The Opdivo-Cabometyx program was approved by the U.S. FDA to beat Sutt

The U.S. Food and Drug Administration (FDA) has approved the anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab, navoliu monoanti) in combination with the anti-cancer drug Cabozinistb (Caboziniantb, cabotinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
medication, Opdivo is administered 240 mg once every 2 weeks or 480 mg intravenously every 4 weeks, and Cabometyx is given 40 mg tablets oral once a day. the
Opdivo and Cabomyx "Immune plus Targeting" combinations were approved through the Priority Review Program and the Real-Time Oncology Review (RTOR) pilot project for all international metastatic kidney cancer database alliance (IMDC) risk classifications, providing an important, new first-line treatment for the previously untreated group of advanced or metastatic RCC patients.
this approval to expand the position of Shishi Shiguibao in the first-tier late RCC.
, Opdivo and Yervoy (ipilimumab, Ipilimumma, anti-CTLA-4 monoantimmune) dual immunotherapy had been approved as standard therapies for patients with mid-risk or high-risk advanced RCC in first-line treatment. Adam Lenkowsky, U.S. general manager of oncology, immunology and cardiovascular disease at
, said, "At Hundred Merck, we focus on developing transformative drugs that improve the survival of cancer patients.
role of Opdivo-Yervoy in patients with high-risk advanced RCC in first-line treatment has been fully demonstrated, and today's achievements extend the potential of Opdivo-based combination therapy to more patients.
Opdivo and Cabometyx combine the fine traditions of these two drugs to provide doctors with a new late-stage RCC combination therapy that improves prognosis for patients with this immunotherapy plus tyrosine kinase inhibitor.
" approval, based on the results of the Key III CheckMate-9ER trial.
data show that in patients with advanced RCC who had not previously been treated, the first-line standard care drug Suttent (Sotan, generic name: sunitinib, schoinistinib, a tyrosine kinase inhibitor, developed by Pfizer) In contrast, the "Immune plus Target" scheme Opdivo-Cabometyx 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, the risk of death in the Opdivo-Cabometyx group was significantly reduced by 40% compared to the Sutt group (HR=0.60; 98.89% CI:0.40-0.89; p=0.0010), and the mid-OS in Group 2 was not achieved.
(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 combined therapy had good tolerance, 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.
(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 prolong the life.
CheckMate-9ER results clearly demonstrate that opdivo and Cabometyx "immune plus targeted" combined treatment options for advanced or metastasis RCC patients have clinically significant improvements in key efficacy indicators for progressive survival (PFS) and total lifetime (OS).
addition, Opdivo and Cabometyx have good safety.
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 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 lilogs.
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.
for the treatment of renal cell carcinoma (RCC), Opdivo has approved the following: (1) for patients with advanced RCC who have previously been treated with anti-angiogenesis therapy;