FDA Demands Survival Trial Before Tovecimig BLA, Delaying Compass Approval
CMPX is trading near its 52-week low of $1.61 (1.9% below the low).
Summary
The FDA has told Compass Therapeutics it must run a new trial demonstrating overall survival benefit before submitting a BLA for tovecimig in biliary tract cancer. Compass disagrees with the recommendation, based on COMPANION-002 study data and urgent unmet medical need, and intends to further engage with the FDA and continue preparing a BLA submission. The company had been positioning tovecimig for near-term filing based on strong PFS (HR 0.44) and ORR (18% vs 5.3%), but the FDA wants survival data, which the current trial did not show statistically significant improvement due to crossover. In the trial, tovecimig was evaluated in combination with paclitaxel for patients with previously treated, advanced biliary tract cancer, with median progression-free survival of 4.7 vs. 2.6 months, a p-value of <0.0001, and a 56% reduction in the risk of disease progression; objective response rate showed a p-value of 0.0228. Overall survival analyses were confounded by notably prolonged survival in crossover patients, and the safety profile was generally consistent with previously reported data. Compass remains confident based on subset analyses on survival and expects to present the complete COMPANION-002 dataset at a medical conference this year. The requirement adds years and significant cost to development, pushing any potential approval well beyond prior expectations. The stock is trading near its 52-week low, and this news likely pressures it further.
Updated with an SEC 8-K filing · What changed
Updates
· Benzinga — Compass shares fell 29.4% to $1.28, a new 52-week low, following the FDA's demand for a survival trial.
· SEC 8-K — Compass intends to further engage with the FDA and continue preparing a BLA submission, and expects to present the complete COMPANION-002 dataset at a medical conference this year.
- Efficacy Results — Median progression-free survival was 4.7 vs. 2.6 months, with a p-value of <0.0001 and a 56% reduction in the risk of disease progression. Objective response rate showed a p-value of 0.0228.
- Trial Design — Tovecimig was evaluated in combination with paclitaxel for patients with previously treated, advanced biliary tract cancer.
- Survival Analysis — Overall survival analyses were confounded by notably prolonged survival in crossover patients. Compass remains confident based on subset analyses on survival.
- Safety — The safety profile was generally consistent with previously reported data.
- Company Position — Compass's disagreement with FDA is based on COMPANION-002 study data and urgent unmet medical need. Compass's confidence in tovecimig is based on statistically significant improvements in ORR and PFS.
All 11 details
- Median progression-free survival (PFS) was 4.7 vs. 2.6 months.
- PFS showed a p-value of <0.0001.
- Objective response rate (ORR) showed a p-value of 0.0228.
- PFS represented a 56% reduction in the risk of disease progression.
- Overall survival analyses were confounded by notably prolonged survival in crossover patients.
- The safety profile was generally consistent with previously reported data.
- Tovecimig was evaluated in combination with paclitaxel.
- The trial was for patients with previously treated, advanced biliary tract cancer.
- Compass remains confident based on subset analyses on survival.
- Compass's disagreement with FDA is based on COMPANION-002 study data and urgent unmet medical need.
- Compass's confidence in tovecimig is based on statistically significant improvements in ORR and PFS.
At the time of this announcement, CMPX was trading at $1.58 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $327.8M. The 52-week trading range was $1.61 to $6.88. This news item was assessed with negative market sentiment and an importance score of 9 out of 10. Source: Wiseek News.