Exelixis announced positive results from a subgroup analysis of the phase 3 CABINET study, showing cabozantinib improved progression-free survival (PFS) compared to placebo in patients with advanced gastrointestinal (GI) neuroendocrine tumors (NET). This subgroup, comprising 116 of the 203 extra-pancreatic NET patients, represents a common and challenging-to-treat form of NET with limited treatment options after disease progression. The FDA is currently reviewing a supplemental New Drug Application for cabozantinib for the treatment of advanced NET.
This news is important because it provides clinicians with potential new treatment options for a patient population facing limited therapeutic choices. Advanced GI NETs represent a significant portion of neuroendocrine tumor cases, and effective therapies are crucial to improving patient outcomes. The positive PFS results suggest cabozantinib could address this unmet need and potentially become a standard of care.
In the subgroup analysis, cabozantinib reduced the risk of disease progression or death by 50% compared to placebo. Median PFS was 8.5 months with cabozantinib versus 5.6 months with placebo. The safety profile of cabozantinib in this subgroup was consistent with its known safety profile, with no new safety signals identified. The most common grade 3/4 adverse events included hypertension, diarrhea, and fatigue.
The positive results from this subgroup analysis strengthen the overall findings of the CABINET trial, which led to the trial being stopped early due to substantial PFS improvement. Pending FDA approval, cabozantinib could become a valuable new therapy for patients with advanced GI NET, offering a much-needed treatment option and potentially reshaping the treatment landscape for this challenging cancer type.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
