Iovance Biotherapeutics, Inc. · NASDAQ:IOVA
Iovance Biotherapeutics — ESMO 2026
18 slides from Iovance Biotherapeutics's conference presentation, Nov 5, 2026
Slide 1: Efficacy and Safety of Lifileucel and Pembrolizumab in ICI-Naïve Advanced Melanoma
Efficacy and Safety of Lifileucel and Pembrolizumab in Patients with Immune Checkpoint Inhibitor-Naïve Advanced Melanoma: Final Results from IOV-COM-202 Study Andrew J.S. Furness, Helen Gogas, Bernard Doger de Speville Uribe, Donald Lawrence, Gino K. In, Sajeve Thomas, Young Ki Hong, Juan Martin-Lib
Slide 2: Declaration of Interest
Declaration of Interest Andrew J.S. Furness: Reports speaking fees from Bristol Myers Squibb, Eisai, Iovance Biotherapeutics, Ipsen, Merck, and Pfizer; support for attending meetings and/or travel from Achilles Therapeutics, Adaptimmune, ESMO, and Iovance Biotherapeutics; advisory board participatio
Slide 3: Advanced Melanoma: Unmet Need for Frontline Treatments That Provide Long-Term Benefit
Advanced Melanoma: Unmet Need for Frontline Treatments That Provide Long-Term Benefit Approximately half of patients who receive frontline combination ICI therapy do not achieve long-term benefit, representing a population in need of new strategies1 Lifileucel was approved as a second-line treat
Slide 4: IOV-COM-202: Phase 2 Multicohort Study of Lifileucel + Pembrolizumab
IOV-COM-202: Phase 2, Multicohort, Multicenter Study of Lifileucel + Pembrolizumab in Patients with Solid Tumors Cohort 1A of IOV-COM-202 (NCT03645928) assesses the efficacy and safety of lifileucel + pembrolizumab in patients with ICI-naïve unresectable or metastatic melanoma • Patients may have re
Slide 5: Baseline Patient and Disease Characteristics
Baseline Patient and Disease Characteristics Characteristics N=27 Characteristics N=27 Median age, y (min, max) 53.0 (18–68) PD-L1 TPS (central labs), n (%) Male sex, n (%) 18 (66.7) <1 6 (22.2) White 27 (100) ≥1 14 (51.9) Melanoma type, n (%) Missing 7 (25.9) Cutaneous 18 (66.6) Median target lesio
Slide 6: Efficacy: 62.5% ORR and CR Rate of 29.2%
Efficacy Lifileucel with Pembrolizumab results in 62.5% ORR and CR rate of 29.2% Best Percentage Change from Baseline in Target Lesion SOD Investigator-Assessed Response (RECIST v1.1) (n=24) a Best Overall Response 20 n=2 Objective Response Rate, n (%) 15 (62.5) PD SD PR CR (95% CI) (40.6, 81.2) 0 D
Slide 7: Efficacy: Durable and Deepening Responses
Efficacy Lifileucel with Pembrolizumab mediates durable and deepening responses Percentage Change from Baseline in Target Lesion SOD Best Response PD SD PR CR 60 40 20 Percent Change 0 -20 -40 -60 -80 -100 BL D42 D84 D126 M6 M9 M12 M15 M18 M21 M24 M27 M30 M33 M36 M39 M42 M45 M48 M51 M54 M57 Visit IO
Slide 8: Efficacy: Durable and Deepening Responses by Subject
Efficacy Lifileucel with Pembrolizumab demonstrates durable and deepening responses 1A-05 mDOR not reacheda 1A-07 1A-06 (min, max: 4.3 mo, 57.7+ mo) 1A-03 1A-17 Median f/u for DORb: 26.9 mo 1A-18 3 of 15 responders completed 5-year 1A-22 Subjects 1A-12 response assessment w/o PD or death 1A-14
Slide 9: Efficacy: Overall Survival
Efficacy Median OS was not reached with median study follow-up of 50.9 months 100 90 80 70 Overall Survival (%) 60 50 40 30 20 10 + Censored Median OS (95% CI): NR (19.2-NR) 0 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60 63 66 69 72 75 78 Time (Months) Since Pembrolizumab Infusion Pati
Slide 10: Efficacy: Progression-Free Survival and PFS2
Efficacy Lifileucel with Pembrolizumab results in median PFS of 19.8 months and median PFS2 of 34.3 months 100 90 80 Progression-free Survival (%) PFS2 suggests feasibility of systemic 70 therapies in later lines with frontline use 60 of lifileucel 50 40 30 20 + Censored 10 Median PFS (95% CI): 19.8
Slide 11: Successful Salvage after Lifileucel + Pembrolizumab
Successful Salvage after Lifileucel + Pembrolizumab 4 Patient examples with 4 different ways to salvage following lifileucel + Pembrolizumab therapy Patient 1 (1A-01) — Retreatment with Lifileucel 1 BOR of PR (DOR 16.8 mos) in initial treatment; retreated with lifileucel, BOR of PR PFS2 77.4+ mos Pa
Slide 12: Safety: Treatment-Emergent Adverse Events in ≥30% of Patients
Safety: Treatment-Emergent Adverse Events in ≥30% of Patientsa Safety of lifileucel with pembrolizumab consistent with disease and safety profiles of study regimen N=27 Preferred Terms, n (%) Any grade Grade 3/4 Thrombocytopenia 24 (88.9) 18 (66.7) Pyrexia 22 (81.5) 4 (14.8) Safety was consistent wi
Slide 13: Longitudinal Analysis of TCR Clones from Infused Lifileucel
Longitudinal analysis of TCR Clones from the Infused Lifileucel Drug Product in the Periphery All Samples Responders Nonresponders N 13 13 12 4 4 9 7 5 8 7 4 4 N 8 8 8 3 3 6 5 3 6 6 4 4 N 5 5 4 1 1 3 2 2 2 1 100% 100% 100% 80% 80% 80% Percentage Repertoire 65% 60% 60% 60% 60% 45% 45% 40% 40% 43 % 40
Slide 14: Putative Tumor-Reactive T Cells Maintained Throughout TIL Manufacturing
Putative Tumor-Reactive T Cells Are Maintained Throughout the TIL Manufacturing Process in Two Patients with Durable Responses D0 Tumor Digest D11 PreREP D22 TIL DP NeoTCR8 gene signature NeoTCR8 TCR Clones NeoTCR8 TCR Clones 6 6 5.0 3 3 2.5 NeoTCR8 T Cell Proportion 1A-17 (PR) umap_2 umap_2 umap_2
Slide 15: Conclusions
Conclusions In this phase 2 trial, a single administration of lifileucel combined with pembrolizumab in patients with ICI-naïve advanced melanoma demonstrated: Efficacy and durability of responses Manageable and expected safety profile ORR was 62.5%; CR rate was 29.2% TEAEs consistent with the u
Slide 16: TILVANCE-301 Global Phase 3 and Confirmatory Trial
TILVANCE-301 Global Phase 3 and Confirmatory Trial Randomized, multicenter study with optional crossover to Iifileucel (NCT05727904) Study Design Arm A: lifileucel plus Dual primary endpoints: ORR & PFS Patient pembrolizumab a Interim analysis on ORR Population Final analysis on PFS Unresectab
Slide 17: Acknowledgments
Acknowledgments The authors thank the patients and their families, as well as the investigators and study site team members, for their participation in the study. This study was sponsored by Iovance Biotherapeutics, Inc. (San Carlos, CA, USA). Medical writing and editorial support was provided by Io
Slide 18: Thank You
Thank You European Society for Medical Oncology (ESMO) Via Ginevra 4, CH-6900 Lugano T. +41 (0)91 973 19 00 esmo@esmo.org esmo.org 18