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ASX/Media Announcement Immutep Reports Positive Phase II TACTI-002 Data Increasing benefit reported from patients with first line Non-Small Cell Lung Cancer (NSCLC): Improving Overall Response Rate (ORR) of 53% (earlier

Key Takeaway: ASX/Media Announcement Immutep Reports Positive Phase II TACTI-002 Data SYDNEY, AUSTRALIA April 28, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or the Company ), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, a

Full Press Release Details

ASX/Media Announcement
Immutep Reports Positive Phase II TACTI-002 Data
SYDNEY, AUSTRALIA April 28, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or the
Company ), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, announces further positive interim data from its ongoing Phase II TACTI-002 study. The data
relates to the data cut-off date of 20 March 2020 and shows improving efficacy results.
being presented today as a poster short talk audio presentation as part of the high-impact paper presentation program by TACTI-002 Principle Investigator, Dr Martin Forster of University College London
Hospitals NHS Foundation at the American Association for Cancer Research (AACR) Virtual Annual Meeting.
is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada). It is evaluating the combination of the Company s lead product candidate eftilagimod alpha
( efti or IMP321 ) with MSD s KEYTRUDA (pembrolizumab) in up to 109 patients with second line HNSCC or NSCLC in first and second line.
Immutep CSO and CMO, Dr Frederic Triebel said: These very positive results for stage 1 demonstrate the benefits for NSCLC
patients in receiving efti in combination with pembrolizumab. 53% of patients are now responding and we expect PFS to be more than 9 months. These consolidated results, with more tumour responses being confirmed by a second CT-scan and a longer follow up, are remarkable given that usually only 20% of patients respond to pembrolizumab monotherapy, if not pre-selected for high PD-L1 expression. It is also encouraging to see that 33% of HNSCC patients are responding, almost double the proportion that respond to pembrolizumab monotherapy and that the median PFS hasn t yet been reached
Immutep CEO, Marc Voigt stated: Efti is showing remarkable results for patients with NSCLC and HNSCC. These are
multi-billion-dollar markets, with NSCLC expected to reach US$33.9 billion and HNSCC US$2.8 billion by 2026 respectively1. As the treatment duration continues, we will update ORR and
PFS, positioning the Company strongly to advance efti in these indications.
Level 12, 95 Pitt Street, Sydney NSW 2000
Key Findings (Data cut-off: 20 March 2020)
Stage 1 Part A (1st line NSCLC, N=17):
Patients by PD-L1 category No. of Responses 2 ORR 1 Frequency in TACTI-002 N (%) 3 Historical 4 Distribution
Low (< 1%) 1 33 % 3 (23 %) 35 %
Medium (1-49%) 3 50 % 6 (46 %) 35 %
High ( 50%) 3 75 % 4 (31 %) 30 %
NE 5 2 50 % 4 (n/a ) n/a
Overall 9 52.9 % 17
Level 12, 95 Pitt Street, Sydney NSW 2000
Stage 1 Part C (2nd line HNSCC):
The combination treatment continues to be safe
and well tolerated with no new safety signals reported thus far.
TACTI-002 Recruitment Update
Trial recruitment continues to progress well, with 76 patients out of up to 109 already enrolled at 12 clinical sites across Australia, Europe, the UK and US.
Recruitment details for each Part are below and are current as at the date of today s announcement (not the data cut-off date of 20 March).
Stage 1 (N) Actual/target Stage 2 (N) Actual / target
Part A (1st line NSCLC) 17/17 17/19
Part B (2nd line NSCLC) 18/23 -/13
Part C (2nd line HNSCC) 18/18 6/19
AACR Virtual Annual Meeting
A replay of the audio poster presentation with the presentation slides entitled, Initial results from a phase II study
(TACTI-002) in metastatic non-small cell lung or head and neck carcinoma patients receiving eftilagimod alpha (soluble lag-3
protein) and pembrolizumab , is available on the Company s website at www.immutep.com.
TACTI-002 (Two ACTive Immunotherapies) is being
conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada). The study is evaluating the combination of efti with MSD s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients with second line head and neck squamous cell
carcinoma or non-small cell lung cancer in first and second line.
Level 12, 95 Pitt Street, Sydney NSW 2000
The trial is a Phase II, Simon s two-stage, non-comparative, open-label,
single-arm, multicentre clinical study that is taking place in up to 12 study centres across the U.S., Europe, UK and Australia.
Patients participating in three Parts:
TACTI-002 is an all comer study in
terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC. PD-L1 expression is typically reported in three
groups for NSCLC: < 1%, 1-49% and 50% (Tumour Proportion Score or TPS). Patients with a high PD-L1 status are typically
more responsive to anti-PD-1 monotherapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly
less responsive. Pembrolizumab monotherapy is registered in the US and the EU for first-line NSCLC patients with a TPS score 1% (US) and 50% (EU), reflecting
65% and 30% of all first line NSCLC patients, respectively.
More information about the trial can be found on Immutep s website or on
ClinicalTrials.gov (Identifier: NCT03625323)
Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related
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-3 protein (LAG-3Ig) 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 being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada) referred to as
TACTI-002 to evaluate a combination of efti with KEYTRUDA (pembrolizumab) in several different solid tumours (clinicaltrials.gov identifier
NCT03625323); a Phase I clinical trial being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. referred to as INSIGHT-004 to evaluate a combination of efti with avelumab
(clinicaltrials.gov identifier NCT03252938); and a Phase I combination therapy trial in metastatic melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT02676869).
Level 12, 95 Pitt Street, Sydney NSW 2000
Additional LAG-3 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.
This announcement was authorised for release by the board of Immutep Limited.
Further information can be found on the Company s website www.immutep.com or by contacting:
Australian Investors/Media:
+61 (0)406 759 268; cstrong@citadelmagnus.com
Garth Russell, LifeSci Advisors
+1 (646) 876-3613; garth@lifesciadvisors.com
Level 12, 95 Pitt Street, Sydney NSW 2000
Last updated: Apr 28, 2020