Immutep Ltd · ASX:IMM
Immutep — European Society for Medical Oncology (ESMO) Congress 2024
15 slides from Immutep's conference presentation, Sep 15, 2024
Slide 1: Primary Results from TACTI-003: Randomized Phase IIb Trial in 1L HNSCC
European Society for Medical Oncology (ESMO) Congress 2024 Proffered Paper Oral Presentation Primary Results from TACTI-003: A Randomized Phase IIb Trial Comparing Eftilagimod Alpha (soluble LAG-3) Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line Recurrent or Metastatic Head and Neck Squa
Slide 2: Declaration of Interests
DECLARATION OF INTERESTS Claus Andrup Kristensen MSD EMEAC HNSCC Advisory Board Travel grants from MSD Denmark and Merck A/S Claus A Kristensen Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
Slide 3: Background
Background • Eftilagimod alpha: a first-in-class soluble LAG-3 fusion protein and MHC Class II agonist that activates antigen presenting cells (APCs), leading to a broad anti-cancer immune response including but not limited to the activation/proliferation of CD8+ T cells. • Pembrolizumab: antibody t
Slide 4: Rationale
Rationale • Efti as an APC activator leads to an increase in activated T cells (CD4/CD8) and stimulates adaptive/innate anti-cancer immunity, augmenting responses when combined with PD-(L)1 antagonists such as pembrolizumab. • Pembrolizumab is standard-of-care for CPS ≥1 in 1st line HNSCC1. • Encour
Slide 5: Study Design TACTI-003 (randomized, open label)
Study Design TACTI-003 (randomized, open label) Patient Population: R/M HNSCC patients eligible to 1 st line therapy with PD-L1 results available1 Primary endpoint: ORR* by RECIST 1.1 (imaging Q9W for 36 wks then Q12W) in evaluable patients. Secondary endpoints: ORR by iRECIST, DoR, TTR, safety, PFS
Slide 6: Primary Analysis TACTI-003
Primary Analysis TACTI-003 Cohort B Cohort A • Results1 from 31 evaluable patients were • 138 patients enrolled in Cohort A (Oct reported in July at ESMO Virtual Plenary 2021–Oct 2023) across 9 countries. with 35.5% ORR by RECIST 1.1 in 1st line • 118 evaluable patients (≥1 post-baseline R/M HNSCC w
Slide 7: Demographics & Baseline Characteristics
Demographics & Baseline Characteristics • Balanced for CPS and ECOG, which were stratification factors. • Imbalances were noted including: • Higher number of p16+/HPV+ (known for good prognosis) and female in the P alone arm. • Primary tumor locations, e.g. lower number of hypopharyngeal cancers (kn
Slide 8: Tumour Response Summary
Tumour Response Summary Best Overall Response E+P P alone (BOR); N (%) N=58 N=60 Complete response 4 (6.9) 3 (5.0) • Numerically higher ORR1 & DCR1 in Partial response 15 (25.9) 13 (21.7) E+P compared to P alone patients with CPS ≥1. Stable disease 23 (39.7) 22 (36.7) • Comparable results by iRECIST
Slide 9: Tumour Response Summary by CPS ≥20
Tumour Response Summary by CPS ≥20 E+P P alone Waterfall plot of responders CPS ≥20 (N=14) BOR by RECIST 1.1, N (%) N=29 N=27 E+P P alone E+P P alone Complete response 2 (6.9) 1 (3.7) Partial response 7 (24.1) 4 (14.8) Stable disease 13 (44.8) 11 (40.7) Progressive disease 7 (24.1) 11 (40.7) ORR 9 (
Slide 10: Tumour Response Summary by CPS 1-19
Tumour Response Summary by CPS 1-19 Waterfall plot of responders CPS 1-19 E+P P alone BOR by RECIST 1.1, % N=29 N=33 E+P E+P P alone Complete response 2 (6.9) 2 (6.1) P alone Partial response 8 (27.6) 9 (27.3) Stable disease 10 (34.5) 11 (33.3) Progressive disease 9 (31.0) 11 (33.3) ORR 10 (34.5) 11
Slide 11: Baseline Disease Characteristics by PD-L1 (CPS)
Baseline Disease Characteristics by PD-L1 (CPS) CPS 1-19 CPS ≥20 Baseline parameter, % E+P P alone E+P P alone N=29 N=33 N=29 N=27 Imbalances by CPS & treatment Age Median age, years 66 (43-80) 68 (38-86) 64 (43-87) 64 (49-85) arm: (range) Sex Female / Male 17.2 / 82.8 18.2 / 81.8 24.1 / 75.9 44.4 /
Slide 12: Exploratory Biomarker Analysis
Exploratory Biomarker Analysis ALC development on study ALC change by BOR • Absolute lymphocyte count Cohort A1 (E+P) Cohort A2 (P alone) Cohort A1 (E+P) Cohort A2 (P alone) (ALC) increase in E+P group on study (left figure). • ALC increased significantly in responders compared to non- responders (P
Slide 13: Safety Overview
Safety Overview Summary5,6 Most frequent (≥5%), related adverse events5,6 E+P P alone E+P P alone Safety parameters, n (%) Preferred term, n (%) N=69 N=68 N=69 N=68 Any TEARs 39 (56.5) 41 (60.3) Hypothyroidism 5 (7.2) 15 (22.1) Any TEARs with Grade ≥3 7 (10.1) 8 (11.8) Fatigue 9 (13.0) 8 (11.8) Any
Slide 14: Conclusions
Conclusions • E+P led to numerically higher ORR of 32.8% vs 26.7% for P alone in patients with CPS ≥1. • Effect was largest (1.7-fold increase) in CPS ≥20, with ORR of 31.0% (E+P) vs 18.5% (P alone). No difference observed in CPS 1-19, with unexpectedly high ORR for P alone (33.3%). • 34.8% ORR (N=8
Slide 15: Thank you to all the participating patients and their families
Thank you to all the participating patients and their families. And thank you to all participating sites: Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark; The Christie NHS Foundation Trust, Manchester, UK; Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain; Ulm Univers
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