Cabozantinib

Cabozantinib was evaluated in a randomized, double-blind, placebo-controlled, phase III trial (EXAM [NCT00704730]). The study included 330 patients with metastatic MTC and radiographic progression of disease. Patients were randomly assigned in a 2:1 ratio to receive cabozantinib (140 mg per day) or placebo. Patients who received placebo were not permitted to cross over to cabozantinib. The primary end point was PFS. Additional outcomes included response rate, OS, and safety.[12][Level of evidence B1]

Cabozantinib was evaluated in a randomized, double-blind, placebo-controlled, phase III trial (EXAM [NCT00704730]). The study included 330 patients with metastatic MTC and radiographic progression of disease. Patients were randomly assigned in a 2:1 ratio to receive cabozantinib (140 mg per day) or placebo. Patients who received placebo were not permitted to cross over to cabozantinib. The primary end point was PFS. Additional outcomes included response rate, OS, and safety.[12][Level of evidence B1]

The estimated median PFS was 11.2 months in the cabozantinib group and 4.0 months in the placebo group (HR, 0.28; 95% CI, 0.19‒0.40; P < .001). A difference in PFS was observed across all subgroups and was independent of previous tyrosine kinase inhibitor treatment and RET pathogenic variant status.

Cabozantinib was evaluated in a randomized, double-blind, placebo-controlled, phase III trial (EXAM [NCT00704730]). The study included 330 patients with metastatic MTC and radiographic progression of disease. Patients were randomly assigned in a 2:1 ratio to receive cabozantinib (140 mg per day) or placebo. Patients who received placebo were not permitted to cross over to cabozantinib. The primary end point was PFS. Additional outcomes included response rate, OS, and safety.[12][Level of evidence B1]

During a planned interim analysis of OS, no statistically significant difference was observed between the two groups (HR, 0.98; 95% CI, 0.63‒1.52).

Cabozantinib was evaluated in a randomized, double-blind, placebo-controlled, phase III trial (EXAM [NCT00704730]). The study included 330 patients with metastatic MTC and radiographic progression of disease. Patients were randomly assigned in a 2:1 ratio to receive cabozantinib (140 mg per day) or placebo. Patients who received placebo were not permitted to cross over to cabozantinib. The primary end point was PFS. Additional outcomes included response rate, OS, and safety.[12][Level of evidence B1]

The objective response rate was 28% in the cabozantinib group (all partial responses) and 0% in the placebo group (P < .001). The median estimated duration of response was 14.6 months (95% CI, 11.1‒17.5 months). Responses were observed regardless of RET pathogenic variant status.

Cabozantinib was evaluated in a randomized, double-blind, placebo-controlled, phase III trial (EXAM [NCT00704730]). The study included 330 patients with metastatic MTC and radiographic progression of disease. Patients were randomly assigned in a 2:1 ratio to receive cabozantinib (140 mg per day) or placebo. Patients who received placebo were not permitted to cross over to cabozantinib. The primary end point was PFS. Additional outcomes included response rate, OS, and safety.[12][Level of evidence B1]

The most common cabozantinib-associated adverse events (all grades) included diarrhea (63.1%), palmar-plantar erythrodysesthesia (50%), decreased weight (47.7%), decreased appetite (45.8%), nausea (43%), and fatigue (40.7%)

Cabozantinib was evaluated in a randomized, double-blind, placebo-controlled, phase III trial (EXAM [NCT00704730]). The study included 330 patients with metastatic MTC and radiographic progression of disease. Patients were randomly assigned in a 2:1 ratio to receive cabozantinib (140 mg per day) or placebo. Patients who received placebo were not permitted to cross over to cabozantinib. The primary end point was PFS. Additional outcomes included response rate, OS, and safety.[12][Level of evidence B1]

Grade 3 or 4 adverse events were reported in 69% of patients in the cabozantinib group and 33% of patients in the placebo group.

Cabozantinib was evaluated in a randomized, double-blind, placebo-controlled, phase III trial (EXAM [NCT00704730]). The study included 330 patients with metastatic MTC and radiographic progression of disease. Patients were randomly assigned in a 2:1 ratio to receive cabozantinib (140 mg per day) or placebo. Patients who received placebo were not permitted to cross over to cabozantinib. The primary end point was PFS. Additional outcomes included response rate, OS, and safety.[12][Level of evidence B1]

Adverse events resulted in treatment discontinuation in 16% of patients who received cabozantinib and in 8% of patients who received placebo.