Exelixis Announces Results From Subgroup Analysis of Phase 3 CABINET Pivotal Trial Evaluating CABOMETYX® (Cabozantinib) in Non-Functional and Functional Neuroendocrine Tumors at ASCO 2026

Key Takeaways

• Cabozantinib tripled PFS in non‑functional NET (9.4 vs 3.1 months).
• Functional NET doubled PFS with cabozantinib (12.7 vs 5.4 months).
• Hazard ratios: 0.26 (non‑functional) and 0.40 (functional) indicate strong benefit.
• Safety profile remained consistent; hypertension and fatigue were top grade 3/4 events.
• Trial supports CABOMETYX as leading oral therapy for previously treated advanced NET.

Pulse Analysis

Neuroendocrine tumors, though relatively rare, affect up to 200,000 Americans and present a therapeutic dilemma because they can be hormone‑producing (functional) or silent (non‑functional). Traditional options—somatostatin analogs, chemotherapy, peptide‑receptor radionuclide therapy—often provide modest disease control and can be limited by toxicity or resistance. Oral tyrosine‑kinase inhibitors have emerged as a valuable addition, offering systemic coverage with manageable side‑effects. Exelixis’ CABOMETYX, already approved for renal, liver and thyroid cancers, entered the NET arena with the CABINET trial, a rigorously designed, double‑blind, placebo‑controlled study that enrolled 298 patients across pancreatic and extra‑pancreatic disease sites.

The subgroup analysis disclosed striking PFS gains for both functional and non‑functional NET cohorts. Non‑functional patients experienced a threefold increase in median PFS (9.4 versus 3.1 months) and a hazard ratio of 0.26, while functional patients more than doubled their median PFS (12.7 versus 5.4 months) with a hazard ratio of 0.40. These figures surpass historical benchmarks for oral agents in this setting and suggest that cabozantinib’s multi‑targeted inhibition of VEGFR, MET and AXL pathways can curb tumor growth irrespective of hormone secretion status. Importantly, the safety signals mirrored the known profile, with hypertension and fatigue as the most common grade 3/4 events, reinforcing its tolerability for a population often burdened by symptom‑driven therapies.

From a commercial perspective, the results cement CABOMETYX’s position as the leading oral therapy for previously treated advanced NET, a market segment with limited competition. The data also lay groundwork for broader label expansion and may influence treatment sequencing, especially as Exelixis eyes its next‑generation kinase inhibitor, zanzalintinib, in the STELLAR‑311 trial. Investors and clinicians alike will watch how these findings translate into real‑world uptake, potentially reshaping the standard of care and delivering a much‑needed option for patients facing progressive, hormone‑related disease manifestations.