| | • | | Exploratory 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 (which starts at cycle 5 of pembrolizumab treatment) according to irRC; and | |
| | • | | No new safety signals have been observed. | |
“We are very pleased by this initial data which further supports our hypothesis that the combination of efti and pembrolizumab may be a hopeful solution for cancer patients,” said Frederic Triebel, CSO and CMO of Immutep. “Based on these encouraging results we are looking forward to the start of our TACTI-002 trial where exactly this combination will be tested in three different cancer indications.”
The presentation slides are available on the Company’s website athttps://www.immutep.com/investors-media/presentations.html
About the TACTI-mel clinical trial
The ongoing TACTI-mel (TwoACTive Immunotherapies inmelanoma) Phase I clinical trial is a multi-center, open-label study evaluating the combination of eftilagimod alpha (“efti”) with pembrolizumab, in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pembrolizumab monotherapy (clinicaltrials.gov identifier NCT 02676869).
Part A of the study is dosing escalating (1, 6 or 30 mg of efti), starting the combination treatment at cycle 5 in three cohorts of six patients with a treatment duration of 6 months. Part B of the study includes an additional cohort of 6 patients at 30 mg of efti in combination with pembrolizumab, starting at cycle 1, day 1 and with a treatment duration of 12 months.
About Immutep
Immutep is a globally active biotechnology company that is a leader in the development of immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.
Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3Ig fusion protein based on the LAG-3 immune control mechanism. This mechanism plays a vital role in the regulation of the T cell immune response. Efti is currently in a Phase IIb clinical trial as a chemoimmunotherapy for metastatic breast cancer termed AIPAC (clinicaltrials.gov identifier NCT02614833); a Phase II clinical trial referred to as TACTI-002 (Two ACTive Immunotherapies) to evaluate a combination of Efti with KEYTRUDA® (pembrolizumab) in several different solid tumours (clinicaltrials.gov identifier NCT03625323); a planned Phase I clinical trial referred to as INSIGHT-004 to evaluate a combination of Efti with avelumab (clinical trials.gov identifier NCT03252938); and a Phase I combination therapy trial in metastatic melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT02676869).
