US FDA Grants Fast Track Designation to Compass Therapeutics’ CTX-009 with Paclitaxel for Previously Treated Metastatic or Locally Advanced Biliary Tract Tumors

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Compass received US FDA’s FTD for CTX-009 with paclitaxel to treat metastatic or locally advanced BTC patients that have been previously treated
Patients in P-II (n=24) study shown 37.5% (n=9/24) ORR, 9.4 mos mPFS, and 12.5 mos mOS; enrolment completion is expected by mid-2024; topline results of COMPANION-002 (P-II/III) study for BTC in US is expected by 2024 end
CTX-009, a bispecific DLL4/VEGF-A antibody has also shown partial response as monotx in pre-treated cancer patients resistant to other VEGF blockers, whereas current available therapies have low, single digit response rates, and limited effect on patient survival

Ref: Compass Therapeutics| Image: Compass Therapeutics

Related News:- Compass Therapeutics to Present P-II Study Results of CTX-009 + Paclitaxel for Biliary Tract Cancers at ASCO GI 2023

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