ASCO-GI – Exelixis opens up its Cabinet again

Exelixis is awaiting an FDA approval decision on Cabometyx in neuroendocrine tumours, and on Friday it reported more data from the supporting Cabinet trial at the ASCO Gastrointestinal Cancers symposium. The results came from patients with GI NETs, a subtype of extrapancreatic NETs; Cabometyx has already shown a PFS benefit in the latter. Zooming in on GI NETs shows a slightly less impressive result; in addition, there was only one partial response among Cabometyx-treated patients, albeit versus none in those receiving placebo. So far, the most emphatic data have come in pancreatic NETs, although neither pancreatic nor extrapancreatic patients saw an overall survival benefit with Cabometyx. The trial, which was unblinded early for efficacy, could have been confounded by a high rate of crossover and treatment with subsequent therapies. A decision in NETs is due by 3 April; the FDA had once been planning to discuss Cabinet at a March adcom but, according to an Exelixis press release in January, the study is no longer on the agenda. Cabometyx is marketed for renal, liver and thyroid cancers, and sold $1.6bn in 2023. It’s set to come off patent in 2030, with Exelixis facing doubts about its next-generation project, zanzalintinib.

Cabinet role? Evolving data with Cabometyx in NETs

NETs=neuroendocrine tumours; p=pancreatic; ep=extrapancreatic; GI=gastrointestinal. Source: NEJM & ASCO-GI 2025.