First-line treatment of kidney cancer: Mercadon / Weishi "Immunity and Targeting" combination Keytruda and Lenvima Phase 3 Clinical: Efficacy beats Schoinidini!

February 14, 2021 // -- Merck . Co) and partner Eisai recently published the latest results of the key Phase 3 CLEAR study (KEYNOTE-581/307) at the 2021 American Society of Clinical Oncology's Urological System Cancer Symposium (ASCO-GU 2021), which was also published in the New England Journal of Medicine.
the study is evaluating the anti-PD-1 therapy Keytruda (Corida ®, common name: pembrolizumab, Pabli pearl monoantigen) and oral polysuper tyrosine kinase inhibitor Lenvima First-line treatment of patients with advanced renal cell carcinoma (RCC) and comparison with the Lenvima®Ivimos and sunitinib programmes.
results showed that Keytruda and Lenvima showed statistically significant improvements at multiple therapeutic endpoints compared to Schoini.
if approved, the "Immune plus Target" combination therapy Keytruda plus Lenvima will provide an important new treatment option for patients with first-line late-stage RCC and has the potential to change the clinical practice of first-line late-stage RCC.
CLEAR (NCT02811861) is a randomized, open-label Phase 3 clinical trial that is evaluating the treatment of patients with advanced renal cell carcinoma (RCC) on the first line of Keytruda-Lenvima, Lenvima-Evimos, and Schoini.
the trial included about 1,050 patients who were randomly assigned to three treatment groups and received: (1) Lenvima (20mg, oral, once daily) and Keytruda (200mg, intravenous infusion, every 3 weeks) ;(2) Lenvima (18mg, oral, once daily) and evymos (5mg, oral, once daily) ;(3) Schoinini (50mg, oral, once daily, treatment for 4 weeks and 2 weeks).
the main endpoints in this study were progress-free lifetime (PFS), and the key secondary endpoints include total lifetime (OS), objective mitigation rate (ORR), mitigation duration (DOR), and security.
results show that Keytruda-Lenvima reached the primary endpoint (PFS) and key secondary endpoint (OS and ORR): in the intentional therapy (ITT) study population, the Keytruda-Lenvima treatment group was in the PFS (HR-0.2) group compared to the Schoini group. 39, p<0.001), OS (HR=0.66, p=0.005), ORR (RR=1.97, p<0.001) have statistically and clinically significant improvements.
addition, Lenvima and Evimos also reached the main endpoint (PFS) and key secondary endpoint (ORR): in the ITT study population, the Lenvima plus Evimos group was in the PFS compared to the Schoini group. Statistically and clinically significant improvements in (HR=0.65, p<0.001), ORR (RR=1.48, p<0.001).
in an exploratory analysis, PFS and OS results were consistent in the pre-designated Sloan-Kettering Cancer Center (MSKCC) risk group (low-risk, medium-risk, high-risk).
the study, the safety of Keytruda and Lenvima, Lenvima and Evimex is consistent with previously reported studies.
kidney cancer (Photo: vecteezy.com) is independently reviewed according to version 1.1 of the Solid Tumor Efficacy Evaluation Standard (RECIST), as follows: (1) PFS, Keytruda and Lenvima Group and The Shoniteni group had a 61% reduction in disease progression or risk of death (HR-0.39, p<0.001), and significantly longer PFS (medium PFS: 23.9 months vs 9.2 months).
(2) OS, the keytruda-Lenvima group had a 34% lower risk of death (HR-0.66, p-0.005) than the Schoini group, with a median follow-up of 27 months and no median OS in 2 groups.
(3) ORR, the Keytruda-Lenvima group increased significantly compared to the Schoini group (71.0 vs. 36.1%; RR-1.97, p<0.) 001), the Keytruda-Lenvima group had a full mitigation rate (CR) of 16.1%, a partial mitigation rate (PR) of 54.9%, the Schoini group CR of 4.2% and pr of 31.9%.
(4) DOR, the middle DOR in the Keytruda-Lenvima group was 25.8 months and the Schoinitini group was 14.6 months.
in the second experimental treatment group of the trial, the data were as follows: (1) in terms of PFS, the Lenvima-Evimos group had a 35% reduction in disease progression or risk of death compared to the Schoinie group (HR=0.65, p<0.001), and a significant extension of PFS (middle PFS: 14.7 months vs 9.2 months).
(2) OS, there was no improvement in the Lenvima-Evimos group compared to the Schoini group (HR-1.15, p-0.3), with a medium follow-up of 27 months and no mid-OS in 2 treatment groups.
(3) ORR, the Lenvima-Evimos group increased significantly compared to the Schoini group (53.5% vs 36.1%, RR s 1.48, p <0.001), Lenvima-Evimo group CR was 9.8%, PR was 43.7%, Schoini group CR was 4.2% and PR was 31.9%.
(4) DOR, the middle DOR in the Lenvima-Yvimos group was 16.6 months and the Schoinitini group was 14.6 months.
keytruda-Lenvima combination therapy is part of Mercadon's strategic collaboration with Avant-Gareth Oncology.
March 2018, the two sides signed a $5.8 billion cooperation agreement to develop Lenvima monodrima and a combination with Keytruda for the treatment of multiple types of tumors.
Lenvima is an oral polymethyme tyrosine kinase (RTK) inhibitor with novel binding patterns that inhibit other angiogenesphage and cancer-causing signaling pathogenesies associated with thyroid-derived growth factors (PDGs) in addition to inhibition of other angiogenesphageal, tumor progression, and tumor immunomodulation. In addition to PDGFR alpha, KIT and RET, the F) and fibroblast growth factor (FGFR1, VEGFR2, VEGFR3) and fibroblast growth factor (FGFF) are selectively inhibited by kinase activity of vascular enditer growth factor (VEGFR3, 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 an anthogeneic monoclonal antibody that blocks the interaction between PD-1 and its mediators PD-L1 and PD-L2, activating T lymphocytes that may affect tumor cells and healthy cells.
Currently, Mercadon and Isashi are developing 14 different types of tumors (endometrial, hepatocellular, melanoma, non-small cell lung, renal cell carcinoma, The Keytruda-Lenvima combination continued to be studied in 20 clinical trials of head and neck squamous cell carcinoma, urethra cancer, bile tube cancer, colorectal cancer, stomach cancer, glioblastoma, ovarian cancer, pancreatic cancer, and triple-negative breast cancer.
two trials of the LEAP project, published in September 2020, showed that the Keytruda-Lenvima combination showed efficacy in all seven types of tumors.
() Original origin: KEYTRUDA® Plus LENVIMA® (lenvatinib) Progress Superior Progression-Free Survival (PFS) and Overall Survival (OS) Versussusinib as First-Line Treatment for Patients With Advanced Renal Cell > Carcin<!--