Catequentinib (AL3818) multitarget RTK inhibitor delivers 26.8% ORR with 18.3-mo mPFS in advanced ASPS (APROMISS)

Catequentinib hydrochloride (AL3818) is an oral multitargeted receptor tyrosine kinase inhibitor (anti-angiogenic TKI class) evaluated as monotherapy in the open-label, non-randomized ASPS cohort of the Phase 3 APROMISS study (NCT03016819) in adults with advanced/metastatic, molecularly confirmed ASPS (n=56; treatment-naive or previously treated, excluding prior cediranib). BICR-assessed ORR was 26.8% (1 CR, 14 PR; 95% CI 15.8–40.3), missing the prespecified 31% ORR threshold, but durability was long (median DOR 22.6 months) with mPFS 18.3 months and mOS 59.3 months; as a benchmark, cediranib monotherapy historically reported ~35% ORR in metastatic ASPS, while the FDA-approved atezolizumab label-supporting dataset reported ~24% ORR with durable responses—so AL3818’s ORR looks “in-family,” and the DOR/PFS signal is the main differentiator to watch. Safety showed a typical VEGF-TKI toxicity profile with grade ≥3 TRAEs in 48.2% and a grade 5 respiratory failure in 1.8%; high rates of diarrhea and hypertension were reported, so tolerability (and dose management) may be a meaningful trade vs PD-(L)1 monotherapy in this young population.