Full Press Release Details
Immutep Reports Positive Final Data from the
INSIGHT-004 Phase I Study of LAG-3 Therapy, Efti, at ASCO
SYDNEY, AUSTRALIA 4 June 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP)
( Immutep or the Company ), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, announces encouraging final data from its
Phase I INSIGHT-004 study.
The data will be presented in a poster presentation by Dr Thorsten Goetze, Krankenhaus
Nordwest, University Cancer Center Frankfurt, Germany at the American Society of Clinical Oncology s (ASCO) 2021 Annual Meeting in an on-demand session available from 9 am on 4 June 2021, US Eastern
Time at this year s virtual conference. The poster will also be made available on Immutep s website from that time at:
INSIGHT-004 is evaluating the combination of Immutep s lead product candidate, eftilagimod alpha ( efti
or IMP321 ) with avelumab (Bavencio ), an anti-PD-L1 antibody, in 12 patients with different solid
tumours. It is being conducted under Immutep s collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., which are co-developing and co-commercialising
avelumab. INSIGHT-004 is the fourth arm (Stratum D) of the investigator-initiated INSIGHT trial which is conducted by the Institute of Clinical Cancer Research (IKF) in Frankfurt, Germany.
Immutep CSO and CMO, Dr Frederic Triebel said: The final results of the INSIGHT-004 study show promising
activity signals from efti in combination with avelumab in a variety of solid cancers, primarily gastrointestinal. Overall, 41.7% of patients responded to the therapy and half showed disease control. Importantly, it continues to be well tolerated.
These encouraging results are supportive of further clinical evaluation of this new combination, efti plus anti-PD-L1 therapy.
Prof Salah-Eddin Al-Batran, INSIGHT-004 trial investigator and Director of
IKF said: Efti and avelumab could represent a potent combination for enhancing the immune system in patients with different solid tumours. We are particularly encouraged to see the deep and durable responses in patients with solid tumors
including PD-L1-negative cancers.
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Final Results Summary
| Tumor response according to RECIST 1.1 | Total N (%) Total (N=12) | |
| Complete Response (CR) | 0 (0) | |
| Partial Response (PR) | 5 (41.7%) | |
| Stable Disease (SD) | 1 (8.3%) | |
| Progressive Disease (PD) | 6 (50.0%) | |
| Objective Response Rate (ORR) | 5 (41.7%) | |
| Disease Control Rate (DCR) | 6 (50%) |
treatment of efti and avelumab in this trial is well tolerated with no dose limiting toxicities, building on efti s strong safety profile to date.
The final efficacy and safety data from INSIGHT-004 is promising and warrants further clinical evaluation of this new combination, efti plus anti-PDL-1 therapy, with distinct
INSIGHT-004 is the fourth arm of the investigator-initiated INSIGHT trial, which is being conducted by the Institute of
Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt. It is being conducted under Immutep s collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., and is evaluating the safety, tolerability and recommended Phase II
dose of efti when given in combination with avelumab. It is the first combination trial of an approved and marketed anti-PD-L1 drug and efti.
Patients in cohort 1 received 6mg doses of efti every two weeks for six months with the standard dose of avelumab (800 mg every two weeks), while patients in
cohort 2 received a higher dose of efti, 30 mg, with avelumab for six months. Thereafter, patients enter the maintenance phase and received avelumab monotherapy.
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.
Level 12, 95 Pitt Street, Sydney NSW 2000
Immutep s current lead product candidate is eftilagimod alpha ( efti or IMP321 ),
a soluble LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting
cell (APC) activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease. Additional LAG-3
products, including antibodies for immune response modulation, are being developed by Immutep s large pharmaceutical partners.
can be found on the Company s website www.immutep.com or by contacting:
Australian Investors/Media:
Catherine Strong, Citadel-MAGNUS
McCarthy, LifeSci Advisors
+1 (212) 915.2564; tim@lifesciadvisors.com
This announcement was authorised for release by the Board of Immutep Limited.
Level 12, 95 Pitt Street, Sydney NSW 2000