Compass Therapeutics Announces that the Phase 2 Data of CTX-009 in Combination with Paclitaxel in Patients with Biliary Tract Cancers (BTC) will be Presented at the ASCO GI Cancers Symposium on January 20, 2023
Compass to Host Investor Event on Monday, January 23rd at 8:30am ET
- 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
- Sub-group analysis showed that an ORR of 63.6% was observed in the 11 patients treated in the second-line setting compared with an ORR of 14.9% in the 13 patients treated in the third-line setting
- Median progression free survival (PFS) was 9.4 months and median overall survival (OS) was 12.5 months
- Safety and tolerability of CTX-009 were consistent with prior studies
- Compass has initiated a randomized Phase 2/3 trial of CTX-009 in combination with paclitaxel in the U.S. in patients with BTC. Depending on study results, this study may support a biologics license application (BLA) submission in 2024
Excerpt from the Press Release:
BOSTON, Jan. 19, 2023 (GLOBE NEWSWIRE) — Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced the presentation of data from a Phase 2 study of CTX-009 in combination with paclitaxel in patients with biliary tract cancers (BTC). These data will be presented at the 2023 American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium taking place in San Francisco, CA on January 20, 2023.
Data highlights from the poster presentation include:
- In the primary analysis of all 24 patients participating in the study, CTX-009 with paclitaxel demonstrated a 37.5% ORR based on 9 patients with Partial Responses (PRs) that were confirmed by RECIST 1.1. Importantly, of the 11 patients who had received one prior systemic therapy, 7 patients achieved a PR, leading to an ORR of 63.6% in this sub-group.
- After a median follow up of approximately 12 months, the median PFS was 9.4 months, and the median OS was 12.5 months. For reference, one regimen that has been studied in patients with advanced BTC is FOLFOX, the regimen recommended in the guidelines of the National Comprehensive Cancer Network (NCCN) for patients with BTC treated in the second-line setting. FOLFOX demonstrated a median PFS of 4.0 months and a median OS of 6.2 months in a randomized study against best supportive care.
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