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
- 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
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.
- As the data continue to mature, safety and tolerability of CTX-009 in combination with paclitaxel remain consistent with previous studies. Treatment emergent adverse events (TEAEs) were observed in all patients, including those TEAEs related to the patients’ disease and the two study drugs in the treatment regimen, paclitaxel and/or CTX-009. Grade 3 or greater TEAEs were reported in 95.8% of patients, including decreased neutrophil count (83.3%), hypertension (16.7%), anemia (20.8%) and decreased platelet count (12.5%).
The poster presentation will be available in the Pipeline section of the
Compass Therapeuticswebsite at www.compasstherapeutics.com.
“We are very pleased to see the maturing data from this study, particularly the median progression free survival of greater than 9 months and median overall survival of 12.5 months supporting the durable effect of CTX-009 in this patient population,” said
“The results from the Phase 2 trial in BTC continue to show the potential of CTX-009, which has demonstrated activity in a broad range of solid tumors. We are presently enrolling patients in two clinical studies of CTX-009 in
Investor Event Details
Compass will host a webcast on
CTX-009 Phase 2 BTC Study Design
The Phase 2 study is being conducted at four leading medical centers in
CTX-009 Phase 2/3 BTC Study Design
Compass has initiated a randomized Phase 2/3 study of CTX-009 in combination with paclitaxel in
Study details are on www.clinicaltrials.gov Identifier: NCT05506943
CTX-009 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Preclinical and early clinical data of CTX-009 suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer. Partial responses to CTX-009 as a monotherapy have been observed in heavily pre-treated patients with cancer who were resistant to currently approved anti-VEGF therapies.
Compass holds the global rights to CTX-009 (also known as ABL001) with the exception of rights in
About Biliary Tract Cancers
Biliary tract cancers (BTC) are a group of aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder, or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine).
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Compass’s product candidate, CTX-009, its development, regulatory plans with respect thereto and therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the
Source: Compass Therapeutics