Immutep(IMMP) - 2023 Q4 - Annual Report

Immutep Announces Excellent Overall Survival Benefit in NSCLC Introduction and Key Announcement Immutep announced excellent TACTI-002 Phase II trial data for first-line NSCLC treatment, presented at ESMO 2023 - Immutep announced excellent new clinical data from the TACTI-002 / KEYNOTE-798 Phase II trial[2] - The trial evaluates eftilagimod alpha (efti) in combination with KEYTRUDA® for first-line treatment of metastatic non-small cell lung cancer (NSCLC)[2] - 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 at ESMO Congress 2023[3] TACTI-002 Phase II Trial Results TACTI-002 trial demonstrated excellent overall survival and promising efficacy across all PD-L1 subgroups in NSCLC patients Overall Survival (OS) Data Median Overall Survival (mOS) showed strong results across PD-L1 subgroups, exceeding expectations and comparing favorably to standard-of-care | PD-L1 Expression (TPS) | Median Overall Survival (mOS) | | :--------------------- | :---------------------------- | | >1% | 35.5 months | | 1-49% | 23.4 months | | >50% | Not yet reached | - The 35.5-month mOS in TPS ≥1% compares very favorably to standard-of-care IO, IO-IO, IO-chemo, and IO-IO-chemo therapies[5] Other Efficacy Endpoints and Durability Promising Overall Response Rate (ORR), Progression Free Survival (PFS), and Duration of Response (DOR) were observed across all PD-L1 subgroups, with exceptional durability - Promising Overall Survival, Overall Response Rate, Progression Free Survival, and Duration of Response are visible across all PD-L1 subgroups (TPS <1%, ≥1%, 1-49%, and ≥50%)[4][5] | Efficacy Endpoint (PD-L1 >1%) | Value | | :---------------------------- | :----------- | | Overall Response Rate (ORR) | 48.3% | | Median PFS (mPFS) | 11.2 months | | Median DOR (mDOR) | 24.2 months | | Median OS (mOS) | 35.5 months | | PD-L1 Expression (TPS) | 3-year OS Rate | 12-month PFS Rate | | :--------------------- | :------------- | :---------------- | | >1% | 45.6% | 46.8% | | 1-49% | 31.0% | 42.1% | | >50% | 63.6% | 55.0% | | Entire Population (N=114) | 36% (36-month OS rate) | N/A | Differentiation and Expert Commentary Efti's strong efficacy across all PD-L1 expressions, especially in low and negative patients, differentiates it from other chemo-free immuno-oncology combinations - Efti in combination with anti-PD-1 differentiates from other chemo-free immuno-oncology combinations due to strong efficacy across all levels of PD-L1 expression, especially in PD-L1 low (1-49%) and PD-L1 negative (<1%) patients[8] - Efti enables deep, durable responses for patients regardless of PD-L1 expression with a favourable safety profile in line with anti-PD-1 monotherapy[8] - Immutep plans to launch a Phase III trial next year based on the strength of the data[8] Conference Call and Webcast Details Immutep will host a conference call and webcast to discuss ESMO 2023 clinical data and future clinical development plans for efti in first-line NSCLC - Immutep will host a conference call and webcast to discuss ESMO 2023 clinical data and future clinical development plans for efti in 1st line NSCLC[10] - The event will feature CEO Marc Voigt, CSO Dr Frederic Triebel, CMO Dr Florian Vogl, and SVP Strategic Development Christian Mueller[10] - The webcast will be held on Monday, October 23rd, at 8 AM AEDT (Sunday, October 22nd, at 5 PM ET)[15] About Eftilagimod Alpha (Efti) Eftilagimod Alpha (Efti) is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist, stimulating innate and adaptive immunity for cancer treatment - Efti is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for cancer treatment[12] - It acts as a first-in-class antigen presenting cell (APC) activator, leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes[12] - Efti has received FDA Fast Track Designation in 1st line HNSCC and in 1st line NSCLC[13] About Immutep Immutep is a clinical-stage biotechnology company specializing in novel LAG-3 immunotherapies for cancer and autoimmune diseases - Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease[14] - The company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3)[14] Additional Information and Contacts This section provides background on lung cancer, trademark information for KEYTRUDA®, and contact details for investors and media - Non-small cell lung cancer (NSCLC) 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 cancers[11] - KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC[11] - Contact information is provided for Australian Investors/Media (Catherine Strong) and U.S. Investors/Media (Chris Basta)[15][16]