Exelixis announced that the Alliance for Clinical Trials in Oncology independent Data and Safety Monitoring Board (DSMB) unanimously suggested to unblind and halt the Phase 3 CABINET trial of cabozantinib (CABOMETYX) based on dramatic improvement in efficacy.
The CABINET trial is assessing cabozantinib against placebo in patients with either advanced pancreatic neuroendocrine tumours (pNET) or advanced extra-pancreatic neuroendocrine tumours who showed progression after prior systemic therapy.
In an interim analysis, cabozantinib significantly prolonged the time without disease progression or death in both cohorts of the trial.
The drug’s safety profile observed in the trial was like its known safety profile, and no new safety signals were observed, Exelixis said.
The oncology company said that the detailed analysis will be presented at an upcoming medical meeting and will be discussed with the US Food and Drug Administration (FDA).
Exelixis Medical Affairs SVP Will Berg said: “As there is no standard of care for patients with advanced pancreatic or extra-pancreatic neuroendocrine tumours whose disease has progressed after prior therapy, we are pleased to see that cabozantinib improved outcomes for two additional patient populations living with advanced, difficult-to-treat cancers.
“We are grateful for the recommendation of the Data and Safety Monitoring Board to unblind the CABINET study early due to a dramatic improvement in efficacy and look forward to discussing these findings with the US Food and Drug Administration.”
CABINET trial is led by The Alliance for Clinical Trials in Oncology and sponsored by the National Cancer Institute (NCI).
It is a multi-centre, randomised, double-blinded, placebo-controlled phase 3 trial. CABINET recruited 290 patients in two separate cohorts in the US.
In the trial, the patients were randomised 2:1 into the cabozantinib or placebo arms of the study in each of the two cohorts.
The primary endpoint was defined as the progression-free survival in each cohort and key secondary endpoints included overall survival, radiographic response rate and safety.
In the US, CABOMETYX tablets are authorised for advanced renal cell carcinoma, hepatocellular carcinoma (HCC) and locally advanced or metastatic differentiated thyroid cancer (DTC).
In Japan, Takeda has exclusive rights to commercialise and further develop cabozantinib for all future indications.