Compass Therapeutics, Inc ( CMPX ). announced statistically significant topline data on Tuesday on the primary efficacy endpoint for COMPANION-002, the company’s ongoing Phase 2/3 trial of tovecimig (formerly CTX-009) in combination with paclitaxel in patients with advanced biliary tract cancer (BTC).

Biliary tract cancer is estimated to affect approximately 23,000 patients annually in the United States.

The study enrolled 168 adult patients.

All patients were dosed with 80 mg/m2 of paclitaxel on days 1, 8 and 15 of every 28-day cycle. Patients in the tovecimig arm were also dosed with 10 mg/kg of tovecimig on days 1 and 15 of each 28-day cycle.

The topline results show:

In patients with BTC in the second-line setting, tovecimig in combination with paclitaxel (19 of 111 patients) had a 17.1% overall response rate (ORR), including one complete response, compared to 5.3% for paclitaxel alone (3 of 57 patients).

This 11.8% relative improvement in ORR for those receiving the combination was statistically significant (p=0.031).

The study also showed differences between treatment arms for other efficacy measures, including progressive disease (PD) rates of 16.2% in patients on tovecimig combined with paclitaxel versus 42.1% in patients on paclitaxel alone.

The COMPANION-002 study is ongoing and the data are not yet mature for the secondary outcome measures (including PFS, OS and DoR) analyses.

The pre-specified number of events required to trigger the analyses of the secondary endpoints, including progression-free survival (PFS), overall survival (OS), and duration of response (DoR), has not yet been met due to fewer of these events occurring than were initially modeled. The company expects to report these endpoints in Q4 of 2025.

The safety profile of tovecimig is consistent with prior studies. An independent Data Monitoring Committee (DMC) has reviewed safety data at four separate (pre-specified) DMC meetings and, after each meeting, recommended the continuation of the study without modification.

The company expects to report detailed safety data with the analyses of secondary endpoints in Q4 2025.

Price Action: CMPX stock is up 14.7% at $2.18 at the last check Tuesday

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