Slide 1: Update on New Data in First Line Treatment of Metastatic Non-Small Cell Lung Cancer
Update on New Data in First Line Treatment of Metastatic Non-Small Cell Lung Cancer Presented at ESMO Congress 2023 Global Webcast Presentation - Monday, October 23rd, at 8AM AEDT (Sunday, October 22nd, at 5PM ET) Unlocking the power of the immune system to fight cancer and autoimmune diseases
Slide 2: Forward-Looking Statements
Forward-Looking Statements The purpose of the presentation is to provide an update of the business of Immutep Limited ACN 009 237 889 (ASX:IMM; NASDAQ:IMMP). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarificati
Slide 3: Eftilagimod Alpha (efti): A First-in-Class Soluble LAG-3 Protein and MHC Class II Agonist
Eftilagimod Alpha (efti): A First-in-Class Soluble LAG-3 Protein and MHC Class II Agonist
Slide 4: Deep Pipeline
Deep Pipeline Program Indication Preclinical Phase I Phase II Late Stage* Collaborations Commercial Rights 1L Head & Neck Squamous Cell Carcinoma (HNSCC) TACTI-003 | Efti+Pembrolizumab a Eftilagimod Alpha 1L Non-Small Cell Lung Cancer (NSCLC), TACTI-002 | Efti+Pembrolizumab a Soluble LAG-3 Protein 2
Slide 5: Immutep's Pioneering Immunotherapies
Immutep’s Pioneering Immunotherapies Only company with multiple therapeutic approaches around LAG-3 / MHC Class II interaction Targeting MHC Class II on APCs Targeting LAG-3 on T cells Targeting LAG-3 on T cells with Soluble LAG-3 Protein (Efti) Antigen- with an Antagonist Antibody with Small Molecu
Slide 6: Efti Driving Adaptive & Innate Immune Response
Efti Driving Adaptive & Innate Immune Response Across multiple clinical trials, efti’s activation of APCs (dendritic cells) leads to sustained increase of cytotoxic CD8+ T cells, other anti-tumor cells, as well as Interferon-γ (IFN-γ) & CXCL10 that augment anti-cancer activity Phase I: Efti monother
Slide 7: TACTI-002 Phase II Trial – Part A
TACTI-002 Phase II Trial – Part A Efti + Pembrolizumab Combination in First Line Treatment of Metastatic Non-Small Cell Lung Cancer Data Update from ESMO 2023 Mini Oral Presentation
Slide 8: TACTI-002 / KN-798 Trial Overview and Baseline Characteristics
TACTI-002 / KN-798 Trial Overview and Baseline Characteristics Part A: Large Phase II trial (N=114) in metastatic 1st Line non-small cell lung cancer (1L NSCLC) Trial Design (Part A) • Phase II, open label, Simon’s two stage • Six countries (US, UK, ES, PL, UA, AU) In collaboration with • 18 sites •
Slide 9: Key Efficacy Data in ITT Population
Key Efficacy Data in ITT Population Intent-to-treat (ITT) population (N=114) includes ~75% patients with TPS <50% and ~35% with TPS <1% • Strong response rate of 40.4%1 [95% CI3: 31.3-50.0] in conjunction with high median DoR of 21.6 months2 • Median OS of 20.2 months (with median follow up of 25.1
Slide 10: Excellent Survival Benefit across all PD-L1 Expression Levels
Excellent Survival Benefit across all PD-L1 Expression Levels Strong efficacy with any PD-L1 (TPS>1%) and PD-L1 negative (TPS <1%), low (TPS 1-49%), high (TPS >50%) Promising efficacy with strong Overall Response Rate (ORR), Progression Free Overall Survival by central PD-L11 Survival (PFS), Duratio
Slide 11: Significant 35.5-Month Median OS Reached in TPS >1%
Significant 35.5-Month Median OS Reached in TPS >1% Patients with any PD-L1 expression or TPS >1% represent ~65% of the 1L NSCLC patient population • Significant median OS of 35.5 months1 • 48.3% ORR, median PFS of 11.2 months, and median DoR of 24.2 months • 12-month PFS- and 36-month OS-rate are v
Slide 12: Benchmarking against Pembrolizumab Monotherapy
Benchmarking against Pembrolizumab Monotherapy Robust Overall Survival, Overall Response Rates, and Progression-Free Survival across all PD-L1 levels Efti + Pembrolizumab Pembrolizumab monotherapy NR TPS ≥1% TPS 1-49% and TPS ≥50% • Efficacy increased by 1.5- to 2-fold for all important • In TPS 1-4
Slide 13: Benchmarking Efficacy to Standard-of-Care
Benchmarking Efficacy to Standard-of-Care ORR, PFS, DOR and OS from Efti + Pembro as compared to Standard-of-Care therapies in PD-L1 TPS ≥1% ORR, PFS and DoR of Efti + Pembro translates into substantially better Overall Survival Chemotherapy-Free IO Options IO-Chemotherapy or IO-IO-Chemotherapy Opti
Slide 14: Benchmarking Long-Term Effects
Benchmarking Long-Term Effects Exceptional durability and quality of responses exhibited through OS and PFS rates in PD-L1 TPS ≥1% 12-month PFS rate 3-year OS rate (TPS ≥1%) (TPS ≥1%) • Efti+Pembro has a similar 12-month PFS rate (46.8%) compared to chemo-containing regimens and superior 12-month PF
Slide 15: Benchmarking against Standard-of-Care in 1L NSCLC
Benchmarking against Standard-of-Care in 1L NSCLC Overall survival & safety of efti + pembro vs. IO, IO-chemo, & IO-IO-chemo in patients with PD-L1 TPS ≥1% Differentiated OS from Efti + Pembro that extends well beyond all standard-of-care regimens achieved with a favorable safety profile that is com
Slide 16: INSIGHT-003 Phase I Trial: Efti + Pembrolizumab + Chemotherapy
INSIGHT-003 Phase I Trial: Efti + Pembrolizumab + Chemotherapy Combination in Metastatic Non-Squamous First Line NSCLC Data from ESMO Abstract (Poster will be presented tomorrow)
Slide 17: INSIGHT-003: IO + IO + Chemo Combination Trial
INSIGHT-003: IO + IO + Chemo Combination Trial INSIGHT-003 - Investigator- initiated study focusing on front line non-squamous NSCLC adenocarcinomas Design: • Evaluating triple combination therapy consisting of efti in conjunction with carboplatin/pemetrexed & anti-PD-1 therapy Outlook: • Study focu
Slide 18: Registration strategy in First Line Treatment of Metastatic Non-small Cell Lung Cancer
Registration strategy in First Line Treatment of Metastatic Non-small Cell Lung Cancer Multiple options moving forward for TACTI-004 in 1L NSCLC
Slide 19: First Line Metastatic Non-Small Cell Lung Cancer
First Line Metastatic Non-Small Cell Lung Cancer Significant patient population whose treatment options are limited in durability & tolerability 1L NSCLC1,2 – 1.87 million NSCLC diagnoses per annum – – Most frequent cause of cancer death (18%) – – 1.3 million patients develop metastatic disease & ar
Slide 20: Efti Uniquely Positioned in 1st line Non-Small Cell Lung Cancer
Efti Uniquely Positioned in 1st line Non-Small Cell Lung Cancer Large potential opportunity for efti with both chemo-free IO-IO and IO-IO-chemo combinations 1L NSCLC Patient Population by PD-L1 Tumor Proportion Score (TPS)1 PD-1 expression levels have substantial impact on clinical outcomes for anti
Slide 21: Scenarios for Phase 3 Registration Study
Scenarios for Phase 3 REGISTRATION Study Strength of new data drives multiple options for chemo-free IO-IO combination with efti + anti-PD-1 General aspects Details for current Scenario: PD-L1 TPS ≥1% • Immutep is preparing to conduct a Phase 3 study and has multiple Patients stratified by 1-49% / ≥
Slide 22: Summary
9 is] immutep Summary
Slide 23: 1L NSCLC: Conclusion & Outlook
1L NSCLC: Conclusion & Outlook Conclusion: Outlook: • Excellent overall survival data in first line treatment of metastatic non-small • Multiple development options to capture the entire NSCLC market by cell lung cancer (NSCLC) through combination of efti, our proprietary PD-L1 status through chemo-
Slide 24: Strong Balance Sheet & Significant Milestones Ahead
Strong Balance Sheet & Significant Milestones Ahead Milestones Achieved in 2023: Upcoming Milestones: Strong cash position of A$110.1m as of 30 September 2023 • Data update from INSIGHT-003 PI trial (efti + anti-PD-1 + post A$80m capital raise in June providing cash runway to chemotherapy) in 1L N
Slide 25: Thank you!
: @ immutep Thank you!