Double PFS, ORR, 40% lower risk of death! FDA approves Cabotinib's joint Opdivo first-line treatment for kidney cancer

On January 22, Exelixis announced FDA approval for Cabometyx (Cabotinini) joint Opdivo (Navuliyu monomatosis) first-line treatment for advanced renal cell carcinoma (RCC).
Last August, Exelixis submitted a listing application to the FDA for Cabotinib's combined Navuliyu single-anti-first-line treatment of late-stage RCC, which was reviewed by the FDA using Real-Time Review of Oncology Drugs (PTOR) and Fast Track, a month ahead of the February 20 PDUFA scheduled date.
approval is based primarily on data from open label, multi-center, critical Phase III CheckMate-9ER studies.
results showed that cabotinib-Navulyu monoantitor (n-323) as a first-line therapy compared to schoinib (n-328) can double the PFS in patients with advanced RCC (16.6 vs. 8.3 months, HR-0.51), 95% CI 0.41-0.64, p.lt;0.0001), reached the main destination.
addition, cabodinib and Navuliyu mono-resistance group ORR doubled (56% vs 27%, p-lt;0.0001), while significantly improving the total survival of the patient (HR-0.6,98.89% CI: 0.40-0.89, p-0.001), both groups of mid-level OS have not yet matured.
consistent efficacy results were also observed in subgroup analysis based on the International Alliance for Metastatic Renal Cell Carcinoma Database (IMDC) risk score and PD-L1 expression levels.
data were presented at the ESMO2020 conference in September.
safety, Cabotinib and Navuliyu have good single resistance, and the safety profile is consistent with previously reported results of the first-line treatment of advanced RCC for TKI and IO therapy. More than 20% of the most common adverse reactions in
include diarrhea, fatigue, liver toxicity, abnormal feeling of red blood cells in the palm, stomatitis, rash, hypertension, hypothyroidation, musculoskeletal pain, loss of appetite, nausea, stuttering, abdominal pain, cough and upper respiratory tract infections.
RTOR is a major innovative new cancer drug approval policy that the FDA will begin implementing in 2018, with the hope of estring patients' access to a breakthrough treatment that is as effective and safe as possible in a more effective way.
the RTOR system requires the applicant to apply for itself, allowing the applicant to submit the application before the entire clinical trial is completed, so it can take only a few weeks from the completion of the application to approval.
kabotinib and Opdivo are the only combination therapies that can double the total survival of patients with late-stage RCC compared to Schoinini compared to ORR.
approval is a milestone for such patients.
kidney cancer is one of the top ten most common tumors in both men and women in the United States, about 90 percent of which are renal cell carcinomas, according to the latest 2021 statistics from the American Cancer Society.
if confirmed at an early stage, the five-year survival rate was higher in RCC patients, but in patients with late-stage or end-stage metastasis RCC, the five-year survival rate was only about 13 percent.
70 percent of patients with renal cell carcinoma are histologically transparent cell carcinoma.
the expression of von Hippel-Lindau in most transparent cell RCC tumors is lower than normal, which leads to high expression of proteins such as MET, AXL, VEGF, which induces angiogenesic, growth, invasion and metastasis of tumors.
about 32,000 patients with advanced kidney cancer in the United States will need systematic treatment by 2021, and about 71,000 patients worldwide will need systematic treatment.
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