"Immune-targeted" treatment! Mersadon/Guardian Keytruda and Lenvima combination treatment of hepatocellular carcinoma, renal cell carcinoma shows strong efficacy!

May 29, 2020 /
Biovalley
BIOON/ -- Merck and Co and partner Eisai recently jointly released new data on twoclinical trial(KEYNOTE-524/116, KEYNOTE-146/Study 111)The two trials evaluated the combination of Mercadon anti-PD-1 therapy Keytruda (pembrolizumab, Pablolizumab) and The Naturomer oral multireceptor tyrosine kinase inhibitor Lenvima (lenvatinib), and data showed that non-reformer hepatocellular carcinoma (HCC) had not previously been systematically treatedIn patients (KEYNOTE-524/Study 116 trial), metastatic transparent cell renal cell carcinoma (CCRCC) patients who sit on immunocheckpoint inhibitor therapy (KEYNOTE-146/Study 111), Keytruda and Lenvima combined therapy showed a clinically significant objective remission rate (ORR)Dr Jonathan Cheng, Vice President of Cancer Clinical Research,Mercadon Research Laboratory, said: "In these studies, keytruda-Lenvima demonstrated tumor remission rates that highlighted the potential of this combination in certain types of hepatocellular and renal cell carcinomasThe Keytruda-Lenvima portfolio is an important pillar of our extensiveoncology
research program, and we are continuing to advance joint therapeutic research across multiple cancer and disease phasesDr Takashi Owa, Chief Medical Creation officer and chief discovery officer of the's AiseshiOncologyBusiness Group, said: "As data from our joint trial continues to emerge, our enthusiasm and belief in the potential of the Keytruda-Lenvima portfolio has been reinforced by the growing evidence observed in multiple advanced cancers Our ongoing clinical research on this portfolio shows that we are committed to following science and exploring possible solutions for patients affected by suffering from cancer "
KEYNOTE-524/Study 116 Trial Design and Data: KEYNOTE-524/Study 116 (NCT03006926) is an open label, single-arm Ib trial conducted in 100 patients with non-reprecentable hepatocellular carcinoma (HCC) who had not previously received systematic treatment to evaluate the efficacy and safety of Keytruda-Lacrossa combined drug use In the study, patients received an intravenous dose of 200 mg of Keytruda every 3 weeks, while taking Lenvima 8 mg or 12 mg or 12 mg daily (based on baseline weight: 60 kg, s 60 kg) The primary endpoints are independent imaging examination (IIR) based on improved solid tumor efficacy evaluation criteria (mRECIST) and RECIST v1.1 assessment of total mitigation rate (ORR) and mitigation duration (DOR), and secondary endpoints include no progression (PFS), disease progression time (TTP), total lifetime (OS) at the data cut-off (October 31, 2019) and the median follow-up of 10.6 months (95% CI: 9.2-11.5), the median duration of the combination of 37 patients in the study (Keytruda and Lenvima: n?34; Lenvima:n?3), keytruda-Lenvima combined treatment was 7.9 months (range: 0.21.31.31) The final analysis of the main endpoints of the was determined by IIR that the ORR of the Keytruda-Lenvima combination therapy was 36% (n-36; 95% CI: 26.6-46.2), the full remission rate (CR) was 1% (n-1), the partial remission rate (PR) was 35% (n-35), and the median DOR was 12.6 months (95%: not .9.9 Based on the RECIST v1.1 standard evaluation, IIR determined that the ORR for the Keytruda-Lenvima combination treatment was 46% (n-46; 95% CI: 36.0-56.3), the full remission rate (CR) was 11% (n-11), the partial remission rate (PR) was 35% (n-35), and the median DOR was 8.6 months (95%: 6.6.N treatment-related adverse events (TRAE) resulted in 6% of patients disabling Keytruda and Lenvima, 10% of patients disabling Keytruda, and 14% of patients disabling Lenvima KEYNOTE-146/Study 111 RCC Queue Test Design and Data: KEYNOTE-146/Study 111 (NCT02501096) is an open label, one-arm Ib/II trial that is evaluating the efficacy of Keytruda-Lenvima's joint treatment of selected solid tumor patients Results from the Study Phase II Part RCC Cohort, based on 104 patients with metastatic ccRCC who received PD-1/PD-L1 immunocheckpoint inhibitor sympathising, were evaluated using the RECIST v1.1 standard In the study, patients received an intravenous dose of 200 mg of Keytruda every 3 weeks, while taking Lenvima 20 mg orally once daily until unacceptable toxicity or disease progression occurred The main endpoint of the study was the treatment of the ORR at week 24, which was reviewed and evaluated by the study's investigators in accordance with the immuno-related RECIST (irRECIST) criteria Secondary endpoints include ORR, no progression (PFS), total lifetime (OS), safety and tolerance of up to 35 cycles/efficacy (approximately 2 years) at the data cut-off (April 29, 2020), the results of the Phase II study showed that the study investigators determined, based on the irRECIST standard assessment, that the ORR at the 24th week of the keytruda-Lenvima combination therapy was 51% (95% CI: 41-61) The study's investigators assessed orRRs at 55% (95% CI: 45-65), partial remission (PR) at 55%, disease stability (SD) at 36%, and progression rate of 5% (5% unassessable) Median DOR is 12 months (95% CI: 9-18), median PFS is 11.7 months (95% CI: 9.4-17.7), 12-month PFS rate is 45% (95% CI: 32-57), median OS has not yet reached (NR; 95%CI: 16.7-NR), 12-month OS rate of 77%95-67% study investigators determined based on the RECIST v1.1 standard assessment that THE ORR was 52% (95% CI: 42-62), the PR was 52%, the SD was 38%, and the progression disease rate was 6% (5% unassessable) The median DOR is 12 months (95% CI:9-18) The median PFS was 11.3 months (95% CI: 7.6-17.7) and the 12-month PFS rate was 44% (95% CI: 31-55) treatment-related adverse events (TRAE) resulted in 15 percent of patients de-retiring Keytruda-Lenvima, 12 percent of patients disabling Keytruda, and 12 percent of patients disabling Lenvima Keytruda-Lenvima combination therapy is part of AmersaDon's strategic partnership with Wessa Oncology In March 2018, the two sides signed a $5.8 billion cooperation agreement to develop Lenvima single medicine and a combination of Keytruda drugs for the treatment of a wide range of types of tumors In addition to the ongoing assessment of keytruda and Lenvima combination treatments for several different types of tumors, including renal cell carcinoma, new clinical studies have been initiated through the LEAP clinical program and 13 different types of tumor (endometrial carcinoma, hepatocellular carcinoma, melanoma
Non-small cell lung cancer, renal cell carcinoma, head and neck squamous cell carcinoma, urinary skin cancer, bile duct cancer, triple negative breast cancer , colorectal cancer, stomach cancer, glioblastoma, ovarian cancer) a total of 18 clinical trials Lenvima is a targeted drug found and developed internally by Secroix, an oral multireceptor tyrosine kinase (RTK) inhibitor with a novel binding pattern that inhibits other promoters and cancer-causing signaling pathways in addition to inhibiting participation in tumor angiogenesis, tumor progression and of tumor immune modification and cancer-causing signaling pathway-related RTK (including platelet-derived growth factor (PDGF) receptor P In addition to DGFR alpha, KIT and RET), kinase activity can also be selectively inhibited in vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2, VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3, FGFR4) 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 human-derived 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 PD-(L)1 immunotherapy is a high-profile type of tumor immunotherapy designed to use the body's own immune system to fight cancer, by blocking the PD-1/PD-L1 signaling pathway to kill cancer cells, has the potential to treat a variety of types of tumors To date, 11 PD-1
1-
cancer
immunotherapy have been approved worldwide, with Keytruda being a leader in the field Mersadon has the largest clinical research program for immuno
oncology Currently, more than 1,000 clinical trials study Keytruda in a variety of cancer and treatment settings The project aims to understand the role of Keytruda in cancer treatment and to predict the factors that patients can benefit from Keytruda treatment, including exploring several different biomarker (biovalleybioon.com) original source: KEYTRUDA ® plus LEN®VATinib Combination Willd Clinically Meaningful Valley RateParent Response in UnresecTable Hepato Carcinoma and Ren AdvancedAl Carcinoma