Immutep (ASX:IMM) has announced positive results from a Phase 2b trial of its eftilagimod alfa (efti) in combination with MSD's KEYTRUDA (pembrolizumab) for head and neck cancer.
The company said the combination achieved median overall survival of 17.6 months in Cohort B of the TACTI-003 (KEYNOTE-C34) Phase 2b trial evaluating efti in combination with KEYTRUDA as first-line therapy in recurrent or metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with PD-L1 expression below one.
Immutep said the mature 17.6-month median overall survival in evaluable patients (N=31) with a data cut-off of 31 March 2025 compares favourably to historical results from the two current standard-of-care approaches for the cancer, including 7.9 months for anti-PD-1 monotherapy.
“We are excited to see this strong survival benefit for head and neck cancer patients with such cold tumours. Combining these two complementary immunotherapies has led to a 7-fold increase in response rates and a more than doubling of median overall survival as compared to historical results from anti-PD-1 monotherapy. Driving durable responses that translate into clinically meaningful survival holds tremendous promise for these patients in need of more tolerable and efficacious therapies,” said Immutep CEO Marc Voigt.
“There is a high unmet need in 1L HNSCC patients with cold tumors and PD-L1 CPS <1, due to the lack of an approved immunotherapy-only treatment regimen and a lack of competitor trials with chemotherapy-free approaches targeting this patient population. Given the strength of the efficacy and safety results generated to date with efti in combination with pembrolizumab, we will meet with regulators to discuss next steps and potential paths to approval,” added Mr Voigt.
The FDA has granted efti fast track designation in 1L HNSCC. Immutep said it has requested a meeting with the agency to discuss next steps, including potential paths to approval.
