Advanced kidney cancer "immune and targeted" first-line treatment! BMS/ Exelixis combination therapy Opdivo and Cabometyx show significant survival benefits!

!-- Webeditor: page title-- September 21, 2020 // -- BMS and partner Exelixis recently unveiled the anti-PD-1 Therapy Opdivo (Odivo, generic name: nivolumab, navuliyu monoanti) combined to target the anti-cancer drug Cabometyx (cabozantinib, cabodinib) first-line treatment of advanced renal cell carcinoma (RCC) key Phase III CheckMate-9ER trial results.
results showed that in patients with advanced RCC who had not previously been treated, the first-line standard care drug Suttent (Sotan, generic name: sunitinib, shonithini, a tyrosine kinase inhibitor, developed by Pfizer In contrast, the "Immune-Targeted" Opdivo-Cabometyx program showed significant improvements at all ends of the efficacy, including total lifetime (OS), progress-free lifetime (PFS), objective mitigation rate (ORR), and mitigation duration (DOR).
specific data are: (1) OS, opdivo and Cabometyx group compared to the Sutt group significantly reduced the risk of death by 40% (HR s 0.60; 98.89% CI: 0.40-0.89; p s 0.0010), 2 groups of the mid-OS did not reach.
(2) study of the main endpoint PFS, the Opdivo-Cabometyx group doubled compared to the Sutt group (medium PFS: 16.6 months vs 8.3 months; HR=0.51; 95% CI:0.41-0.64; p 0.0001).
(3) ORR, the Opdivo-Cabometyx group is twice (56% vs. 27%) and the full mitigation rate (CR) is higher (8% vs 5%).
(4) DOR, the Opdivo-Cabometyx group is longer than the Sutt group (medium DOR: 20.2 months vs 11.5 months).
it is worth noting that all of these key outcomes are consistent in the pre-designated International Alliance for Metastatic Kidney Cancer Database (IMDC) risk and in the PD-L1 subgroup.
study, Opdivo and Cabometyx were well-to-do, reflecting the known safety of immunotherapy and tyrosine kinase inhibitors (TKI) in advanced first-line therapy RCC.
based on the National Cancer Comprehensive Network Cancer Treatment Function Assessment (NCCN-FACT) Kidney Symptoms Index 19 (FKSI-19), at most points, patients treated with Opdivo-Cabometyx had significantly better health-related quality of life than those treated with Sutt.
based on the findings, BMS and Exelixis partner Ipsen have submitted Category II change applications for Opdivo and Cabometyx to the European Medicines Agency (EMA), respectively.
September 12, the EMA verified the Category II change request, confirmed that the documents submitted had been completed, and initiated the EMA centralized review process.
addition, BMS and Exelixis recently completed their respective applications to the FDA. Dr Nick Botwood, interim director of oncology development at
BMS, said: "These data are another example of a combination of immunotherapy therapies that meaningfully extend the survival of patients with advanced cancer and reinforce our traditional potential in the field of genitourination.
Opdivo was the first immunodeficiline inhibitor to be approved as a second-line treatment for late-stage RCC, and then Opdivo-Yervoy was the first to be approved for first-line treatment of certain patients with advanced RCC.
with the strong results of the CheckMate-9ER study, we hope to bring opdivo and Cabometyx's highly effective combination therapies to the patient population of late-stage RCC patients.
" kidney cancer (Photo: vecteezy.com) Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, killing more than 140,000 people worldwide each year.
incidence of RCC in men is about twice that of women, with the highest incidence in North America and Europe.
, patients diagnosed with metastatic or advanced kidney cancer have a five-year survival rate of only 12.1%.
recent years, although some treatment progress has been made, additional treatment options are needed to extend survival.
CheckMate-9ER results clearly demonstrate that opdivo and Cabometyx "immune plus targeted" combined treatment options for patients with advanced or metastasis RCC were clinically significant improvements in key efficacy indicators for progressive lifetime (PFS) and total lifetime (OS).
addition, Opdivo and Cabometyx have good safety.
If approved, Opdivo and Cabometyx's "Immune Plus Targeting" combination will provide an important, new first-line treatment for previously untreated groups of patients with advanced or metastatic renal cell carcinoma (RCC).
Cabometyx's active pharmaceutical ingredient is cabozantinib, a tyrosine kinase inhibitor (TKI) that plays an anti-tumor role by targeting the suppression of MET, VEGFR2, and RET signaling path pathlines, killing tumor cells, reducing metastasis and inhibiting angiogenesis.
Cabometyx has been approved for the treatment of patients with advanced renal cell carcinoma (RCC) in the United States, the European Union, Japan and other countries and regions of the world, as well as for patients with hepatocellular carcinoma (HCC) who have previously been treated with sorafenib.
Opdivo is a programmed death-1 (PD-1) immuno-checkpoint inhibitor designed to uniquely use the body's own immune system to help restore the anti-tumor immune response by blocking the interaction between PD-1 and its liens.
first approved in Japan in July 2014 and is the world's first approved PD-1 immunotherapy.
, Opdivo has become an important treatment option for many cancers.
!-- /ewebeditor: page -- !--ewebeditor: page:title" -- Opdivo's approved accosis for the treatment of renal cell carcinoma (RCC) is: (1) For patients with advanced RCC who have previously been treated with anti-angiogenesis therapy; (2) patients with advanced RCC in the first-line treatment of Yervoy (ipilimumab, ipilimumab, anti-CTLA-4 monoantigen) .
() Original origin: Opdivo® (nivolumab) in With CABOMETYX® (cabozantinib) Shows Big Life Benefits in Patients with Advanced Renal Cell Carcinoma in Pivotal Phase 3 CheckMate -9ER Trial !--/ewebeditor:page--.