Key development
Immutep Limited reported that an Independent Data Monitoring Committee (IDMC) has recommended the discontinuation of the TACTI-004 Phase III trial. The study, which was evaluating eftilagimod alfa - known as efti - in patients with first-line non-small cell lung cancer (NSCLC), was stopped following a futility analysis. On the news, Immutep's shares fell 80% on Friday.
Reason for stopping
According to the company, the IDMC reviewed the available safety and efficacy data and determined the trial should be discontinued for futility. Immutep said it will immediately halt enrollment and implement an orderly wind down of the study. That process will include continued patient follow-up and site close-out activities in line with regulatory and ethical obligations.
Company response and next steps
Immutep's chief executive, Marc Voigt, said the company was disappointed and surprised by the outcome, noting this result contrasted with efti's performance in other clinical trials. The firm is conducting a comprehensive review of the available study data to determine the appropriate next steps for the program.
The company also said that, following the discontinuation of the TACTI-004 study, it now expects its cash runway to extend well beyond its prior guidance of the second quarter of 2027. Immutep plans to provide an updated cash runway outlook after it completes operational assessments and a full analysis of the study data.
Analyst reactions
Market analysts moved quickly to adjust their views. Baird analyst Colleen Kusy downgraded Immutep from Outperform to Neutral and revised the price target to $1.00 from $7.00. Citizens analyst Reni Benjamin downgraded the stock from Market Outperform to Market Perform, and removed all revenues that had been modelled for the NSCLC indication.
Analysts noted that other clinical trials of efti in different indications remain ongoing, but they expect the shares to trade in line with the broader market until meaningful randomized study results are reported.
Context for investors
Investors should expect an extended period of data review and operational assessment as Immutep completes patient follow-up and site close-out. The company has signalled it will update the market on a revised cash runway once the internal review and operational assessments are complete.