Advanced kidney cancer "targeted and immune" first-line treatment! BMS / Exelixis combination therapy Cabometyx and Opdivo apply for listing in the United States!

!--, 2020 // -- Exelixis corporation recently announced that it has submitted a new drug supplement application (sNDA) to the U.S. Food and Drug Administration (FDA) targeting the cancer drug Cabomet. yx (cabozantinib, Cabotini) in combination with BMS anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab, Navuliyu monotherapy), first-line treatment of patients with advanced renal cell carcinoma (RCC).
the results of this sNDA based on the key Phase III CheckMate-9ER study.
data show that in previously untreated patients with advanced RCC, the "target-immune" treatment Cabomyx-Opdivo combined significantly extended progressive survival (PFS), total survival (OS) and improved objective remission (ORR) compared to the first-line standard care drug Suttent (soltan, generic name: sunitinib, shonithini, a tyrosine kinase inhibitor developed by Pfizer). "Based on the positive results of the critical Phase 3 CheckMate-9ER test, we are pleased to be able to complete the Cabometyx regulatory application for the first joint immunocheck inhibitor," said Dr. Gisela Schwab, President and Chief Medical Officer, Product Development and Medical Services,
Exelixis.
approved, Cabometyx-Opdivo will be an important, new first-line treatment for RCC patients.
we look forward to continuing to work closely with BST and the FDA during the regulatory review process.
"CheckMate-9ER is an open-label, randomized, multi-country Phase III clinical trial conducted in patients with advanced or metastasis RCC who had not previously been treated (primary treatment), who were randomly divided into two groups on a 1:1 scale, one receiving Opdivo in a joint treatment with Cabometyx and the other receiving the late RCC first-line standard care drug Sutent.
end point of the study is PFS, and the secondary endpoints include OS and ORR.
the main efficacy analysis was to compare opdivo-Cabometyx drugs with schoiniinibs in all randomized patients.
the trial was sponsored by Shimishi Shiguibo and Ono Pharmaceuticals, and co-financed by Exelixis, Ipsen and Takeda Pharmaceuticals Ltd.
results show that the study has reached the primary endpoint of PFS and the secondary endpoint of OS and ORR by the time of the pre-specified interim analysis.
results of the main efficacy analysis showed that Opdivo and Cabometyx combined showed clinically significant results at all endpoints compared to Schonithinib.
initial evaluation, Opdivo's combination with Cabometyx showed good safety and reflected known safety characteristics of immunotherapy and tyrosine kinase inhibitor (TKI) components in the first-line treatment RCC.
results of the CheckMate-9ER study will be presented at the upcoming 2020 annual meeting of the European Society of Oncology (ESMO) Network.
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 the first-line treatment of patients with advanced or metastasis RCC in Cabometyx and Opdivo's "targeted plus immune" treatment options has clinically significant improvements in key efficacy indicators for progressive lifetime (PFS) and total lifetime (OS).
preliminary evaluation of the data shows that Cabometyx and Opdivo combined drugs have good safety.
If approved, cabometyx-Opdivo's "targeted plus immune" combination will provide an important, new first-line treatment for previously untreated groups of patients with advanced or metastatic renal cell carcinoma.
according to the FDA Hematology/Oncology Approval Database, to date, two "targeted and immunological" combination therapies have been approved for first-line treatment with advanced RCC, respectively: - In April 2019, the FDA approved anti-PD-1 Therapy Keytruda (Paboli pearl monoanti) combined with Inlyta (axitinib, axitinib), this approval is based on the results of key Phase III study KEYNOTE-426, data show: with Suttent The Keytruda-Inlyta scheme reduced the risk of death by 47% (HR=0.53, p=0.00005) and the risk of disease progress or death by 31 %%(HR=0.69, p=0.00012), objective mitigation rate (ORR) significantly increased (59% vs 36%, p 0.0001).
- In May 2019, the FDA approved a combination of anti-PD-L1 therapy Bavencio (avelumab) and Inlyta, based on the results of the critical Phase III study JAVENLIN Renal 101, which showed that all prognostic risk groups (regardless of P D-L1 status), the Bavencio-Inlyta combination significantly reduced the risk of disease progression or death by 31% and nearly doubled the total remission rate (ORR) (52.5% vs. 27.3%) compared to Suttent.
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.
!--/ewebeditor:page--!--ewebeditor:page title"--In 2016, Exelixis granted ipsen exclusive rights to the commercialization and further clinical development of cabozantinib outside the United States and Japan.
2017, Exelixis granted Takeda Pharmaceuticals exclusive rights to the commercialization and further clinical development of cabozantinib for all future adaptations in Japan.
Exilixis has exclusive rights to develop and commercialize cabozantinib in the United States.
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.
treatment of renal cell carcinoma (RCC), Opdivo has approved the following adaptations: (1) for patients with advanced RCC who have previously been treated with anti-angiogenesis therapy;
Origin: Exelixis Announces Submissions of Supplemental New Drug Application to U.S. Food and Drug Administration for CABOMETYX? (cabozantinib) in Combin With Opdivo (nivolumab) for Advanced Renal Cell Carcinoma !--/ewebeditor: page--