Immutep (ASX:IMM) has announced positive efficacy and safety results from the TACTI-003 Phase 2b trial evaluating its eftilagimod alpha (efti) in combination with MSD’s KEYTRUDA (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma patients.
The results were presented at the European Society for Medical Oncology Congress by Dr Claus Kristensen.
Dr Kristensen said, "The efficacy and safety data in TACTI-003 are very encouraging and show the significant potential of this novel immunotherapy combination to fight difficult-to-treat head and neck squamous cell carcinomas.
"The clinically meaningful improvement in responses for patients with high PD-L1 expression in the randomised portion of the trial, combined with the compelling response rates in patients with no PD-L1 expression, are a testament to the complementary nature of efti in combination with KEYTRUDA.
"I am particularly impressed that these higher response rates and clear increase in biological activity seen in the efti arm do not come at the expense of durability of response or lead to an increased toxicity profile, which is often the case when combining therapies in the search for more efficacious treatments for cancer patients.”
Dr Frédéric Triebel, the chief scientific officer of Immutep, said, “Through multiple clinical trials, we see the promise of efti to not only improve cancer patients’ clinical responses to immune checkpoint inhibitors but also to expand patient populations who respond to them including patients with negative PD-L1 expression.
"Once again, the TACTI- 003 trial has reinforced efti’s positive impact on both these fronts.
"We are excited to see efti in combination with KEYTRUDA now driving a 1.9-fold increase in responses for head and neck cancer patients with high PDL1 expression as compared to KEYTRUDA alone, and a statistically significant increase in absolute lymphocyte count in the treatment arm showing efti’s biological activity in a randomised setting.”
Immutep CEO Marc Voigt added, “As we move into the latter half of 2024, we will continue to follow the data in TACTI-003 and start to engage with regulatory authorities regarding potential paths forward. We are certainly pleased with durability we are seeing, which is consistent with other trials in which efti combined with KEYTRUDA achieves a high DOR, unlike many other therapeutic combinations. We are hopeful this positive duration of response continues and, as seen in first line non-small cell lung cancer in the TACTI-002 trial evaluating efti in combination with KEYTRUDA, eventually contributes to an overall survival benefit for patients with first line head and neck cancer.”