Positive New Data from Ongoing TACTI-mel Study in Unresectable or Metastatic Melanoma Presented in Global Webcast
May 30 2018 - 8:00AM
New data presented shows ORR of 61% (11/18
patients)
Immutep Limited (ASX:IMM) (NASDAQ:IMMP) ("Immutep“ or “the
Company“), 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.
The data is being presented in more detail via a global webcast
today at 8am Australian Eastern Standard Time / 6pm US Eastern
Daylight Time. Investors can access the webcast via the following
link:
https://fnn.webex.com/fnn/onstage/g.php?MTID=edd0388586f757aa2ea7d890e6193f64a
An audio replay of the webcast will be made available on the
Company’s website.
A subset of this new data was presented by Dr. Frédéric Triebel,
Immutep’s Chief Scientific Officer and Medical Officer, at the 3rd
Annual Advances in Immuno-Oncology Congress on May 25.
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, dosing
escalating (1, 6 or 30 mg of eftilagimod alpha or “efti”) study
evaluating the combination of efti with pembrolizumab for 6 months,
starting at treatment cycle 5 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). The initial study
consists of three cohorts of six patients.
In February 2018, Immutep expanded the TACTI-mel study by an
additional cohort of 6 patients at 30 mg of efti in combination
with pembrolizumab starting at cycle 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 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 NCT
02614833) and a Phase I combination therapy trial in metastatic
melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT
02676869). Additional LAG-three products, including antibodies, for
immune response modulation in autoimmunity and cancer are being
developed by Immutep’s large pharmaceutical partners. Immutep is
also developing an agonist of LAG-3 (IMP761) for autoimmune
disease.
Further information can be found on the
Company’s website www.immutep.com or by contacting:
U.S. Investors:Jay Campbell,
Vice President of Business Development and Investor Relations,
Immutep Limited+1 (917) 860-9404; jay.campbell@immutep.com
Australian
Investors/Media:Matthew Gregorowski, Citadel-MAGNUS+61 2
8234 0105; mgregorowski@citadelmagnus.com
U.S. Media:Sharon Golubchik,
Antenna Group+1 (201) 465-8008; sharon@antennagroup.com
Immutep (NASDAQ:IMMP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Immutep (NASDAQ:IMMP)
Historical Stock Chart
From Jul 2023 to Jul 2024