Slide 1: Eftilagimod Alpha & Pembrolizumab in First-Line R/M HNSCC: Primary Results from Cohort B of TACTI-003
Eftilagimod Alpha (Soluble LAG-3) & Pembrolizumab in First-Line Recurrent or Metastatic Head & Neck Squamous Cell Carcinoma: Primary Results from Cohort B (CPS <1) of the TACTI-003 Study Phase IIb study of soluble LAG-3 combined with an anti-PD-1 antibody as a first-line therapy in R/M HNSCC Metcalf
Slide 2: Declaration of Interests
DECLARATION OF INTERESTS Robert Metcalf Advisory Board: Ayala, Bayer, Aptus Clinical, PCI Biotech, Oxsonics, Roche, Achilles Therapeutics. Other: BMS, MSD, Sanofi, Merck. Content of this presentation is copyright and responsibility of the author. Robert Metcalf Permission is required for re-use.
Slide 3: Eftilagimod Alpha & Pembrolizumab in First-Line R/M HNSCC: Primary Results from Cohort B of TACTI-003
Eftilagimod Alpha (Soluble LAG-3) & Pembrolizumab in First-Line Recurrent or Metastatic Head & Neck Squamous Cell Carcinoma: Primary Results from Cohort B (CPS <1) of the TACTI-003 Study Phase IIb study of soluble LAG-3 combined with an anti-PD-1 antibody as a first-line therapy in R/M HNSCC Content
Slide 4: Background
BACKGROUND • Eftilagimod alpha: a soluble LAG-3 protein and MHC Class II agonist that leads to an enhanced immune response through activating antigen presenting cells (APCs), leading to the activation/proliferation of CD8 + T cells. • Pembrolizumab: current standard-of-care that antagonizes PD-1 rec
Slide 5: Rationale
RATIONALE • Eftilagimod activates APCs, leading to an increase in activated T cells (CD4/CD8), augmenting responses when combined with PD-(L)1 antagonists such as pembrolizumab. • Encouraging efficacy has been seen in 2nd line HNSCC1 pts (table, left) after failure of 1st line chemotherapy and in 1s
Slide 6: Study Design
STUDY DESIGN TACTI-003: a multicentre, randomized, open-label Phase IIb trial with 2 cohorts: • Cohort A*: CPS ≥1 patients randomized 1:1 to receive eftilagimod plus pembrolizumab or pembrolizumab alone. • Cohort B**: CPS <1 patients treated with eftilagimod and pembrolizumab. CPS: combined positive
Slide 7: Treatment, Assessments & Endpoints
TREATMENT, ASSESSMENTS & ENDPOINTS Treatment: eftilagimod 30 mg s.c. + pembrolizumab IV 400 mg Q6W for max. 2 years. Radiological assessments performed Q9W for 36 weeks, thereafter Q12W and assessed locally by Investigator. Primary endpoint: ORR by RECIST 1.1. Secondary endpoints: ORR by iRECIST, Do
Slide 8: Demographics & Baseline Characteristics
DEMOGRAPHICS & BASELINE CHARACTERISTICS Baseline parameters N=311 Median age, years (range) 64 (23-83) • 33 patients were recruited at 14 sites across 6 countries Female / Male, % 25.8 / 74.2 between Apr 2022-Oct 2023. ECOG 0 / ECOG 1, % 32.3 / 67.7 • 31 patients were evaluable for efficacy per prot
Slide 9: Safety
SAFETY Summary of TEARs (Safety population) Most frequent TEAEs (Safety population) Safety parameters, n (%) N=33 Preferred term (incidence ≥15%), n (%) N=33 Any TEARs 24 (72.7) Fatigue 7 (21.2) Any TEARs with Grade ≥3 5 (15.2) Weight decreased 6 (18.2) Any TEARs Leading to Discontinuation of Study
Slide 10: Tumour Response Summary
TUMOUR RESPONSE SUMMARY RECIST 1.1 iRECIST Best objective response1, n (%) N=31 N=31 Complete response 3 (9.7) 3 (9.7) ◆ ORR1,3 of 35.5% and DCR1,3 of 58.1%, including ~10% complete responses. Partial response 8 (25.8) 9 (29.0) ◆ 10 responses4 were confirmed until Stable disease 7 (22.6) 8 (25.8) da
Slide 11: Change in Tumour Burden by RECIST 1.1
CHANGE IN TUMOUR BURDEN BY RECIST 1.1 ◆ ~60% experienced tumour shrinkage. ◆ 1 patient* with early pseudoprogression, resulting in later durable response (still on treatment >14 mo). 1 unconfirmed responses per RECIST 1.1, Investigator-assessed. Includes one complete response with a best % change of
Slide 12: Tumour Response Dynamics Over Time
TUMOUR RESPONSE DYNAMICS OVER TIME ◆ 71% of patients remain on treatment for at least 4 months. ◆ ~50% remain on treatment >6 months. Each bar represents one patient in the study. The right arrow cap indicates patients who are ongoing. Responses are per RECIST 1.1. * 1 patient with clear pseudoprogr
Slide 13: Conclusions
CONCLUSIONS • Eftilagimod plus pembrolizumab led to a clinically meaningful objective response rate (ORR) of 35.5% (95% CI: 19.2-54.6) in 1st line HNSCC patients with PD-L1 CPS <1. • ORR compares favorably to historical results (5.4% ORR in 2/37 evaluable patients) of anti-PD-1 monotherapy in 1L HNS
Slide 14: 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: The Christie NHS Foundation Trust, Manchester, UK; Ulm University Medical Center, Department of Otorhinolaryngology and Head & Neck Surgery , Germany; Copenhagen University Hospital - Rigshospit