Bispecific Antibody Fast Tracked for Advanced Biliary Tract Cancer

The Food and Drug Administration (FDA) has granted Fast Track designation to CTX-009 in combination with paclitaxel, for the treatment of patients with metastatic or locally advanced biliary tract cancer who have been previously treated.

CTX-009 is a bispecific antibody that simultaneously blocks Delta-like ligand 4 and vascular endothelial growth factor A signaling pathways. The designation is supported by data from an open-label, single-arm phase 2 study (ClinicalTrials.gov Identifier: NCT04492033), which evaluated the safety, tolerability, and pharmacokinetics of CTX-009 in combination with paclitaxel in patients with unresectable advanced, metastatic or recurrent biliary tract cancer (N=24).

Findings showed an overall response rate (ORR) of 37.5% (95% CI, 18.8-59.4). Median duration of response and progression free survival were 9.4 months for both endpoints. Median overall survival was 12.5 months.

CTX-009 is currently being evaluated in combination with paclitaxel in the phase 2/3 COMPANION-002 study (ClinicalTrials.gov Identifier: NCT05506943) in adults with unresectable advanced, metastatic or recurrent biliary tract cancers who have received 1 prior systemic chemotherapy regimen. Topline data are expected by the end of 2024. 

“We are delighted that CTX-009 has received FDA Fast Track Designation highlighting the large unmet need in patients with advanced BTC where current therapies have low, single digit response rates, and limited effect on patient survival,” said Thomas Schuetz, MD, PhD, Co-founder, President of R&D, and Vice Chairman of the Compass board.