Cabozantinib (Cabometyx)-new indication approved

On September 17, 2021, Exelixis announced that the FDA approved Cabometyx (cabotinib) for the treatment of children and adults 12 years of age and older with locally advanced or recurrent metastatic differentiated thyroid cancer (DTC) who have progressed after prior VEGFR-targeted therapy and are ineligible for or resistant to radioactive iodine therapy.

In addition, Cabozantinib (Cabometyx) is also approved for:

-The treatment of patients with advanced renal cell carcinoma (RCC)

-In combination with Opdivo® (nivolumab) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

-Patients with hepatocellular carcinoma (HCC) who have been treated with sorafenib (Nexavar®).

Thyroid cancer is the most common malignant tumor of the endocrine system. Differentiated thyroid carcinoma (DTC) accounts for more than 95% of all thyroid cancers, mainly including papillary carcinoma, follicular carcinoma, Hürthle cell carcinoma and poorly differentiated carcinoma. In recent years, the incidence rate of thyroid cancer has continued to rise, ranking fourth among malignant tumors in women in 2019. With the continuous development of standardized diagnosis and treatment, the 5-year relative survival rate of thyroid cancer in my country has increased to 84.3%.

Cabometyx’s approval for the new indication is based on COSMIC-311, a randomized, double-blind, placebo-controlled study of patients with locally advanced or metastatic DTC who have progressed after prior VEGFR-targeted therapy and are refractory to or ineligible for radioactive iodine. Patients were randomized to Cabometyx or placebo and given supportive care until disease progression or unacceptable toxicity. The main efficacy indicators are progression-free survival (PFS) and overall response rate (ORR). The preliminary analysis included 187 randomized patients. The latest analysis included 258 randomized patients.

-In preliminary analysis, median PFS was not reached with Cabometyx compared with 1.9 months with placebo [(HR) 0.22, 95% CI: 0.14, 0.35; p<0.0001]. The ORRs were 15% (95%CI: 7,26) and 0% (95%CI: 0.0,11) respectively (p=0.0281).

-In the latest analysis, the median PFS was 11.0 months in the Cabometyx group and 1.9 months in the placebo group (HR0.22, 95% CI: 0.15, 0.31). The ORRs were 18% (95%CI: 10,29) and 0% (95%CI: 0.0,11) respectively.

Reference:

1.xa0FDA Cabometyx Instructions for Use

2. Chinese Expert Consensus on Postoperative Management of Differentiated Thyroid Cancer (2020 Edition)