CS5001 is so far the first anti-ROR1 ADC known to show clinical anti-tumor activity in both solid tumors and lymphomas. The data presented at ASH highlighted the latest safety and efficacy of CS5001 as a monotherapy for patients with advanced lymphomas.CS5001 is well tolerated in heavily pre-treated patients with advanced B-cell lymphoma. No dose-limiting toxicity (DLT) has been reported up to dose level 10 (DL10).Encouraging anti-tumor activity with high objective response rate (ORR) was observed regardless of ROR1 expression levels, starting from the effective dose, in advanced Hodgkin lymphomas (HLs) (ORR=60.0%) and non-Hodgkin lymphomas (NHLs) (ORR=56.3%). At the preliminary recommended Phase 2 dose (RP2D) of DL8 (125 μg/kg), a notably higher ORR of 76.9% was observed in advanced B-cell lymphoma, including 3 evaluable HL cases with complete or partial response, and an ORR of 70% in NHL.The global multicenter Phase 1 trials of CS5001 are currently in progress in the USA, Australia, and China. Dose escalation has been completed with ongoing backfilling of patients for selective DLs. A Phase 1b dose-expansion study across multiple tumor types with registration potential is expected to be initiated soon.

SUZHOU, China, Dec. 8, 2024 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, announced today the presentation of the latest clinical data for CS5001, an anti-ROR1 ADC and one of the leading assets in CStone Pipeline 2.0, at the 66th American Society of Hematology (ASH) Annual Meeting. These data highlight the compound's potential as a treatment for lymphoma.

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