Cabozantinib extends PFS for patients with advanced neuroendocrine tumors
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Key takeaways:
- Researchers reported reductions in risk for disease progression or death with cabozantinib vs. placebo for both evaluated tumor types.
- The drug exhibited a safety profile consistent with prior reports.
Cabozantinib significantly improved PFS for patients with previously treated, progressive advanced extrapancreatic or pancreatic neuroendocrine tumors, according to phase 3 study results presented at ESMO Congress.
Limited treatment options are available for patients with advanced neuroendocrine tumors, according to study background.
Researchers conducted the CABINET trial to assess the efficacy and safety of cabozantinib (Cabometyx, Exelixis) for treatment of individuals with previously treated, progressive extrapancreatic or pancreatic neuroendocrine tumors.
The study included 298 patients who had received peptide receptor radionuclide therapy, targeted therapy or both.
Researchers created two cohorts. One included 203 patients with extrapancreatic neuroendocrine tumors, and the other included 5 patients with pancreatic neuroendocrine tumors.
Investigators randomly assigned patients 2:1 to 60 mg daily cabozantinib or placebo.
PFS assessed by blinded independent central review served as the primary endpoint. Objective response rate, OS and safety served as secondary endpoints.
Results, also published in The New England Journal of Medicine, showed longer median PFS with cabozantinib vs. placebo among patients with extrapancreatic neuroendocrine tumors (8.4 months vs. 3.9 months; HR = 0.38; 95% CI, 0.25-0.59) and those with pancreatic neuroendocrine tumors (13.8 months vs. 4.4 months; HR = 0.23; 95% CI, 0.12-0.42).
Researchers observed higher rates of confirmed objective response with cabozantinib among those with extrapancreatic neuroendocrine tumors (5% vs. 0%) and pancreatic neuroendocrine tumors (19% vs. 0%).
Grade 3 or higher adverse events occurred among 62% to 65% of patients assigned cabozantinib vs. 23% to 27% of those assigned placebo. The most common grade 3 or higher treatment-related adverse events among cabozantinib-treated patients included diarrhea, fatigue, hypertension and thromboembolic events.
References:
- Chan JA, et al. Abstract 11410. Presented at: European Society for Medical Oncology Congress; Sept. 13-17, 2024; Barcelona, Spain.
- Chan JA, et al. N Engl J Med. 2024;doi:10.1056/NEJMoa2403991.
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Chan JA, et al. Abstract 11410. Presented at: European Society for Medical Oncology Congress; Sept. 13-17, 2024; Barcelona, Spain.
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