Compass Therapeutics, Inc.

Compass Therapeutics Announces Publication of Phase 2/3 COMPANION-002 Results for Tovecimig in the Journal of Clinical Oncology and Oral Presentation at ESMO 2026

Compass Therapeutics published positive Phase 2/3 COMPANION-002 results for tovecimig plus paclitaxel in advanced biliary tract cancer in the Journal of Clinical Oncology, with an ESMO 2026 oral presentation. The study met its primary endpoint with an ORR of 18.0% vs 5.3% for paclitaxel alone, and its key secondary endpoint with median PFS of 4.7 vs 2.6 months (HR=0.44), a 56% reduction in risk of progression or death. The intent-to-treat OS analysis was confounded by 54% crossover; a post hoc Two-Stage Estimation showed an OS hazard ratio of 0.85 that was not statistically significant (p=0.53). Management says it will continue working with the FDA toward approval; tovecimig holds Fast Track and Orphan Drug Designation but remains investigational.

•1d ago

Compass Therapeutics Reports 2026 Second Quarter Financial Results and Provides Corporate Update

Compass Therapeutics reported updated Phase 2/3 data for tovecimig showing an overall response rate of 18.0% versus 5.3% for the control arm, achieving a p-value of 0.0228. The company plans to engage the FDA this quarter regarding a potential BLA filing later this year and will present the full dataset at ESMO in October. Pipeline progression included the initiation of a Phase 2 study for CTX-471 in Q3 and the dosing of the first patients in the Phase 1 study of CTX-10726, with initial data expected in Q4. Additionally, cohort expansions for CTX-8371 are actively enrolling in triple-negative breast cancer, Hodgkin lymphoma, and non-small cell lung cancer. Financially, the company reported a net loss of $25.2 million for the second quarter, with cash and marketable securities totaling $180 million. This cash position is expected to fund operations into 2028.

•2mo ago

Compass Therapeutics Announces Tovecimig Data Accepted for an Oral Presentation at the ESMO Congress 2026

Compass Therapeutics announced that data from its Phase 2/3 COMPANION-002 trial evaluating tovecimig in combination with paclitaxel for advanced biliary tract cancer has been accepted for an oral presentation at the ESMO Congress 2026. The presentation will take place on October 24, 2026, and will be delivered by Dr. Nilofer Azad of Johns Hopkins University, highlighting results from the randomized, controlled study. Tovecimig is a proprietary DLL4 x VEGF-A bispecific antibody designed to modulate angiogenesis and the immune system within the tumor microenvironment.

•3mo ago

CMPX: 8-K · clinical trial

Compass Therapeutics announced positive top-line results from the Phase 2/3 COMPANION-002 trial evaluating Tovecimig in patients with second-line biliary tract cancer. The study met its primary endpoint, showing a statistically significant improvement in Overall Response Rate (ORR) of 18.0% for the Tovecimib combination compared to 5.3% for the control arm. The trial also achieved a key secondary endpoint, with Progression-Free Survival (PFS) improving to a median of 4.7 months versus 2.6 months for the control group. The company reported that the safety profile was consistent with prior studies and plans to submit a Biologics License Application (BLA) to the FDA in late 2026. Financially, Compass reported $195 million in cash and marketable securities as of the first quarter of 2026, providing a runway into 2028. The company is preparing for a potential commercial launch of Tovecimig in the second half of 2027.

SEC 8-K•3mo ago

Compass Therapeutics to Present Promising Phase 1 Clinical Data for CTX-8371 in Patients with Advanced Malignancies Treated in the Post-Checkpoint Inhibitor Setting at the 2026 ASCO Annual Meeting

Compass Therapeutics presented Phase 1 data for its PD-1/PD-L1 bispecific antibody CTX-8371 at the 2026 ASCO Annual Meeting, showing promising activity in patients with advanced malignancies resistant to prior checkpoint inhibitors. The study observed deep and durable responses in triple-negative breast cancer, Hodgkin lymphoma, and non-small cell lung cancer, with an overall response rate of 33% at the two highest dose levels. The drug was well tolerated with no dose-limiting toxicities, prompting the company to initiate cohort expansions in these three indications with additional data expected in Q4 2026.

•5mo ago

Tovecimig Demonstrates Statistically Significant Benefit in COMPANION-002 Randomized Phase 2/3 Study in Patients with Biliary Tract Cancer

Compass Therapeutics reported positive topline results from the COMPANION-002 Phase 2/3 study of tovecimig in biliary tract cancer, meeting the primary ORR endpoint and key secondary PFS endpoint. Median progression-free survival was 4.7 months for the combination versus 2.6 months for paclitaxel alone, representing a 56% reduction in the risk of disease progression with a hazard ratio of 0.44. Although the overall survival secondary endpoint did not reach statistical significance due to a high crossover rate, the company plans to meet with the FDA to discuss a Biologics License Application submission.

•5mo ago