Immutep Limited, a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, today announced new data from its ongoing TACTI-mel Phase I clinical trial. This study is evaluating the combination of eftilagimod alpha (“efti” or IMP321), Immutep’s lead product, in combination with pembrolizumab (KEYTRUDA®) in unresectable or metastatic melanoma patients that have had a suboptimal response or had disease progression with pembrolizumab monotherapy in the first three cohorts.
“The new data is very encouraging, further supporting our hypothesis that the combination of efti and pembrolizumab may be a hopeful solution for cancer patients,” said Marc Voigt, CEO of Immutep. “As advancements in PD-1 have enabled breakthroughs in immunotherapy, research is showing that LAG-3 has the potential to take immunotherapy to the next level, enabling more effective cancer treatments. We look forward to starting our new efti-pembrolizumab combination program in three different cancer indications as well as the results from the additional TACTI-mel patient cohort in the second half of this year.”
The multi-center, open-label clinical trial includes four cohorts of six patients each – for a total of 24 patients – testing different dosages of efti, including 1 milligram (mg), 6 mg and 30 mg, in combination with pembrolizumab. This latest data includes more mature data from the first two cohorts and the first data from the third cohort. Key findings were as follows:
- Long lasting and durable responses seen in a subset of patients;
- Overall Response Rate (“ORR”) of 61% (11/18 patients) when tumor size is measured starting from cycle 1 day 1 of pembrolizumab monotherapy and following combination therapy (combo starts at cycle 5) according to irRC; and
- Two complete responses related to the combination out of 18 patients according to RECIST.
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