FDA Grants Fast Track Designation to CTX-009 Plus Paclitaxel for Pretreated Biliary Tract Cancer
CTX-009 plus paclitaxel has received FDA fast track designation for pretreated metastatic or locally advanced biliary tract cancer. The FDA has granted fast track designation to CTX-009, a bispecific DLL4/VEGF-A antibody in combination with paclitaxel for the treatment of patients with metastatic or locally advanced biliary tract cancer following prior therapy.
“We are delighted that CTX-009 has received FDA fast track designation, highlighting the large unmet need in patients with advanced biliary tract cancer where current therapies have low, single-digit response rates, and limited effect on patient survival,” Thomas Schuetz, MD, PhD, cofounder, president of R&D, and vice chairman of the Compass board, said in a news release. “Our current study is evaluating the combination of CTX-009 with paclitaxel following the observation of 9 partial responses in 24 patients treated in our phase 2 study, leading to an overall response rate of 37.5% (n = 9/24), a median progression-free survival of 9.4 months and a median overall survival of 12.5 months. Compass remains on track to complete enrollment by mid-year and reporting top-line data by year end.”
CTX-009 is a bispecific antibody that blocks both DLL4 and VEGF-A signaling pathways, which are needed for angiogenesis and tumor vascularization. Preclinical and early clinical data have shown that blocking DLL4 and VEGF-A pathways with CTX-009 leads to antitumor activity in several solid tumors, including cholangiocarcinoma, pancreatic, colorectal, gastric, and non–small cell lung cancer. The agent also evoked partial responses as a single agent in heavily pretreated patients with VEGF-mediated resistance.
CTX-009 is currently under evaluation in the multicenter, open-label, randomized, phase 2/3 COMPANION-002 trial (NCT05506943).
The primary end point is best overall response according to RECIST v1.1 criteria. Secondary end points include progression-free survival, duration of response, overall survival, disease control rate, safety profile, patient-reported quality of life, and exposure response according to pharmacokinetic sampling.
Topline findings from the trial are expected by the end of 2024.
April 29, 2024
