First-line treatment for liver cancer! Because of Roche, Mercado/Weiss "Immune-targeted" combination Keytruda-Lenvima was rejected by the FDA!

, July 09, 2020 //BioValleyBIOON/ -- Merck and Co and partner Eisai recently jointly announced that the U.SFood and Drug Administration (
FDA) has issued a full response letter (CRL) to each other's applications, which involves the anti-PD-1 Thetherapy Keytruda (Corrida, generic name: pembrolizumab, pabolizumab) and the oral multireceptor tyrosine kinase inhibitor Lenvima (levima, generic name: lenvatinib, lenvatinib) combined with the first line of treatment for patients with non-removable hepatoblastic cancer (HCC)applications are based on data from the single-arm open label Ib-524/Study 116 testThe data showed that in patients with non-removable HCC who had not previously been treated with a systematic treatment, Keytruda-Lenvima therapy showed clinical efficacy: 36% total remission rate (ORR) and 12.6 months of median remission duration (DOR)The data was presented at ASCO's annual meeting in May 2020 and supports the breakthrough drug qualification (BTD) granted by theFDAin July 2019however, before the effective date of the prescription drug user charges (PDUFA) applications from Mercado and Eaves, another combination therapy was approved on the basis of a randomized controlled trial that demonstrated the benefits of total survival (OS), according to the Search Biovalley article, it was determined that the other combination therapy referred to here refers to Roche's anti-PD-L1 therapy Tecentriq (tesanchi, generic name: atezolizumab, atzhuzumab) and Avastin (Avetin, generic name: bevacizumab, bevassa)The combination therapy was approved by the FDA at the end of May this year for first-line treatment of HCC patients, specifically in patients with non-removability or metastatic HCC who have not previously been treated with a systematic treatmentnoteworthy, the Tecentriq-Avastin portfolio is the first and only approved cancer immunotherapy program for the treatment of non-removable or metastatic HCCData from the Phase III IMbrave150 study showed that Tecentriq-Avastin combination therapy significantly extended total survival (median OS: 13.2 months) and non-progression survival (median PFS: 6.8 months vs 4.3 months), reduced the risk of death by 42%, and reduced the risk of disease progression or death by 411% compared to the standard care drug sorafeniba major breakthrough in the liver cancer decade! Tecentriq-Avastin (Tesanchi-Anvitin) first-line treatment significantly extends total survival! therefore, the FDA noted in crL that the application of Mercado and Thesis did not provide evidence that the keytruda-Lenvima combination of therapies showed a meaningful advantage over the non-resectionable or metastatic HCC therapy currently available without previous lying system therapy two companies plan to as applications based on the KEYNOTE-524/Study-116 study no longer meet accelerated approval criteria The FDA to work together to take appropriate next steps, including conducting a well-controlled clinical trial to demonstrate the efficacy and clinical benefits of combination drug use Currently, a Phase III trial for evaluation of the First Line Ofta-Lenvima combination therapy for advanced HCC treatment is under way and patient entry has been completed note that this CRL does not affect Keytruda and Lenvima's currentapproved indications Mercado and Aishi are continuing to evaluate 13 different types of tumor in the joint treatment of Keytruda and Lenvima in 18 clinical trials, including the LEAP (LEnvatinib And Pembrolizumab) clinical project KEYNOTE-524/Study 116 Test Design and Data: KEYNOTE-524/Study 116 (NCT03006926) is an open-label, one-arm Ib trial conducted in 100 patients with non-removable hepatocellular carcinoma (HCC) who have not previously been treated with a system to evaluate the efficacy and safety of the Keytruda Lenvima combination drug In the study, patients received an intravenous infusion of 200 mg of Keytruda every 3 weeks, while lenvima 8 mg or 12 mg was given daily (according to baseline weight: 60 kg, s.60 kg) The main endpoints are the Total Remission Rate (ORR) and Mitigation Duration (DOR) assessed by the Independent Imaging Examination (IIR) based on the Improved Solid Tumor Outcome Evaluation Criterion (mRECIST) and RECIST v1.1, and the secondary endpointincludes Progression Less Progress (PFS), Disease Progression Time (TTP), and Total Survival (OS) at the data cut-off (October 31, 2019) and median follow-up for 10.6 months (95% CI: 9.2-11.5), 37 patients were still in the study (Keytruda-Lenvima:n:34; Lenvima:n-3), and the median duration of keytruda-Lenvima combination therapy was 7.9 months (range: 0.21-1.11) The final analysis of the main endpoint of the showed that IIR determined that the ORR of Keytruda-Lenvima combination therapy was 36% (n-36; 95% CI:26.6-46.2), total mitigation rate (CR) was 1% (n-1), partial remission rate (PR) was 35% (n-35), and median ORD was 12.6 months (95%) IIR determined that the ORR for Keytruda-Lenvima combination therapy was 46% (n?46; 95% CI: 36.0-56.3), total mitigation rate (CR) was 11% (n-11), partial mitigation rate (PR) was 35% (n-35), median DOR was 8.6 months (95% CI-6- non-assessment) treatment-related adverse events (TRAE) caused 6% of patients to discontinue Keytruda-Lenvima, 10% to discontinue Keytruda, and 14% to discontinue Lenvima Keytruda is an anti-PD-1 tumor immunotherapy that helps detect and fight tumor cells by improving the body's immune system Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, activating T lymphocytes that may affect tumor cells and healthy cells Lenvima is a targeted drug found and developed within Theatech, an oral multireceptor tyrosine kinase (RTK) inhibitor with a novel binding pattern that inhibits other agiogenesis and carcinogenic signaling pathways associated with tumor angiogenesis, tumor progression, and tumor immunomodificationof the tumor(PDGF) receptor P In addition to DGFR alpha, KIT and RET), it is possible to selectively inhibit the kineactivity of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2, VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3, FGFR4) Keytruda-Lenvima combination therapy is part of a strategic collaboration between Mercadon and Theosoncology In March 2018, the two sides signed a $5.8 billion cooperation agreement to develop Lenvima monodrug and Keytruda for the treatment of multiple types of tumors In addition to the ongoing evaluation of Keytruda and Lenvima's combination of treatments for several different types of tumors, including renal cell carcinoma, the two sides have initiated new clinical studies through the LEAP clinical project and are evaluating 13 different types of tumors (endometrial cancer, hepatocellular carcinoma, melanoma, non-small cell lung cancer, kidney cell carcinoma, head and neck squamous cell cancer, uroral dermatoma, biliary cancer, triple-negative breast cancer, coloncancer, gastric cancer, and breast cancer (biovalleybioon.com) original source: Merck and Eisai ReceivEd Response Letter for keytruda ® (pembrolizumab) and lenvima ® (lenvatinib) Combination as First-Line Treatment for Unresectable Hepatcio