Data from the TACTI-003 trial, specifically Cohort B, which focuses on first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) patients with negative PD-L1 expression, has shown a preliminary overall response rate (ORR) of 26.9% and a disease control rate (DCR) of 57.7% in 26 patients. This data, according to RECIST 1.1, compares favorably to historical controls.
Dr. Martin Forster, a TACTI-003 Investigator, highlighted the significance of these results, especially for patients with tumours that do not express PD-L1 and those unable to receive chemotherapy. The combination of efti with KEYTRUDA® offers a promising avenue to potentially improve clinical responses and expand the patient population that responds to treatment without the use of chemotherapy.
Efti, Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist, is under evaluation for its ability to stimulate both innate and adaptive immunity in the treatment of cancer. Its unique mechanism of action, which includes the activation and proliferation of various immune cells and the upregulation of key biological molecules, positions it as a valuable component in combination therapies, particularly with anti-PD-(L)1 immunotherapy.
The TACTI-003 trial is ongoing, with data collection, cleaning, and analysis continuing. The company anticipates reporting the primary endpoint, including overall response rate according to RECIST1.1, from Cohorts A & B in the first half of 2024. This trial represents a significant step forward in addressing the high unmet medical need in HNSCC, a challenging and aggressive form of cancer associated with significant psychological distress and compromised quality of life.
