Immutep Ltd · ASX:IMM
Immutep — Corporate Update (June 2024)
24 slides from Immutep's corporate update, Jun 26, 2024
Slide 1: TACTI-003 Topline Data Update and TACTI-004 Overview
TACTI-003 Topline Data Update for Patients with Any PD-L1 Expression (Cohort A) & Negative PD-L1 Expression (Cohort B) in 1L HNSCC and Overview of TACTI-004 Pivotal Phase III in 1L NSCLC Global Webcast Presentation – Thursday, June 27th, at 9AM AEST (Wednesday, June 26th, at 7PM ET) Unlocking the po
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: Pioneering LAG-3 Immunotherapy Portfolio
Pioneering LAG-3 Immunotherapy Portfolio LAG-3 Immutep has designed multiple first-in-class Antigen-presenting cells (APC) T Cell therapeutics targeting either MHC Class II molecules on antigen-presenting cells (APC) or LAG-3 on T-cells MHC Class II to fight cancer & autoimmune disease Targeting MHC
Slide 4: Deep LAG-3 Pipeline in Oncology & Autoimmune Diseases
Deep LAG-3 Pipeline in Oncology & Autoimmune Diseases Program Indication Preclinical Phase I Phase II Late Stage# Collaborations Commercial Rights 1L Non-Small Cell Lung Cancer (NSCLC) TACTI-004 | Efti + Pembrolizumab + Chemo a 1L Head & Neck Squamous Cell Carcinoma (HNSCC) TACTI-003 | Efti + Pembro
Slide 5: Differentiated Approach in Oncology
Differentiated Approach in Oncology Efti has complementary action with immune checkpoint inhibitors (ICIs) like anti-PD-(L)1 therapy Activated Dendritic Cell Innate Adaptive Anti-PD-1 Immunity Immunity antibody NK CXCL10 CD8+ Cell T Cell PD-1 APC Efti T Cell CD4+ Monocyte IFN-ƴ T Cell Efti’s unique
Slide 6: Clinical Trials Target Large Addressable Markets
Clinical Trials Target Large Addressable Markets Non-Small Cell Lung Cancer (NSCLC) HR+/HER2-/TNBC Breast Cancer Head & Neck Cancer drug market estimated at drug market estimated at drug market estimated at US$ 24 billion US$ 12 billion US$ 3 billion *Efti has FDA Fast Track designation in 1L NSCLC
Slide 7: TACTI-003 First Line Head & Neck Squamous Cell Carcinoma (1L HNSCC)
TACTI-003 First Line Head & Neck Squamous Cell Carcinoma (1L HNSCC)
Slide 8: Head and Neck Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma Overview: • Head and neck squamous cell carcinoma (HNSCC) encompasses a spectrum of heterogeneous diseases originating in the oral cavity, pharynx, and larynx • HNSCC is a complex disease involving distinct anatomical sites and with varying etiological factors i
Slide 9: Treatment Landscape in 1L HNSCC
Treatment Landscape in 1L HNSCC High unmet need: Recurrent, unresectable, or metastatic disease not amenable to curative RT or surgery • Overall Survival in first line HNSCC is ~12 months PD-L1 expression: PD-L1 positive tumor PD-L1 negative tumor • PD-L1 expression as measured by Combined Proportio
Slide 10: TACTI-003 / KEYNOTE-PNC-34 Trial Overview
TACTI-003 / KEYNOTE-PNC-34 Trial Overview Efti + anti-PD-1 therapy has FDA Fast Track designation in recurrent or metastatic 1L HNSCC Pembrolizumab + Efti Cohort A (i.v. 400 mg q6w; s.c 30mg q2w) Randomization PD-L1 CPS >1 1:1 Pembrolizumab Monotherapy N=138 ORR, PFS, OS, PK, (i.v. 400 mg q6w) bioma
Slide 11: TACTI-003 Baseline Characteristics in Evaluable Patients
TACTI-003 Baseline Characteristics in Evaluable Patients • 149 evaluable patients out of 171 patients enrolled*: ✓ Efti + KEYTRUDA with CPS >1: 58 of 69 (84%) ✓ KEYTRUDA alone with CPS >1: 60 of 68 (88%) ✓ Efti + KEYTRUDA with CPS < 1: 31 of 33 (94%) • Patients recruited irrespective of HPV status &
Slide 12: Prognostic Factors in HNSCC
Prognostic Factors in HNSCC Imbalances in treatment arms (e.g. smoking status, location of primary tumour) favour KEYTRUDA monotherapy arm Good Prognosis Poor Imbalances in TACTI-003 (Cohort A) Younger age Age at onset Older age - None - Female Gender Male Favours KEYTRUDA arm (30.0% female vs 20.7%
Slide 13: Safety
Safety Efti + KEYTRUDA KEYTRUDA alone Safety Parameter (Cohorts A+B) (Cohort A) n (%) n (%) Any TEAE Leading to Discontinuation of Study Treatment 8 (7.8%) 4 (5.9%) Related to Efti and/or Pembrolizumab 6 (5.9%) 3 (4.4%) • No new safety signals • Rate of treatment related discontinuation was low and
Slide 14: Overall Response Rate in Evaluable Patients
Overall Response Rate in Evaluable Patients TACTI-003 primary endpoint is overall response rate (ORR) in evaluable patients, according to RECIST1.1 Efti plus KEYTRUDA achieved a “The strong, consistent response rates, irrespective of whether patients have high, low, or negative PD-L1 expression, is
Slide 15: Randomised Cohort A in Patients with Any PD-L1 Expression
Randomised Cohort A in Patients with Any PD-L1 Expression TACTI-003 Efti + KEYTRUDA KEYTRUDA alone High PD-L1 Expression (CPS >20) 31.0% ORR (N=29) 18.5% ORR (N=27) In CPS >20, efti + KEYTRUDA shows strongest outperformance with 68% relative increase and 12.5% absolute increase. Patients with CPS >2
Slide 16: Results for Patients with Negative PD-L1 (Cohort B)
Results for Patients with Negative PD-L1 (Cohort B) ORR DCR TACTI-003, Cohort B (CPS <1) ✓ Positive preliminary 26.9% ORR and 57.7% disease control rate from 26 evaluable patients with CPS <1 reported in April 2024 26.9% 57.7% ✓ Compares favorably to historical results from KEYTRUDA monotherapy (see
Slide 17: Cohort B – ESMO Plenary Session in July 2024
Cohort B – ESMO • ESMO Virtual Plenaries are monthly presentations of the latest, original scientific data, including “Phase II trials which demonstrate remarkable Plenary Session in therapeutic benefit, scientific insight or progress in an area of unmet need” July 2024 • Updated clinical data from
Slide 18: Summary & Next Steps
Summary & Next Steps Summary • Efti + KEYTRUDA leads to an ORR consistently above 30% across all CPS expression levels (high, low, negative) • In the randomised Cohort A, efti in combination with KEYTRUDA shows the strongest performance in patients with high PD-L1 expression (CPS >20) with a 31.0% O
Slide 19: Lead Indication First Line Non-Small Cell Lung Cancer (NSCLC)
Lead Indication First Line Non-Small Cell Lung Cancer (NSCLC) ASCO 2022 - Dr. Enriqueta Felip presenting 1L NSCLC SITC 2022 - Dr. Wade Iams presenting 1L NSCLC data from ESMO 2023 - Dr. Enric Carcereny presenting Overall data from TACTI-002/KN-798 in Oral Presentation TACTI-002/KN-798 in Late Breaki
Slide 20: Immutep & Merck (MSD) to Undertake Phase III Trial in NSCLC
Immutep & Merck (MSD) to Undertake Phase III Trial in NSCLC Opportunity to set a new standard of care across entire NSCLC population regardless of PD-L1 expression MSD / Immutep Collaboration Key Highlights • Immutep will conduct the registrational • All comer trial: will not select for PD-L1 and in
Slide 21: TACTI-004 Trial Design
TACTI-004 Trial Design Trial Overview: • TACTI-004 will be a 1:1 randomized, double-blind, multinational, controlled clinical study with ~750 patients • Trial will enroll first line squamous and non-squamous NSCLC patients who are unselected for PD-L1 expression • Dual primary endpoints will be Prog
Slide 22: Uniquely Positioned Phase III in 1L NSCLC Landscape
Uniquely Positioned Phase III in 1L NSCLC Landscape • KEYTRUDA has revolutionized the treatment landscape in lung cancer, and as a result MSD (Merck) captures between 7 to 8 of every 10 metastatic lung cancer patients today* High Low Squamous PDL1 PDL1 ~30% ~35% • Of KEYTRUDA’s ~US$ 25 billion in sa
Slide 23: Outlook
Outlook Milestones & Catalysts Ahead • Non-Small Cell Lung Cancer – TACTI-004 preparations for study start with FPI in late 2024 / early 2025 • Head & Neck Squamous Cell Carcinoma – Updated Cohort B data 11th July at ESMO Plenary Session; additional data at medical conference H2 2024 • Non-Small Cel
Slide 24: Thank you
Thank you