The independent Data Monitoring Committee has unanimously recommended that a Phase 3 clinical trial, OPTIMA, evaluating Celsion’s (CLSN -11.8%) ThermoDox plus RFA (radiofrequency ablation) in hepatocellular carcinoma (primary liver cancer) patients continue as planned.
The data review showed that median progression-free survival (PFS) reached 17.3 months as of August, though this is a secondary endpoint.
Investors appear disappointed with the company’s statement on overall survival (OS), the primary endpoint, saying combined OS for both treatment arms is “consistent” with that observed in the Phase 3 HEAT study (which failed to show enough of a treatment benefit) subgroup of 285 participants who received at least 45 minutes of RFA therapy. In a February 2015 statement, the company said ThermoDox + RFA extended OS 59% compared to RFA alone in this population. At data cutoff in OPTIMA, though, median follow-up for survival was only 25 months, too early for estimates. Median follow-up in HEAT was 67 months.
The next data readout should happen in Q2 2020. The hazard ratio for success is 0.70 based on 158 patients deaths, below the ratio of 0.65 observed in the 285 patients cited above.
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