Iovance Biotherapeutics, Inc. · NASDAQ:IOVA

Iovance Biotherapeutics — SITC 37th Annual Meeting 2022

16 slides from Iovance Biotherapeutics's conference presentation, November 2022

  1. Slide 1: SITC 2022 37th Annual Meeting

    20322 NOVEMBER 8-12 MASSACHUSETTS The Society for Immunot erapy of Cancer 37" Annual Meeting and Pre-Conference Programs , THE “THELEADING CANCER IM UNOTHERAPY AND TUMOR IMMUNOLOGY CONFERENCE cee

  2. Slide 2: Lifileucel TIL Cell Monotherapy in Patients With Advanced Melanoma After Progression on ICI

    Lifileucel TIL Cell Monotherapy in Patients With Advanced Melanoma After Progression on Immune Checkpoint Inhibitors and Targeted Therapy: Pooled Analysis of Consecutive Cohorts (C-144-01 Study) Amod Sarnaik,1 Karl D. Lewis,2 Harriet Kluger,3 Omid Hamid,4 Eric Whitman,5 Sajeve Thomas,6 Martin Wermke

  3. Slide 3: Background

    Background • Treatment options for advanced (unresectable or metastatic) melanoma are limited after non-response or progression on or after ICI and targeted therapy1-5 • Autologous TIL cell therapy recognizes and targets a multitude of patient-specific neoantigens to mediate tumor cell death • Prior

  4. Slide 4: C-144-01 Study Design

    C-144-01 Study Design Phase 2, multicenter study to assess the efficacy and safety of autologous TIL (lifileucel) for treatment of patients with metastatic melanoma (NCT02360579) Cohort 1 Key Endpoints Noncryopreserved TIL • Primary: ORR (IRC-assessed using RECIST v1.1) product (Gen 1) • Patient Sec

  5. Slide 5: Baseline Patient and Disease Characteristics

    Baseline Patient and Disease Characteristics Cohort 2 Cohort 4 Cohort 2+4 Cohort 2 Cohort 4 Cohort 2+4 Characteristic Characteristic (n=66) (n=87) (N=153) (n=66) (n=87) (N=153) Median age (range), Baseline lesions in ≥3 55.0 (20, 79) 58.0 (25, 74) 56.0 (20, 79) 44 (66.7) 65 (74.7) 109 (71.2) years a

  6. Slide 6: Patient Treatment Patterns

    Patient Treatment Patterns 1L 2L ICI monotherapy ICI combination therapy ICI + targeted therapy • Patients were heavily pretreated 3L Cytokine analogs – 17 (11.1%) received only 1 line of prior Targeted therapy therapy Chemotherapy – 125 (81.7%) received anti–CTLA-4 4L Chemotherapy + cytokine analog

  7. Slide 7: Safety

    Safety Non-Hematologic TEAEs in ≥30% of Patients*,† Grade 3/4 Hematologic Lab Abnormalities* Preferred Term, n (%) Any Grade Grade 3/4 Preferred Term, n (%) Grade 3/4 Chills 117 (75.0) 8 (5.1) Grade Pyrexia 81 (51.9) 17 (10.9) Leukopenia 156 (100.0) 1 Febrile neutropenia 65 (41.7) 65 (41.7) Lymphope

  8. Slide 8: Objective Response Rate (IRC-assessed)

    Objective Response Rate (IRC-assessed) Cohort 2 Cohort 4 Cohort 2+4 (n=66) (n=87) (N=153) • IRC-assessed ORR was 31.4% • The concordance rate between ORR, n (%) 23 (34.8) 25 (28.7) 48 (31.4) IRC- and investigator-assessed (95% CI) (23.5, 47.6) (19.5, 39.4) (24.1, 39.4) ORR was 91% Best overall respo

  9. Slide 9: Tumor Burden Reduction and Best Response to Lifileucel

    Tumor Burden Reduction and Best Response to Lifileucel Best Percentage Change From Baseline in Target Lesion SOD (Cohort 2+4) • 79.3% (111/140) of patients had a reduction in tumor burden 13 patients in the Full Analysis Set are not included (best overall responses included NE [n=6], non- CR/non-PD

  10. Slide 10: Univariable and Multivariable Analyses of ORR

    Univariable and Multivariable Analyses of ORR ORR by Patient and Disease Characteristics ORR by Disease and Prior Therapy Characteristics 1. Kluger HM et al. J Immunother Cancer. 2020;8:e000398. 95% CI is calculated using the Clopper-Pearson Exact test. Vertical dotted line represents overall ORR (3

  11. Slide 11: Time to Response, Duration of Response, and Time on Efficacy Assessment

    Time to Response, Duration of Response, and Time on Efficacy Assessment for Confirmed Responders (PR or Better) • Median time from lifileucel infusion to best response was 1.5 months • Responses deepened over time – 7 patients (14.6%) initially assessed as PR were later confirmed CR – 4 patients (8.

  12. Slide 12: Duration of Response

    Duration of Response Cohort 2 Cohort 4 Cohort 2+4 (n=23) (n=25) (N=48) Median DOR*, NR 10.4 NR months 95% CI (NR, NR) (4.1, NR) (8.3, NR) Min, max 1.4+, 54.1+ 1.4+, 34.3+ 1.4+, 54.1+ (months) Median DOR (95% CI): NR (8.3, NR) months • At a median study follow up of 36.5 months, median DOR was not re

  13. Slide 13: Overall Survival

    Overall Survival Cohort 2 Cohort 4 Cohort 2+4 (n=66) (n=87) (N=153) Median OS*, 15.6 12.7 13.9 months 95% CI (11.0, 23.3) (8.3, 17.8) (10.6, 17.8) Median OS (95% CI): 13.9 (10.6, 17.8) months • The median OS was 13.9 months • The 12-month OS rate was 54.0% (95% CI: 45.6%, 61.6%) *Based on Kaplan-Mei

  14. Slide 14: Overall Survival by Response at 6 Weeks After Lifileucel Infusion

    Overall Survival by Response at 6 Weeks After Lifileucel Infusion Median OS* (months), 95% CI by response at 6 weeks1 Responders NR (30.4, NR) Non-responders 10.3 (6.8, 13.1) Log-rank p-value <0.0001 • In a landmark analysis in patients who achieved response at first assessment (6 weeks [~1.5 mo] po

  15. Slide 15: Conclusions

    Conclusions • Lifileucel TIL cell therapy addresses an important unmet need for patients with difficult-to-treat melanoma who lack effective treatment options in the post-ICI setting • In a large population of heavily pretreated patients with advanced melanoma who progressed on or after ICI and targ

  16. Slide 16: Acknowledgments

    Acknowledgments We thank all of the patients and their families who participated in this study C-144-01 Investigators Iovance Contributors • Ana Arance, MD, PhD • Kevin Kim, MD • Jan Christoph Simon, MD • Friedrich Graf Finckenstein • Tobias Arkenau, MD, PhD • John Kirkwood, MD • Ioannis Thomas, MD

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