the world's top medical journal, in May.
!--/ewebeditor:page--!--ewebeditor:page title"--Tecentriq belongs to PD-(L)1 tumor immunotherapy, designed to bind to 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-1, Tecentriq can activate T-cells, which have the potential to be a basic combination therapy for cancer immunotherapy, targeted drugs, and chemotherapy for various cancers.
Avastin is an angiogenesic inhibitor that targets the binding of endovascular growth factors (VEGF).
VEGF plays an important role in angiogenesic and maintenance throughout the tumor life cycle.
Avastin infects the tumor's blood supply by binding directly to VEGF, preventing it from interacting with the subjects on the blood vessel cells.
blood supply to the tumor is considered to be key to the tumor's ability to grow and metastasis in the body.
strong scientific basis for combining Tecentriq with Avastin, a combination of Tecentriq and Avastin that has the potential to strengthen the immune system against tumors.
In addition to its established anti-angiogenesic effects, Avastin can further enhance Tecentriq's ability to restore the body's anti-cancer immunity by inhibiting VEGF-related immunosuppression, promoting T-cell tumor immersion, and initiating T-cell response to tumor antigens.
December 2018, the FDA approved Tecentriq-Avastin-Chemotherapy (Caprain and Yew alcohol) for first-line treatment of metastasis non-squamous non-small cell lung cancer (NSq NSCLC) adult patients without EGFR or ALC genomic tumor atromortization.
Group B patient data, which was approved based on the IMpower150 study, showed that tecentriq-Avastin-chemotherapy significantly extended the survival of patients (medium OS: 19.2 months vs 14.7 months, HR-0.78, p-0.016) compared to Avastin-chemotherapy.
() Original origin: Roche receives positive CHMP opinion for Tecentriq in the composition with Avastin for the treatment of people with the most common form of liver !--/ewebeditor: page--.