Slide 1: Long-term follow up of lifileucel (LN-144) in advanced melanoma
Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior therapies Amod Sarnaik, MD H. Lee Moffitt Cancer Center, Tampa, FL, USA 1 Amod Sarnaik, MD H. Lee Moffitt Cancer Center, Tampa, FL
Slide 2: Presenter Disclosure Information
Presenter Disclosure Information Amod Sarnaik, MD The following relationships exist related to this presentation: • Consulting or Advisory Role: B4CC, Iovance Biotherapeutics • Research Funding: Genentech (Inst); Iovance Biotherapeutics (Inst); Provectus (Inst) • Patents, Royalties, Other Intellectu
Slide 3: Iovance C-144-01: Background
Iovance C-144-01: Background • There are currently no approved agents for patients with metastatic melanoma whose disease progressed after immune checkpoint inhibitors (ICIs) and BRAF/MEK inhibitors • In patients who are either primary refractory or develop resistance to ICI, retreatment with ICIs o
Slide 4: Iovance C-144-01 Study Design
Iovance C-144-01 Study Design Phase 2, multicenter study to assess the efficacy and safety of autologous Tumor Infiltrating Lymphocytes (lifileucel) for treatment of patients with metastatic melanoma (NCT02360579) Cohort 1: Cohort 2 Endpoints: Patient Non-cryopreserved • Primary: Efficacy defined as
Slide 5: C-144-01 Cohort 2 Patient Characteristics
C-144-01 Cohort 2 Patient Characteristics CHARACTERISTIC Cohort 2, N=66, (%) CHARACTERISTIC Cohort 2, N=66, (%) Gender, n (%) BRAF Status, n (%) Female 27 (41) Mutated V600 17 (26) Male 39 (59) Wild Type 45 (68) Age, years Unknown 3 (5) Median 55 Other 1 (2) Min, Max 20, 79 Baseline LDH (U/L) Prior
Slide 6: Study Overview and Procedures
Study Overview and Procedures 1 2 3 4 5 6 Patient Intake Surgical Resection NMA-LD TIL Infusion IL-2 Infusions Recovery/Discharge The process begins with surgical Patient undergoes Patient receives one time Following lifileucel, patients resection of a tumor lesion (~1.5 cm in nonmyeloablative treat
Slide 7: Iovance C-144-01 Cohort 2 Safety
Iovance C-144-01 Cohort 2 Safety: Treatment Emergent Adverse Events (≥ 30%) Cohort 2 (N=66) PREFERRED TERM Any Grade, n (%) Grade 3/4, n (%) Grade 5, n (%) Number of patients reporting at least one Treatment-Emergent AE 66 (100) 64 (97.0) 2 (3.0)* Thrombocytopenia 59 (89.4) 54 (81.8) 0 Chills 53 (80
Slide 8: C-144-01 Cohort 2 Safety: Adverse Events over Time
C-144-01 Cohort 2 Safety: Adverse Events over Time • The adverse event profile was consistent with the underlying advanced disease and the safety profile of the lymphodepletion and IL-2 regimens • Median number of IL-2 doses administered was 6 • Decreasing frequency of AEs over time is reflective of
Slide 9: C-144-01 Cohort 2 Efficacy
C-144-01 Cohort 2 Efficacy PATIENTS, N=66 RESPONSE n (%) Objective Response Rate 24 (36.4) • After a median study follow-up of 18.7 months, median DOR was still not reached Complete Response 2 (3.0) (range 2.2, 26.9+) Partial Response 22 (33.3) • Response was seen regardless of location of tumor res
Slide 10: C-144-01 Cohort 2 ORR By Subgroup
C-144-01 Cohort 2 ORR By Subgroup Responses were demonstrated: • Across a wide age range • Even in patients who have progressed on prior anti-CTLA-4 or prior BRAF • Regardless of the BRAF mutational status • Equally in patients with PD-L1 low or high levels CI, Confidence interval. 95% CI is calcula
Slide 11: C-144-01 Cohort 2 ORR By Subgroup
C-144-01 Cohort 2 ORR By Subgroup Responses were demonstrated: • In patients with elevated LDH (1-2x) • In patients with bulky disease at baseline • Patients with lesions in liver and/or brain • Patients post anti-PD-1 regardless of duration of time from the patient’s last anti-PD-1/L1 ULN, Upper Li
Slide 12: C-144-01 Cohort 2 Efficacy: Best Overall Response
C-144-01 Cohort 2 Efficacy: Best Overall Response 81% (50/62) of patients had a reduction in tumor burden Three subjects had no post TIL disease assessment due to early death, and one due to start of new anti-cancer therapy. 12 Amod Sarnaik, MD H. Lee Moffitt Cancer Center, Tampa, FL, USA
Slide 13: C-144-01 Cohort 2 Efficacy: Time to Response
C-144-01 Cohort 2 Efficacy: Time to Response for Evaluable Patients (PR or Better) 79% of responders had received prior ipilimumab Responses deepen over time (1) BOR is best overall response on prior anti-PD-1 immunotherapy (2) U: unknown (3) Patient 22 BOR is PR 13 Amod Sarnaik, MD H. Lee Moffitt C
Slide 14: C-144-01 Cohort 2: Conclusions
C-144-01 Cohort 2: Conclusions • In heavily pretreated metastatic melanoma patients with high baseline disease burden who progressed on multiple prior therapies, including anti-PD-1 and BRAF/MEK inhibitors, if BRAFV600 mutant, lifileucel treatment results in: • 36.4% ORR • 80.3% DCR • Median DOR was
Slide 15: Acknowledgments
Acknowledgments • The authors would like to thank the patients and their families for participation in the study • The authors would also like to acknowledge the support and dedication of all site team members from all the clinical trial institutions • The authors would like to acknowledge the Iovan