Compass Therapeutics reports Phase 2/3 trial shows 56% lower risk of progression in advanced biliary tract cancer

Compass Therapeutics announced that its Phase 2/3 COMPANION-002 trial met its primary endpoint of overall response rate and the key secondary endpoint of progression‑free survival in patients with previously treated advanced biliary tract cancer. The combination of tovecimig and paclitaxel reduced the risk of disease progression or death by 56% and improved disease control rate to 62.2% versus 36.8% with chemotherapy alone. Safety was consistent with prior studies, with no new signals identified.

The company notes that the data, published in the Journal of Clinical Oncology and presented at ESMO, strengthen its case for FDA Fast Track and Orphan designations, which could accelerate development and review timelines. Analysts view the 56% risk reduction as supportive of clinical benefit and may improve investor sentiment toward the stock.

  • 1The randomized Phase 2/3 COMPANION-002 study enrolled 168 patients with advanced biliary tract cancer who had received one prior therapy.
  • 2The trial met its primary endpoint of overall response rate, with tovecimig plus paclitaxel achieving an ORR of 18.0% versus 5.3% for paclitaxel alone.
  • 3The key secondary endpoint of progression‑free survival showed a median of 4.7 months for the combination versus 2.6 months for control (HR = 0.44).
  • 4The combination reduced the risk of disease progression or death by 56% compared with paclitaxel alone.
  • 5Disease control rate was 62.2% with the combination versus 36.8% with paclitaxel alone.
  • 6Median duration of response was 4.9 months.

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