Sydney-headquartered clinical-stage biotechnology company Immutep Limited (ASX: IMM) has received positive topline results from the TACTI-003 Phase IIb trial evaluating a cancer treatment candidate.
The study is looking at eftilagimod alfa (efti) in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as a first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients.
The trial enrolled 171 patients with any PD-L1 expression (Combined Positive Score [CPS] ≥1) and negative PD-L1 expression (CPS <1) at over 30 centres across the United States, Europe, and Australia.
Topline Results
Immutep’s MHC Class II agonist in combination with KEYTRUDA led to higher overall response rates in evaluable patients according to the primary endpoint of the study – across all levels of PD-L1 expression as compared to KEYTRUDA monotherapy.
In the overall evaluable TACTI-003 patient population (Cohort A and B), the response rate for efti in combination with KEYTRUDA was ~34% regardless of HPV status and PD-L1 expression, including patients with negative PD-L1 expression.
“It is encouraging to see efti safely drive higher response rates in combination with KEYTRUDA in the first line setting for head and neck squamous cell carcinoma patients, regardless of HPV status and levels of PD-L1,” Dr. Martin Forster of the UCL Cancer Institute and University College London Hospital said.
“The strong, consistent response rates, irrespective of whether patients have high, low, or negative PD-L1 expression, is intriguing and offers a glimpse into this novel combination’s ability to improve patients’ clinical responses and expand patient populations that benefit from anti-PD-1 therapy.”