It looks like it will be a day to forget for owners of Immutep Ltd (ASX: IMM) shares on Friday.
In morning trade, the ASX biotech stock is down a massive 93% to 2.8 cents.
Image source: Getty Images
Why is this ASX biotech stock having a day to forget?
Investors have been rushing to the exits in their droves on Friday after the late-stage biotechnology company released an update on the TACTI-004 Phase III study.
TACTI-004 is a randomised, double-blind, controlled Phase III study evaluating eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with Merck & Co's anti-PD-1 therapy, KEYTRUDA, and chemotherapy.
It is being evaluated as a first-line therapy for patients with advanced or metastatic non-small cell lung cancer with no EGFR, ALK or ROS1 genomic tumour aberrations.
Patients were being randomised 1:1 to receive either efti in combination with pembrolizumab and chemotherapy in the treatment arm or pembrolizumab in combination with chemotherapy and placebo in the control arm. The study's dual primary endpoints were progression-free survival and overall survival.
What's the latest?
This morning, the ASX biotech stock revealed that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III study has recommended the discontinuation of the trial following a planned interim futility analysis in accordance with the study protocol.
This followed a review of the available safety and efficacy data.
In response to the IDMC's recommendation, Immutep advised that enrolment in the study will be halted and the company will implement an orderly wind-down of the study, including appropriate patient follow-up and site close-out in accordance with regulatory and ethical obligations.
Commenting on the news, the ASX biotech stock's CEO, Marc Voigt, said:
We are very disappointed and surprised with the outcome of the futility analysis, in light of efti's performance in every other clinical trial. We would like to thank the patients, investigators, and clinical teams who contributed to this important study. We are currently conducting a comprehensive review of the available data to better understand the results and determine the appropriate next steps for the program.
Is it game over?
The company advised that despite this massive setback, it remains focused on advancing its pipeline of therapies including efti.
Following the discontinuation of TACTI-004, Immutep now anticipates its cash runway will be extended well beyond the previously guided timeframe of the second quarter of 2027, which was set prior to the trial's cessation.
It intends to provide an updated outlook on its revised cash runway and will reassess capital allocation priorities once operational assessments and a full analysis of the study data have been finalised.
