Immutep (ASX:IMM), an Australian biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, has announced "mature positive efficacy" data from its TACTI-mel Phase 1 clinical study combining its lead product candidate, eftilagimod alpha ('efti' or 'IMP321') with MSD's KEYTRUDA (pembrolizumab) in metastatic melanoma.
The data was presented by Immutep chief scientific officer Dr Frédéric Triebel at the World Immunotherapy Congress as part of the Festival of Biologics 2019 being held in Switzerland.
“The combination therapy with efti shows very encouraging efficacy signals of synergy with KEYTRUDA along with a favourable safety profile so far in this high-risk patient population, said Dr Triebel.
"Patients are responding well to the combination treatment, their tumours are shrinking and not growing back over a long follow up period. In addition, we have seen the complete disappearance of all target tumour lesions for six patients plus one patient with a metabolic complete response on the PET-scan. The efficacy data is now final with a long follow up, the safety assessment is ongoing.”
TACTI-mel evaluated the combination of efti with anti-PD-1 therapy KEYTRUDA in 24 patients with unresectable or metastatic melanoma.
Patients participating in the trial had a very late stage of disease. All patients received subcutaneous injections of efti every two weeks, with a treatment duration of up to either six or 12 months.
The company said efti has a favourable safety profile in combination with KEYTRUDA with no dose-limiting toxicities and recorded an overall response rate of 58 per cent in 24 patients, 71 per cent recorded some tumour shrinkage while 58 per cent were progression-free at six months.