K drug combined with LENVIMA treatment of advanced endometrial cancer III. Phase III clinical reached a double main endpoint

On December 16th, Mercadon and Japan's Aoshi jointly announced that the joint Phase III clinical trial KEYNOTE-775 / Study 309 was being treated in patients with advanced endometrial cancer who had previously received at least one platinum drug treatment Achieving the dual primary endpoints of total lifetime (OS) and progress-free lifetime (PFS), as well as the secondary efficacy endpoint of objective remission rate (ORR), is clinically significant compared to chemotherapy programmes, and this result will accelerate regulatory approval of the adaptation.
KEYNOTE-775/Study 309 is a multi-center, randomized, open Phase III clinical trial (ClinicalTrials.gov, NCT03517449) that evaluates the efficacy of patients with advanced endometrial cancer who have been treated with at least one platinum drug in the past.
according to RECIST v1.1, the two main endpoints of clinical trials are total survival and non-progressive lifetime, and secondary clinical endpoints include objective mitigation rate and safety/tolerance evaluation.
of the 827 patients in the group, 697 were tumor patients with non-microsatellitric high instability type (non-MSI-H) or misaligned repair function (pMMR), and 130 patients with microsatellitic high instability (MSI-H) or misaligned repair defect (dMMR).
patients were treated at random in 1:1 groups: KEYTRUDA (200 mg intravenously every three weeks, up to 35 cycles (approximately two years)) and LENVIMA (20 mg oral once a day); Chemotherapy (one of the TPC options chosen by the doctor: 60 mg/m2 of amycin is given intravenously every three weeks, with a maximum cumulative dose of 500 mg/m2 or a 28-day cycle of 80 mg/m2 intravenous injection of yew alcohol (three weeks of yew alcohol medication, one week suspended).
KEYNOTE-775 / Study 309 as a validated trial of KEYNOTE-146 / Study 111, this significant result will support the FDA's accelerated approval of the 2019 KEYTRUDA-LENVIMA combination therapy for patients with advanced endometrial cancer who have previously underwent systemic treatment and are not suitable for surgery or radiotherapy.
In addition, patients with advanced endometrial cancer who have under been initially treated throughout the body generally face high mortality rates and limited treatment options, and the results of the Phase III trial of the joint programme also give patients new hope and hope.
collaboration with Mercadon began in March 2018 with the global joint development and commercialization of LENVIMA® (lenvatinib, Levatinib), both as a single drug therapy and in combination with the PD-1 inhibitor Keytruda.
LENVIMA is a kinase inhibitor discovered and developed by Aochi to inhibit kinase activity in the endotrophic growth factor (VEGF) subjects VEGFR1 (FLT1), VEGFR2 (KDR) and VEGFR3 (FLT4).
LENVIMA is involved in tumor angiogenespheric, tumor cell growth, and cancer progression by inhibiting other kinases.
Existing adaptations are: for the treatment of invasive, differentiated thyroid cancer (DTC) patients, for patients who are still deteriorating after receiving radioactive iodine treatment (radioactive iodine incurable disease);
In addition to ongoing clinical studies evaluating the combination of KEYTRUDA and LENVIMA for several different tumor types, the two companies have launched other new clinical studies through the LEAP clinical program and are evaluating 13 different types in 20 clinical trials Treatment effects of tumor types (endometrial cancer, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, head and neck squamous cell carcinoma, urinary pathway cancer, biliary cancer, colorectal cancer, stomach cancer, glioblastoma, ovarian cancer and triple negative breast cancer).
source: KEYTRUDA ® Plus LENVIMA ® InStial In Life