Prof Robin Lewis Jones talks to ecancer at ASCO 2025 about a randomized, double-blind phase III trial he presented data from.

This evaluated catequentinib hydrochloride (AL3818) versus placebo in patients with advanced or metastatic leiomyosarcoma (LMS) who required third-line or later treatment.

Among 110 treated patients, catequentinib significantly improved median progression-free survival (PFS) to 3.42 months compared to 1.41 months with placebo (HR 0.54; p=0.0265), with even greater benefit in those with ≤3 prior therapies. The 6-month PFS rate was doubled with catequentinib, and overall survival was comparable between arms including crossover patients.

Treatment-related adverse events were manageable, with diarrhoea, stomatitis, fatigue, and hypertension most common.

These results establish catequentinib as an effective and tolerable therapeutic option that improves disease control in metastatic or advanced LMS.