Advanced kidney cancer "targeting and immune" first-line treatment! The BMS/Exelixis combination therapy Cabometyx and Opdivo III clinical success!

April 21, 2020 /
pr.
BIOON/ -- Bjour Mei squibb (BMS) and Exelixi Co., Inc recently jointly announced the evaluation of anti-PD-1 therapy Opdivo (Odivo, generic name: niumvol Ab, Navuriu monoantigen) joint target ingests the positive top line results of the key Phase III CheckMate-9ER study of the anti-cancer drug Cabozzantinib (cabozantinib, Cabotinib) on the first line of treatment for patients with advanced or metastatic renal cell carcinoma (RCC) CheckMate-9ER is an open label, randomized, multi-country Phase III clinical trial in patients with advanced or metastatic renal cell carcinoma (RCC) who were previously not treated (initial lyno) and were randomly divided into two groups on a 1:1 scale, one The group received a combination of Opdivo and Cabometyx, and the other group received late RCC first-line standard care drug Sutent (Sotan, generic name: Unitinib, sconeinib, a tyrosine kinase inhibitor developed by Pfizer) The main endpoints of the study were progression-free lifetime (PFS), and secondary endpoints included total lifetime (OS) and objective mitigation (ORR) The main efficacy analysis was to compare the Opdivo-Cabometyx combination with the sconetinib in all randomized patients The trial was sponsored by Baishi Squibb and Ono Pharmaceuticals, and co-sponsored by Exelixi, ip
en and Takeda Pharmaceuticals Co., Ltd results show that in the pre-specified mid-term analysis, the study has reached the primary endpoint of no progress(PFS) , as well as the secondary endpoint of total lifetime (OS) and objective mitigation rate (ORR) Analysis of the 's main efficacy showed that the compared to schoninine The Opdivo and Cabometyx combination stake showed clinically significant therapeutic results at all endpoints In the preliminary assessment, Opdivo and Cabometyx combined drug use showed good safety and reflected the known safety characteristics of immunotherapy and tyrosine kinase inhibitors (TKI) components in first-line treatment RCC renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, causing more than 140,000 deaths worldwide each year The incidence of RCC in men is about twice that of women, and is highest in North America and Europe Globally, patients diagnosed with metastatic or advanced kidney cancer had a five-year survival rate of only 12.1% In recent years, although some therapeutic progress has been made, additional treatment options are still needed to extend survival The results of the CheckMate-9ER study clearly demonstrate that Cabometyx and Opdivo's "targeted-and-immune" combination therapy program for advanced or metastatic RCC patients had clinically significant improvements in key efficacy indicators for no progression (PFS) and total survival (OS) A preliminary assessment of the data showed that Cabometyx and Opdivo were of good safety If approved, the Cabometyx-Opdivo "Target-plus-immune" combination will provide an important, new first-line treatment for patients with advanced or metastatic renal cell carcinoma who have not previously been treated According to the FDA Hematology/Oncology Approval Database, so far, two "targeted-and-immune" combination therapies have been approved for late-stage RCC, - april 2019, FDA approved anti-PD-1 therapy Keytruda (Paboli-beaded) and Inlyta (axitinib, axitiney) combination , based on the results of the key PHASE III study, based on the results of the key PHASE III STUDY : Compared to Sutent (Schonitinib), the Keytruda-Inlyta program reduced the risk of death by 47% (HR s.53, p.00005), reduced the risk of disease progression or death by 31% (HR?0.69, p-0.00012), objective mitigation rate (ORR) significantly (59% v 36%, p 0.0000) - In May 2019, the FDA approved anti-PD-L1 therapy
The Bavencio and Inlyta combinations , based on the results of the key Phase III study JAVENLIN Renal 101, which showed that in all prognostic risk groups (regardless of PD-L1 status), the Bavencio-Inlyta combination significantly reduced the risk of disease progression or death by 31% and the total mitigation rate (ORR) by nearly one(52.57%) compared to Sutent (Sutent) Cabometyx's active pharmaceutical ingredient is cabozantinib, a tyrosine kinase inhibitor (TKI) that acts against tumors by targeting MET, VEGFR2, and RET signaling pathways to kill tumor cells, reduce metastasis and inhibit angiogenesis In the United States, the European Union, Japan and other countries and regions of the world, Cabometyx has been approved for the treatment of patients with advanced renal cell carcinoma (RCC) as well as patients with liver cell carcinoma (HCC) who have previously been treated with orafenib 2016, Exelixi granted ip
en exclusive rights to commercialize cabozantinib and further clinical development outside the United States and Japan In 2017, Exelixi granted Takeda Pharmaceuticalco Co., Ltd exclusive rights for the commercialization and further clinical development of cabozantinib for all future indications in Japan Exilixi has exclusive rights to develop and commercialize cabozantinib in the United States Opdivo is a programmatic death-1 (PD-1) immunocheckpoint inhibitor that uniquely uses the human body to the autoimmune system to help restore the immune response to anti-
tumors
by blocking the interaction between PD-1 and its ligands Opdivo was the first PD-1 immunotherapy approved in Japan in July 2014 At present, Opdivo has become an important treatment option for a wide range of cancers For the treatment of renal cell carcinoma (RCC), Opdivo's approved indications are: (1) for advanced RCC patients who have previously received antiangiogenic therapy treatment, and (2) patients with critical or high-risk advanced RCC in first-line treatment with combined Yermumoy (ipiliab, eprimma, anti-CTLA-4 monoantigen) (BiovalleyBioon.com) original origin: Britol Myer Squibb and Exelixi Announce Topline Reult from Pivotal Phae 3Mate -9ER Trial EvaluatIng Opdivo ® (nivolumab) in with The MebjoMMETY®