The Alliance for Clinical Trials in Oncology today announced that an independent Data and Safety Monitoring Board (DSMB) determined that the phase III CABINET (A021602) pivotal trial met its primary endpoint at an interim analysis in both of the trial's cohorts, demonstrating statistically significant and clinically meaningful improvements in progression-free survival (PFS).
CABINET is evaluating cabozantinib compared with placebo in patients with either advanced pancreatic neuroendocrine tumors or advanced extra-pancreatic neuroendocrine tumors who experienced progression after prior systemic therapy. The DSMB recommended the study stop early due to efficacy and findings will be discussed with the U.S. Food and Drug Administration. Detailed results from the trial will be presented at an upcoming scientific meeting.
"These promising findings from the CABINET trial, in which cabozantinib showed an efficacy benefit for patients with pancreatic and extra-pancreatic neuroendocrine tumors, are welcome news and show the potential for cabozantinib to address important unmet needs for this community." . The results of CABINET add to this important work to further improve the outcomes of patients with the rare tumors of pancreatic and extra-pancreatic NET," said Suzanne George, MD, Interim Group Chair of the Alliance, Associate Professor of Medicine at Harvard Medical School and Clinical Director at the Center for Sarcoma and Bone Oncology at Dana-Farber Cancer Institute.
Patients were randomized 2:1 into the cabozantinib or placebo arms of the study in each of the two cohorts. Patients must have had measurable disease per RECIST 1.1 criteria and must have experienced disease progression after at least one FDA-approved line of prior therapy other than somatostatin analogs. The primary endpoint was PFS in each cohort.
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