- Compass Therapeutics Inc CMPX announced the presentation of data from a Phase 2 study of CTX-009 in combination with paclitaxel in patients with biliary tract cancers (BTC).
- CTX-009, in combination with paclitaxel, demonstrated a 37.5% overall response rate (ORR) in 24 patients with BTC treated in the second-and third-line settings.
- At least one response was observed in each of the four anatomical subtypes of BTC.
- Seven of the 11 patients who had received one prior systemic therapy achieved a Partial Response, leading to an ORR of 63.6% in this sub-group.
- After a median follow-up of approximately 12 months, the median progression-free survival was 9.4 months, and the median overall survival was 12.5 months.
- Compass has initiated a randomized Phase 2/3 study of CTX-009 in combination with paclitaxel in the U.S. in patients with advanced BTC.
- The study will enroll up to 150 patients with BTC who have received no more than one prior systemic therapy.
- The study could support a biologics license application (BLA) submission as soon as H2 2024. The primary endpoint of the study is ORR.
- Price Action: CMPX shares closed 10.93% lower at $3.75 on Thursday.
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