Iovance Biotherapeutics, Inc. · NASDAQ:IOVA
Iovance Biotherapeutics — ASCO 2025
10 slides from Iovance Biotherapeutics's conference presentation, Jun 3, 2025
Slide 1: Lifileucel in patients with advanced melanoma: 5-year outcomes of the C-144-01 study
Lifileucel in patients with advanced melanoma: 5-year outcomes of the C-144-01 study Theresa Medina, MD1, Jason A Chesney, MD, PhD2, Harriet M Kluger, MD3, Omid Hamid, MD4, Eric D Whitman, MD5, Mike Cusnir, MD6, Sajeve A Thomas, MD7, Martin Wermke, MD8, Evidio Domingo-Musibay, MD9, Giao Q Phan, MD10
Slide 2: Key Takeaway Points: 5-Year Analysis of the C-144-01 Study
2 Key Takeaway Points: 5-Year Analysis of the C-144-01 Study 1 2 3 One-time lifileucel The incidence of Lifileucel demonstrated therapy resulted in adverse events (AEs) a long-term treatment durable and deepening declined rapidly benefit in patients with responses in patients within 2 weeks after ad
Slide 3: Background
3 Background • Immune checkpoint inhibitors (ICIs) have improved outcomes in patients with metastatic melanoma but many experience disease progression due to primary1-3 or acquired resistance3,4 • Lifileucel is an autologous T-cell immunotherapy approved for advanced melanoma previously treated with
Slide 4: Patient disposition and baseline characteristics
4 Patient disposition and baseline characteristics Pooled cohorts 2 & 4 Characteristics (N=153) • At the November 20, Median age, years (range) 56 (20–79) 2024, data cutoff, the Male, n (%) 83 (54.2) median follow-up was ECOG performance status, n (%) 0, 1 104 (68.0), 49 (32.0) 57.8 months Stage IV
Slide 5: Durable responses were observed with lifileucel
5 Durable responses were observed with lifileucel • The ORR was 31.4% (complete response [CR], 5.9%; partial response [PR], 25.5%), and 79.3% of patients had a reduction in tumor burden • The median duration of IRC-assessed response was 36.5 months (95% CI: 8.3–NR) • 31.3% (15/48) of responders comp
Slide 6: Ongoing and deepening responses were observed
6 Ongoing and deepening responses were observed Percent Change From Baseline in Target Lesion SOD for Confirmed Responders • The longest duration of ongoing 20 Best response PR CR response was 58.7 months • Responses deepened over 0 time 16 patients had stable Change from baseline, % −20 disease t
Slide 7: Favorable overall survival outcomes were observed
7 Favorable overall survival outcomes were observed • The median OS for the total population was 13.9 months; the estimated 5-year OS rate was 19.7% Overall Survival 100 90 80 Overall survival, % 70 60 50 40 30 20 10 0 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60 Time since lifileucel
Slide 8: Adverse events were consistent with known safety profiles of NMA-LD and IL-2 administration
Adverse events were consistent with known 8 safety profiles of NMA-LD and IL-2 administration • The incidence of AEs decreased Prevalence of Laboratory-Assessed Grade 3/4 Cytopenias rapidly within the first 2 weeks after 100 Ly mphopenia lifileucel infusion, and no new or late- 90 Neutropenia onset
Slide 9: Conclusions
9 Conclusions • This final 5-year analysis of the C-144-01 trial is the longest prospective follow-up of lifileucel and of any drug in the 2L+ setting for ICI-resistant melanoma • One-time lifileucel therapy resulted in durable responses and a 5-year OS rate of 19.7% 31.3% of responders completed
Slide 10: An open-access manuscript on the results of this 5-year follow-up is being simultaneously published
10 An open-access manuscript on the results of this 5-year follow-up is being simultaneously published in the Journal of Clinical Oncology and is available now. “Long-Term Efficacy and Safety of Lifileucel Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy in Patients With Advanced Melanoma: A 5-Year