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Immutep Reports Promising New Data in Head and Neck Cancer at ESMO Immuno-Oncology 2024 Data shows strong overall survival, progression-free survival, and durability from novel combination of efti in combination with pem

Key Takeaway: Immutep Limited announced promising clinical results from its TACTI-003 Phase IIb trial at the ESMO Immuno-Oncology 2024 congress. The trial evaluates eftilagimod alpha (efti) combined with MSD's KEYTRUDA in patients with recurrent or metastatic head and neck squamous cell carcinoma with PD-L1 expression below 1. The new data shows significant improvements in overall survival, progression-free survival, and durability when compared to historical anti-PD-1 therapy results. The findings suggest a potential breakthrough for an underserved patient population that currently has limited treatment options.

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POSITIVE FACTORS

  • Strong overall survival and progression-free survival data reported.
  • Durability of treatment effects seen in patients with hard-to-treat cancers.
  • High response rates build confidence in the novel treatment approach.
  • Positive commentary from clinical investigators supports the findings.

Full Press Release Details

Immutep Reports Promising New Data in Head and Neck Cancer
at ESMO Immuno-Oncology 2024
SYDNEY, AUSTRALIA 12 December 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ( Immutep or
the Company ), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces positive clinical results from Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. This study evaluates eftilagimod alpha (efti) in combination with MSD s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) in first line recurrent/metastatic head and neck squamous cell carcinoma
(1L HNSCC) patients with negative PD-L1 expression.
The new promising data presented by Martin Forster, M.D.,
Ph.D., at the ESMO Immuno-Oncology (IO) Annual Congress 2024 includes strong overall survival, progression-free survival, and durability. This adds to the high response rates and favourable safety data previously reported on 12 July 2024.
Prof. Martin Forster of the UCL Cancer Institute and University College London Hospital NHS Foundation Trust, London, UK, and TACTI-003 Investigator, stated, The new survival and durability data, coupled with increasing complete responses, build on the strong response rates already established with this novel IO combination in
head and neck squamous cell cancers with PD-L1 CPS <1. This difficult-to-treat disease places a high burden on patients who
unfortunately have very limited treatment options that all include chemotherapy. Collectively, these impressive results build on the potential promise of efti to improve patient outcomes and expand populations that respond to anti-PD-1.
Data as of the 31 October 2024 cut-off date in evaluable 1L HNSCC patients (N=31) whose tumours express PD-L1 below 1 (Combined Positive Score [CPS] <1) and who typically do not respond well to anti-PD-1 therapy alone shows:
This data compares favourably to historical results from
anti-PD-1 therapy alone in 1L HNSCC patients with PD-L1 CPS <1 including a 7.9-month
median OS, 12-month OS rate of 39%, 2.1-month median PFS, 2.6-month median DOR, 5.4% ORR and 32.4% DCR with no complete responses2-3.
Marc Voigt, CEO of Immutep, noted, Despite the significant progress of cancer immunotherapy over the past
decade and the positive change in the therapeutic landscape it has brought to bear, head and neck cancer patients with PD-L1 expression of less than one continue to have limited treatment options that all
include chemotherapy. We believe this data is an encouraging step in the right direction towards potentially bringing a new approach to this underserved population, representing up to 20% of patients with this difficult disease.
PD-L1 CPS <1 is an underserved patient population with limited treatment options. Immutep will continue to follow the maturing data from TACTI-003 and engage with
regulatory authorities regarding potential paths forward.
The ESMO IO poster is available on the Posters & Publications section of
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC,
a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune
disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio
harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information,
please visit www.immutep.com.
Australian Investors/Media:
+61 (0)406 759 268; catherine.strong@sodali.com
Chris Basta, VP, Investor Relations and
Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
This announcement was authorised for release by the Board of Immutep Limited.
Immutep Limited, Level 32, Australia Square, 264 George Street, Sydney NSW 2000, Australia

Frequently Asked Questions

What are the new data results from Immutep?

Immutep reported promising survival and response rates from the TACTI-003 trial.

What is the TACTI-003 trial about?

The TACTI-003 trial studies eftilagimod alpha combined with KEYTRUDA in HNSCC patients.

How does efti benefit PD-L1 CPS <1 patients?

Efti may improve outcomes for HNSCC patients who typically have limited treatment options.

What treatment options exist for PD-L1 CPS <1 patients?

Current options mainly include chemotherapy, which are limited for these patients.

How will Immutep proceed after these results?

Immutep plans to monitor TACTI-003 data and engage with regulatory authorities.

Last updated: Dec 12, 2024