Full Press Release Details
Immutep s Efti in Combination with KEYTRUDA Generates Excellent Overall
Survival Benefit in Patients with Metastatic Non-Small Cell Lung Cancer
SYDNEY, AUSTRALIA 23 October 2023 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
excellent new clinical data from the TACTI-002 / KEYNOTE-798 Phase II trial evaluating eftilagimod alpha ( efti ), a soluble
LAG-3 protein and first-in-class MHC Class II agonist, in combination with MSD s (Merck & Co., Inc., Rahway,
NJ., USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first-line treatment for patients with previously
untreated unresectable or metastatic non-small cell lung cancer (NSCLC).
The updated TACTI-002 data, with a cut-off date of August 15, 2023 and a median follow up of over 2 years (25.1 months), was presented by Dr. Enric Carcereny, Catalan Institute
of Oncology (ICO), Badalona, Spain, during a Mini Oral session (#1312MO) at ESMO Congress 2023 on Saturday, October 21st. Key takeaways from the oral presentation detailing results from efti in combination with KEYTRUDA for frontline treatment of advanced or metastatic NSCLC in the TACTI-002 Phase II trial1 include:
Table 1: Overall Survival of Efti +
KEYTRUDA versus standard-of-care IO, IO-IO, IO-chemo, and IO-IO-chemo therapies for first-line treatment of advanced non-small cell lung
cancer patients with PD-L1 TPS 1%
* NSQ = Non-squamous; SQ =
In NSCLC patients with >1% PD-L1 expression, a key area for efti s future
development where it has FDA Fast Track status, the ORR (48.3%), mPFS (11.2 months), mDOR (24.2 months), and mOS (35.5 months) compare overall favourably to historical results of
anti-PD-1 monotherapy, as well as to historical results of approved anti-PD-1 +
chemo-containing regimens. Collectively, the breadth of efficacy and safety data from the large number of metastatic NSCLC patients in the Phase II TACTI-002 trial offers compelling evidence of efti s
substantial impact in safely stimulating the patients immune response to fight cancer.
Dr. Enric Carcereny stated, The strong efficacy
data across all levels of PD-L1 expression in TACTI-002, especially in PD-L1 low (1-49%)
and PD-L1 negative (<1%) patients, differentiates efti in combination with anti-PD-1 from other chemo-free immuno-oncology
combinations in the frontline treatment of advanced or metastatic non-small cell lung cancer. Unlike other IO-IO combinations that only work in high PD-L1 expressing patients or IO-chemo combinations that rely on toxic chemotherapy to drive better efficacy, efti is clearly enabling deep, durable responses for patients
regardless of PD-L1 expression with a favourable safety profile that s in line with anti-PD-1 monotherapy.
Marc Voigt, Immutep CEO stated, We are extremely pleased to report these excellent overall survival results, the gold standard benchmark within
oncology, in patients with metastatic non-small cell lung cancer, and believe these are among the strongest ever delivered in a sizable Phase II clinical trial like
TACTI-002 evaluating a dual immuno-oncology approach. The strength of the data positions us well as we continue to plan and prepare for our Phase III trial that we expect to launch next year.
Conference Call and Webcast Details
Immutep will host a conference call and webcast to discuss the clinical data presented at ESMO 2023 and provide an overview on future clinical development
plans for efti in 1st line non-small cell lung cancer. The event will feature CEO Marc Voigt, CSO Dr Frederic Triebel, CMO Dr Florian Vogl, and Christian Mueller, Senior Vice President Strategic Development.
An open question & answer session with all presenters will conclude the event. A replay of the webcast will be available under the Events section of Immutep s website.
Lung cancer is the second most common cancer. Non-small cell lung cancer accounts for
approximately 80-85% of all lung cancers, impacting an estimated 1.87 million people annually, and is the highest cause of death among all cancers4-6.
KEYTRUDA is a registered trademark of Merck
Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Eftilagimod Alpha (Efti)
Efti is Immutep s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and
adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex)
Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN- and CXCL10 that further boost the immune system s ability to fight cancer.
Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck
squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy
and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).
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; cstrong@citadelmagnus.com
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
Clinical data according to iRECIST. Comparable results by RECIST1.1.
2) Arrow lengths in Table 1 are proportional representations of OS data. Data
for standard-of-care therapies taken from publications of respective registrational trials (e.g., KN-042, KN-189, KN-407, CM-227, CM-9LA), and comparison of data is from different clinical trials.
3) Ipi+ Nivo approved in US for 1L NSCLC PD-L1 TPS >1% but not in EU; Pembro monotherapy not
approved in Europe for TPS 1-49%.
4) The Global Cancer Observatory, Lung Cancer Fact Sheet
5) American Cancer Society, About Lung Cancer
6) CDC, Lung Cancer Statistics
announcement was authorised for release by the Board of Immutep Limited.
Immutep Limited, Level 33, Australia Square, 264
George Street, Sydney NSW 2000, Australia