Instil Bio, Inc. · NASDAQ:TIL
Instil Bio — Technical Presentation (April 2021)
15 slides from Instil Bio's technical presentation, April 2021
Slide 1: Clinical Feasibility and Treatment Outcomes With Unselected Autologous TIL Therapy in Advanced Cutaneous Melanoma
ePoster LB150 Clinical Feasibility and Treatment Outcomes With Unselected Autologous Tumor Infiltrating Lymphocyte Therapy in Patients With Advanced Cutaneous Melanoma Robert E. Hawkins,1-3 Yizhou Jiang,1 Paul C. Lorigan,2 Fiona C. Thistlethwaite,2,3 Manon Pillai,2 Martine Thomas,1 Natalia Kirillova
Slide 2: Background
Background • A minority of patients with advanced melanoma achieve long-term survival with immunotherapy, and those who relapse following ICI and, if BRAF-mutated, BRAF inhibition have limited treatment options • The intrinsic antitumor activity and broad T-cell receptor repertoire of unselected aut
Slide 3: Methods
Methods • This is a retrospective analysis of a single-center experience of TILs for compassionate use treatment of advanced cutaneous melanoma • Unselected autologous TILs derived from digested tumor tissue were manufactured under a MHRA Manufacturing Specials license • Twenty-one patients with adv
Slide 4: Tissue Procurement and Manufacturing
Tissue Procurement and Manufacturing IL-2, interleukin-2; IV, intravenous; REP, rapid expansion protocol; TIL, tumor infiltrating lymphocyte. 4
Slide 5: Patient Selection Guidelines
Patient Selection Guidelines Should Have Should Not Have • Histologically confirmed malignant melanoma with confirmed • Prior allogeneic transplant evidence of progressive metastatic disease • Symptomatic brain metastasis measuring • Satisfactory hematological and biochemical indices ≥10 mm in diame
Slide 6: Treatment Exposure
Treatment Exposure Treatment Exposure All Treated Patients • Between October 2011 and August (N=21) 2019, 21 patients with advanced Received fludarabine 21 (100) cutaneous melanoma were treated lymphodepletion, n (%) • Median duration of follow-up: Received cyclophosphamide 52.2 months 21 (100) lymp
Slide 7: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics Imaging Evaluable Set All Treated Patients (n=15) (N=21) Age (y), median (range) 54 (16 – 68) 45 (16 – 68) Male, n (%) 11 (73) 15 (71) Stage IV, n (%) 15 (100) 21 (100) Disease sites, median (range) 4 (2 – 10) 4 (2 – 10) M1c disease, n (%) 10 (67) 14 (67) M1
Slide 8: Summary of Safety
Summary of Safety TEAEs Post-TIL Infusion ≥15%, n (%) Any Grade • No grade 5 TEAEs were observed (N=21) • 10 patients died ≥90 days after TIL Thrombocytopenia 13 (62) infusion and prior to data cutoff Pyrexia 12 (57) – 4 due to PD Rigors 9 (43) – 1 possibly due to AE caused by subsequent anticancer
Slide 9: Best Overall Response
Best Overall Response Imaging Evaluable Seta All Treated Patientsb Response (n=15) (N=21) Best overall response (CR + PR), n (%) 8 (53) 14 (67) CR 2 (13) 4 (19) PR 6 (40) 10 (48) Stable disease, n (%) 3 (20) 4 (19) Progressive disease, n (%) 4 (27) 3 (14) Disease control rate (CR + PR + SD), n (%) 1
Slide 10: Overall Survival
Overall Survival CR, complete remission; NE, not evaluable; NR, nonresponder; OS, overall survival; PR, partial remission. 10
Slide 11: Depth of Responses in Imaging Evaluable Set (n=14)
Depth of Responses in Imaging Evaluable Set (n=14)a CR, complete remission; PD, progressive disease; PR, partial remission; SD, stable disease. a One patient with a best overall response of PD did not have any posttreatment target lesion measures reported (progression de termined by observation of n
Slide 12: Time to Response and OS in Responding Patients (n=14)
Time to Response and OS in Responding Patients (n=14) • With a median follow-up of 52.2 months, 5/21 (24%) had durable ongoing responses (>30 months post-TIL infusion) • All patients achieving a CR remained alive and disease free as of data cutoff BRAF, B-raf proto-oncogene; CR, complete remission;
Slide 13: Case Study: Successful Treatment of Brain Metastases
Case Study: Successful Treatment of Brain Metastases Patient and • 16-year-old male with BRAF-mutated melanoma Disease • Extensive mediastinal disease and brain metastases Characteristics • Bulky disease (SLD, 103 mm) Prior Treatment • Relapsed/refractory to 3 prior lines of therapy, including ipili
Slide 14: Conclusions
Conclusions • TIL products made from digested tumors demonstrated high overall and CR rates in this retrospective analysis of a compassionate use case series conducted at the Christie Hospital in Manchester, United Kingdom • AEs were consistent with the established safety profile1 of Cy/Flu+TIL+IL-2
Slide 15: Acknowledgments and Disclosures
Acknowledgments and Disclosures • We would like to thank all the staff within The Christie NHS Foundation Trust and The Christie Clinic who worked tirelessly to provide high-quality care to all the patients in this report • Medical writing support was provided by Christopher Waldapfel, PharmD of Ins