Slide 1: Global Webcast Slides for TACTI-002 data presented at ASCO 2022
For personal use only Global Webcast Slides for TACTI-002 data presented at ASCO 2022 Webcast Details Date & Time: 5.00 pm CDT (Chicago) Monday 6 June 2022/ 8.00 am AEST (Sydney) Tuesday 7 June 2022 Speakers: Immutep CEO Marc Voigt, CMO/CSO Dr Frederic Triebel and Christian Mueller, Vice President S
Slide 2: Notice: Forward-Looking Statements
Notice: Forward-Looking Statements For personal use only 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
Slide 3: LAG-3 Overview: A validated immune checkpoint
For personal use only LAG-3 Overview A validated immune checkpoint
Slide 4: LAG-3 Therapeutic Landscape Overview
LAG-3 Therapeutic Landscape Overview Company Program Preclinical Phase I Phase II Phase III Total Trials Patients Eftilagimod Agonist For personal use only 10 4 14 967 Alpha(5) BMS Relatlimab 7 35 4 46 11,295 Merck & Co. Inc. Favezelimab 1 6 1 8 1,572 Regeneron(1) Fianlimab 1 1 1 3 1936 Ieramilimab
Slide 5: Targeting LAG-3 / MHC II: multiple therapeutics in numerous diseases
Targeting LAG-3 / MHC II: Immutep has multiple therapeutics in numerous diseases IMMUNOSTIMULATION IMMUNOSUPPRESSION For personal use only Efti IMP761 APC activator Agonistic mAb APC Partnered with LAG-3 MHC II GSK’781 Partnered with Depleting mAb Ieramilimab T Cell Antagonistic mAb LAG-3 LAG-3 T Ce
Slide 6: Eftilagimod Alpha: Bringing APC Activation into Oncology
For personal use only Eftilagimod Alpha Bringing APC Activation into Oncology eftilagimod alpha ~ efti ~ IMP321
Slide 7: Efti: an Innovative I-O Product Candidate
Efti: an Innovative I-O Product Candidate For personal use only • Efti is a soluble LAG-3 protein targeting a subset of MHC class II molecules on APCs • Potentially synergistic with other therapeutic agents, e.g. Immuno-Oncology (I-O) agents or chemotherapies “PUSHING THE ACCELERATOR ON IMMUNE RESPO
Slide 8: Immutep's Efti Trial Pipeline
Immutep’s Efti Trial Pipeline* For personal use only Commercial Program Preclinical Phase I Phase II Late Stage(5) Market Size(6) Rights Metastatic Breast Cancer (Chemo – IO) AIPAC US$21.7 billion Head and Neck Squamous Cell Carcinoma (IO – IO) (1b) TACTI-003 US$2.2 billion Head and Neck Squamous Ce
Slide 9: Efti + anti-PD-1 Combination in 1st Line NSCLC: TACTI-002
For personal use only Efti + anti-PD-1 Combination in 1 Line NSCLC st Extending the use of Pembro alone and Chemo + Pembro Especially beneficial for PD-L1 low expressors TACTI-002 Interim update from ASCO 2022
Slide 10: TACTI-002 Design & Status
TACTI-002 (Phase II) Design & Status TACTI-002: Two ACTive Immunotherapeutics in NSCLC and HNSCC For personal use only UNSELECTED FOR PD-L1 In collaboration with PART A S 1ST LINE MET. NSCLC C R PART B COMBINED E ORR, PFS, OS, PK, 2ND LINE MET. NSCLC, IMMUNOTHERAPY E PEMBROLIZUMAB + EFTI FOR 12 biom
Slide 11: Part A - Epidemiology, Landscape & Unmet need
TACTI-002 1st line NSCLC (Part A) - Epidemiology, Landscape & Unmet need For personal use only Epidemiology(1),(2): Unmet need: • 1,870,000 NSCLC diagnoses per annum worldwide • Median OS still < 24 months for most patients growing by 1.5% p.a. • Low efficacy of anti-PD-(L)1 monotherapy for patients
Slide 12: Part A - Statistical Considerations
TACTI-002 1st line NSCLC (Part A) - Statistical Considerations 12 For personal use only KEY ASSUMPTIONS STATISTICAL CONSIDERATIONS FINAL SAMPLE SIZE • Design: Simon’s 2-stage design + extension. • “True” ORR1 pembro monotherapy = 23% • For overall group: using the assumption of an ORR of 35% • With
Slide 13: Part A - Baseline Characteristics
TACTI-002 Results(*) 1st line NSCLC (Part A) - Baseline Characteristics • PD-L1 distribution as expected (~70% with PD-L1 TPS < 50% expression) PD-L1 all comer trial For personal use only • 114 1st line NSCLC patients enrolled with expected disease characteristics Baseline parameters Part A (N=114
Slide 14: Part A - Safety and Exposure
TACTI-002 Results(*) 1st line NSCLC (Part A) - Safety and Exposure For personal use only Safety parameter1 n (%) • Median exposure of efti was 23.1 weeks (range 1- 52.4) and 21.8 weeks for pembro (range 0.1-103.3) Any TEAE 113 (99.1) • 5 patients completed 2 years of treatment until data Any Serious
Slide 15: Part A - Safety - Frequent TEAEs
TACTI-002 Results(1) 1st line NSCLC (Part A) - Safety - Frequent TEAEs Frequent TEAEs (incidence ≥ 15%) by PT regardless of Frequency of TEAEs (by PT) with possible immune etiology For personal use only relationship to any study drug regardless of relationship to any study drug Adverse event by Any
Slide 16: Part A - ORR
TACTI-002 Results(1) 1st line NSCLC (Part A) - ORR For personal use only ORR – PD-L1 all comer iRECIST RECIST 1.1 • ORR (iRECIST - primary Response(5) endpoint) of 38.6% in the ITT n (%), N=114 n (%), N=114 • RECIST 1.1 comparable with Complete Response 2 (1.8) 2 (1.8) 37.7% Partial Response 42 (36.
Slide 17: Part A - ORR by PD-L1 status
TACTI-002 Results(*) 1st line NSCLC (Part A) - ORR For personal use only • ORR (iRECIST) by PD-L1 (central only): 28.1% in PD-L1 negative 41.7% in PD-L1 1-49% Favourable ORR in 52.6% in PD-L1 ≥ 50% PD-L1 low and PD-L1 negative tumors 45.5% in PD-L1 ≥ 1% • DCR (iRECIST) with a range of 68.8
Slide 18: Part A - Waterfall & Spider Plot
TACTI-002 Results(*) 1st line NSCLC (Part A) - Waterfall & Spider Plot 100 For personal use only 75 • 2 complete responses and 19.4% of patients with a target lesion decrease ≥ 50% Best % change from baseline 50 25 • 68/103 (66.0%) of patients with a post-baseline 0 assessment had a decrease in targ
Slide 19: Part A - PFS
TACTI-002 Results(*) 1st line NSCLC (Part A) - PFS For personal use only PFS ITT population (N=114)(*) PFS by PD-L1 status (N=108)(*, 1) • Interim median PFS(*) in the ITT (unselected for • Interim median PFS(1) in PD-L1 ≥ 1% was 8.4 PD-L1) was 6.9 (95% CI: 4.4-8.4) months (95% CI: 6.1-14.0) months
Slide 20: Benchmarking against pembro monotherapy
TACTI-002 Results(*) - 1st line NSCLC Benchmarking against pembro monotherapy For personal use only PRIMARY OBJECTIVE REACHED Efti increases ORR in a PD-L1 unselected patient population compared to pembro Most prominent effects in pts with PD-L1low or PD-L1- patients Findings confirmed by PFS
Slide 21: Benchmarking for 1-49% against IO and IO-chemo
TACTI-002 Results(*) - 1st line NSCLC Benchmarking for 1-49% against IO and IO-chemo For personal use only ORR mPFS (TPS 1-49%) (TPS: 1-49%) 60% 10 9.2 9.3 9 median Progression Free Survival (months) 49.2% 50% 50% 8 7.2 41.7% EFTI OFFERS THE CHANCE FOR A CHEMO- Overall Response Rate (%) 7 40% FREE R
Slide 22: Benchmarking against other IO-IO combinations
TACTI-002 Results (*) - 1st line NSCLC Benchmarking against other IO-IO combinations For personal use only Tiragolumab (anti-TIGIT) Others Tiragolumab plus atezolizumab (135 pts), 1st Vibo (a-TIGIT) + Pembro based on Ph1(2): line NSCLC with ≥ 1% PD-L1(1) • all comer (n=39): ORR 26% (28% unconfirmed)
Slide 23: Efti Positioning in the Treatment Landscape
1st line NSCLC(*) Efti Positioning in the Treatment Landscape For personal use only High unmet need: • Median OS still < 24 months for most patients • Low efficacy of anti-PD-(L)1 monotherapy for patients with TPS < 50% (~70% of total population) • Double chemo + anti-PD-(L)1 increased ORR & OS, b
Slide 24: Summary & Conclusion
Summary & Conclusion For personal use only • ORR (iRECIST) of 38.6% (95% CI: 29.6-48.2) in 1st line NSCLC patients (ITT) unselected for PD-L1. • Comparable results acc. to RECIST 1.1 for ORR with 37.7% (95% CI: 28.8-48.3) in the ITT. • Promising ORR compared to historical control (KN-0421). • Respon
Slide 25: Outlook
For personal use only Outlook
Slide 26: 2022 News Flow
2022 News Flow* For personal use only 2022 New clinical data from TACTI-002 in 2nd line NSCLC Validation of LAG-3/MHC-II interaction through FDA’s approval of Opdualag (BMS) presented at ESMO Lung 2022 (30 March - 2 April) New biomarker & multivariate analysis from AIPAC 2022 is a breakthrou
Slide 27: Thank You
For personal use only Thank You