Immutep Announces Data from Ongoing TACTI-mel Phase I Clinical...

Immutep Announces Data from Ongoing TACTI-mel Phase I Clinical Trial in Unresectable or Metastatic
Melanoma
Presented at the World Immunotherapy Congress USA 2019
SYDNEY, AUSTRALIA – 6 March 2019 - Immutep Limited (ASX: IMM; NASDAQ: IMMP) (Immutep or the
Company), a biotechnology company developing novel immunotherapy treatments for cancer and
autoimmune diseases, today announced positive, more mature data from its ongoing TACTI-mel phase I
clinical study of the Company’s lead product candidate, eftilagimod alpha (“efti” or “IMP321”. The data
will be presented at the World Immunotherapy Congress 2019 in San Diego USA, by Dr. Frédéric Triebel,
Immutep’s Chief Scientific Officer and Chief Medical Officer at 3:00 PM Pacific Standard Time on 5th
March 2019.
The TACTI-mel study is evaluating the combination of efti with anti-PD-1 therapy KEYTRUDA®
(pembrolizumab) in 24 patients with unresectable or metastatic melanoma. It is a multi-center, open-
label clinical trial that involves four cohorts of six patients, each cohort testing different dosages of efti,
including 1 milligram (mg), 6 mg and 30 mg, in combination with pembrolizumab.
Part A of the study is starting the combination therapy at cycle 5 of the pembrolizumab treatment in
three cohorts with a treatment duration of 6 months. Part B of the study includes a 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.
Key findings from the ongoing trial were as follows:
Part A (starting cycle 5 of pembro therapy)
N=18
Part B (starting day 1 cycle 1 of pembro therapy)
N=6
Overall
Response
Rate (ORR)
33% (61%*) 50%
Disease
Control Rate
(DCR)
66% 66%
*Exploratory ORR when tumour size is measured according to irRC from day 1 of cycle 1 of
pembrolizumab and following combination therapy (which starts at cycle 5 of prembrolizumab
treatment).
Safety results (total n=24):
• Efti has very favorable safety profile in doses up to 30 mg administered s.c. every 2 weeks;
• Combination with PD-1 antagonists is feasible without dose limiting toxicity (DLTs) or reaching MTD;
and
• No DLT or new safety signal have been observed in either part of the study.
Notes to the results
Part B
• All patients high risk with 100% M1c status, 83% elevated LDH and 50% ECOG 1;
• Very deep responses with 1 patient having complete disappearance of target lesions at 3 months
already; and
• Treatment is ongoing (6+ months) in 4 patients.
Part A
• Late stage (78 % M1C stage, 38 % elevated LDH) patients sub-optimally responding to
pembrolizumab monotherapy;
• Long lasting and durable responses (up to 30 months) continue to be observed in a subset of
patients, 4 patients still in PFS follow-up; and
• Tumor shrinkage in 56% of patients incl. 2 patients with complete disappearance of all target
lesions.
The full presentation slides from this event can be accessed via Immutep’s website.
Immutep CSO and CMO, Frédéric Triebel, CEO, Marc Voigt and Director of Clinical Development,
Christian Mueller will discuss the data, along with the clinical development program for IMP321,
including other trials, on a global webcast in the coming weeks. Details of the webcast will be
announced separately.
About the TACTI-mel clinical trial
The ongoing TACTI-mel (Two ACTive Immunotherapies in melanoma) 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).
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