Olverembatinib

Ascentage Pharma (NASDAQ: AAPG) reported four‑year Phase II data for olverembatinib in TKI‑resistant/intolerant chronic‑phase CML. Median event‑free survival was 21.2 months versus 2.9 months for best available therapy (P = 0.0159). Responses favored olverembatinib (85% CHR, 38% CCyR, 30% MMR). Safety was acceptable, with 7% vascular‑occlusion events and some grade ≥3 hematologic toxicities. The drug is approved in China and covered by the national reimbursement list; global rights depend on a Takeda option, and three Phase III registrational studies are underway.

Ascentage Pharma’s olverembatinib demonstrated promising Phase Ib results in SDH-deficient GIST, with an ORR of 23.1% and CBR of 84.6%. Median PFS reached 25.7 months. Translational analyses revealed CD36 overexpression and dysregulated lipid metabolism. Olverembatinib reduced CD36 and lipid uptake while inhibiting HIF, FGFR, and VEGFR pathways. It holds Breakthrough Therapy Designation in China. A global Phase III trial (POLARIS-3, NCT06640361) is ongoing.