Slide 1: Number of IL-2 Doses and Clinical Outcomes of TIL Cell Therapy: Post Hoc Analysis of C-144-01
NUMBER OF IL-2 DOSES AND CLINICAL OUTCOMES OF TUMOR-INFILTRATING LYMPHOCYTE (TIL) CELL THERAPY: POST HOC ANALYSIS OF THE C-144-01 TRIAL OF LIFILEUCEL IN PATIENTS WITH ADVANCED MELANOMA Jessica C. Hassel,1 Amod Sarnaik,2 Jason Chesney,3 Theresa Medina,4 Omid Hamid,5 Sajeve Thomas,6 Martin Wermke,7 Ev
Slide 2: Declaration of Interests
DECLARATION OF INTERESTS Jessica C. Hassel Honoraria: Almirall, Amgen, Bristol Myers Squibb, GSK, MSD, Novartis, Pierre Fabre, Roche, Sanofi, and Sun Pharma Consulting or advisory role: GSK, MSD, Pierre Fabre, and Sun Pharma Research funding: Bristol Myers Squibb, Sun Pharma, and Sanofi Travel, acco
Slide 3: Background
BACKGROUND • High-dose aldesleukin (IL-2) is approved as monotherapy in metastatic melanoma • Its activity is mediated through endogenous T cell activation; however, IL-2 monotherapy shows limited efficacy and considerable toxicity1,2 • Lifileucel, a polyclonal one-time investigational TIL cell ther
Slide 4: Methods (C-144-01 Trial)
METHODS (C-144-01 TRIAL) 22-day GMP EOA Assessment period: Day 0 to EOA manufacturing NMA-LD Enrollment/ Lifileucel IL-2 Efficacy Long-term Surgical Resection Day -7 to Day -6: CY Follow-up Follow-up Screening Day 0 Day 0 to Day 4 Day -5 to Day -1: FLU EOT Progression or EOS Data cutoff: July 15, 20
Slide 5: Patient Demographics and Baseline Characteristics
PATIENT DEMOGRAPHICS AND BASELINE CHARACTERISTICS Characteristic Full Analysis Set* (N=153) Median age, years (range) 56.0 (20, 79) Sex, n (%) Male 83 (54.2) Female 70 (45.8) • Median number of IL-2 doses Median target lesion SOD (range), mm 97.8 (13.5, 552.9) >3 baseline target and nontarget lesion
Slide 6: Lifileucel ORR and DOR Were Independent of Number of IL-2 Doses
LIFILEUCEL ORR AND DOR WERE INDEPENDENT OF NUMBER OF IL-2 DOSES ORR, by Number of IL-2 Doses DOR, by Number of IL-2 Doses 37.5% 40% (95% CI:15.2, 64.6) Median DOR, DOR ≥12 months, by 31.4% 30.8% 31.2% (95% CI: 24.1, 39.4) months number of IL-2 (95% CI: 14.3, 51.8) (95% CI: 22.7, 40.8) 30% (95% CI) d
Slide 7: Safety Was Independent of Number of IL-2 Doses
SAFETY WAS INDEPENDENT OF NUMBER OF IL-2 DOSES Expected Non-Hematologic IL-2 Toxicities1 in ≥10% of Patients in Any Subgroup, by Number of IL-2 Doses*† Grade 3/4 Lab Hematologic Abnormalities, by Number of IL-2 Doses* 1–2 IL-2 Doses 3–4 IL-2 Doses 5–6 IL-2 Doses Preferred Term, 1–2 IL-2 Doses 3–4 IL
Slide 8: TCR Clonality Was Independent of Number of IL-2 Doses
TCR CLONALITY WAS INDEPENDENT OF NUMBER OF IL-2 DOSES Clonality • Polyclonality* was similar between IL-2 dose groups within each sample type Number of 6 13 57 16 24 109 12 20 93 12 19 88 samples *As measured by the Simpson Clonality Index, which reflects the mono- or poly-clonality of a sample. Val
Slide 9: TCR Clonal Expansion and Persistence Were Observed in All IL-2 Dose Groups
TCR CLONAL EXPANSION AND PERSISTENCE WERE OBSERVED IN ALL IL-2 DOSE GROUPS • uCDR3 clonotypes identified in both tumor and TIL infusion product likely reflect tumor-associated clonotypes captured in the TIL infusion product • These shared uCDR3 clonotypes expanded and persisted to a similar degree,
Slide 10: Conclusions
CONCLUSIONS • Up to 6 doses of aldesleukin were planned in the lifileucel regimen with discontinuation recommended for IL-2 side effects • The median number of IL-2 doses tolerated was 6 • Median cumulative dose administered was 79% lower than the approved maximum cumulative dose of 1 full treatment
Slide 11: European Society for Medical Oncology (ESMO)
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