Following the release of encouraging clinical study findings, Compass Therapeutics, Inc. (NASDAQ: CMPX) stock is seeing a significant increase in value. CMPX shares were up 11.32%, trading at $2.11 as of the most recent market check. The company’s release of statistically significant top-line findings from its COMPANION-002 trial is what caused this increase.
Promising Efficacy Data for Tovecimig
In its Phase 2/3 randomized research, COMPANION-002, Compass Therapeutics (CMPX) revealed that tovecimig (formerly known as CTX-009) in combination with paclitaxel had excellent main efficacy endpoint outcomes for patients with advanced biliary tract cancer (BTC).
These findings demonstrate tovecimig’s potential to close a sizable therapeutic gap for BTC patients who are left with limited options after first-line treatment. Compass Therapeutics intends to discuss these findings with regulatory agencies soon.
Addressing an Urgent Medical Need
There are still few effective treatment options for biliary tract cancer, making it a difficult condition. Every year, almost 23,000 people receive a BTC diagnosis in the US alone. They lack FDA-approved second-line medicines because roughly 85% of patients lack tumors with actionable mutations that have authorized targeted therapies.
Current off-label treatment regimens in this setting yield a low objective response rate (ORR) of approximately 5% or less, with a median overall survival of just six months.
Encouraging Clinical Outcomes and Future Outlook
The COMPANION-002 study has reported an ORR of 17.1% for tovecimig in combination with paclitaxel, including one complete response, compared to 5.3% for paclitaxel alone. This 11.8% improvement in ORR was found to be statistically significant.
While the study is ongoing, secondary outcome analyses will be conducted once 80% of patients reach the necessary threshold of events, anticipated by Q3 2025. Compass Therapeutics expects to release detailed secondary endpoint data in Q4 2025. Additionally, the safety profile of tovecimig remains consistent with prior studies.
An independent Data Monitoring Committee (DMC) has reviewed the safety data across four separate meetings, each time recommending the study’s continuation without modifications. Compass Therapeutics (CMPX) anticipates reporting comprehensive safety data alongside secondary endpoint analyses in Q4 2025.