IMMP Immutep

Immutep Completes Recruitment of Head and Neck Cancer Patients of Phase II TACTI-002 Study

Immutep Completes Recruitment of Head and Neck Cancer Patients of Phase II TACTI-002 Study

  • Completes recruitment of patients with 2nd line head and neck squamous cell carcinoma (HNSCC)
  • Recruitment of additional 1st line non small cell lung cancer (NSCLC) patients started
  • Further interim data from TACTI-002 expected in H1 2021

Sydney, AUSTRALIA, Jan. 07, 2021 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, is pleased to report it has enrolled and safely dosed the last patient for stage 2 of Part C of its TACTI-002 Phase II study.

This completes recruitment for Part C of the trial which evaluates 2nd line HNSCC patients being treated with Immutep’s lead product candidate, eftilagimod alpha (“efti” or “IMP321”) in combination with MSD’s KEYTRUDA® (pembrolizumab).

Immutep reported encouraging interim data from TACTI-002 at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary 2020 Annual Meeting on 10 November 2020. The data from 2nd line HNSCC patients was very robust and forms an excellent basis for additional clinical development in this indication.

Also the recruitment of an additional 74 patients with 1st line NSCLC in accordance with the TACTI-002 collaboration trial expansion plans announced on November 19th, 2020, has commenced with now 4 patients newly recruited, adding to the 36 patients already enrolled prior to the expansion. In total 40 of 110 patients with 1st line NSCLC have now been recruited in Part A of TACTI-002.

The Company expects to report more data from TACTI-002 in the first half of CY 2021.

About the TACTI-002 Trial

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® (pembrolizumab) in patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

More information about the trial can be found on Immutep’s website or on ClinicalTrials.gov (Identifier:NCT03625323).

About Immutep

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 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.

Further information can be found on the Company’s website or by contacting:

Australian Investors/Media:

Catherine Strong, Citadel-MAGNUS

+61 (0)406 759 268;

U.S. Media:

Tim McCarthy, LifeSci Advisors

+1 (212) 915.2564; 



EN
07/01/2021

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Immutep

 PRESS RELEASE

Immutep Quarterly Activities Report Q1 FY26

Immutep Quarterly Activities Report Q1 FY26 Media Release Pivotal TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in first line non-small cell lung cancer continues to build momentum and is recruiting patients at a growing number of activated clinical sites and countriesTrial in Progress poster for TACTI-004 presented at the World Conference on Lung Cancer (WCLC) 2025, where physician feedback continued to be encouragingPositive feedback received from the FDA regarding future late-stage clinical development of efti in first line head and neck cancer patients with...

 PRESS RELEASE

Primary Endpoint Met in EFTISARC-NEO Phase II Evaluating Neoadjuvant E...

Primary Endpoint Met in EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma and Data Presented at ESMO Congress 2025 Novel combination including eftilagimod alfa (efti) in neoadjuvant setting drives 51.5% tumour hyalinization/fibrosis in patients with soft tissue sarcoma (p

 PRESS RELEASE

Two Posters at ESMO Congress 2025 Highlight Immutep’s Focus on Changin...

Two Posters at ESMO Congress 2025 Highlight Immutep’s Focus on Changing Treatment Landscape in First Line Non-Small Cell Lung Cancer Novel combination of efti with KEYTRUDA® and chemotherapy generates strong response rates across all PD-L1 expression levels in first line non-small cell lung cancer (1L NSCLC) including 61.7% ORR in low & no PD-L1 (TPS

 PRESS RELEASE

Immutep Announces Successful Completion of FDA Project Optimus Require...

Immutep Announces Successful Completion of FDA Project Optimus Requirements Confirmation of 30mg efti as optimal biological dose relevant for Immutep’s oncology pipeline and potential future Biological License Applications (BLA)Registrational TACTI-004 (KEYNOTE-F91) Phase III trial in first line non-small cell lung cancer now in process of opening clinical sites in the United States SYDNEY, AUSTRALIA, Oct. 13, 2025 (GLOBE NEWSWIRE) -- (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces that p...

 PRESS RELEASE

Immutep Announces Update for TACTI-004 (KEYNOTE-F91) Phase III Trial i...

Immutep Announces Update for TACTI-004 (KEYNOTE-F91) Phase III Trial in First Line Non-Small Cell Lung Cancer Global Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount needed to conduct the futility analysisOver 100 clinical sites across 24 countries now activated and open for recruitment Futility analysis remains on track for completion in the first quarter of CY2026 SYDNEY, AUSTRALIA, Oct. 09, 2025 (GLOBE NEWSWIRE) -- (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company target...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch