Allogene Therapeutics, Inc. · NASDAQ:ALLO
Allogene Therapeutics — ASCO 2025
16 slides from Allogene Therapeutics's conference presentation, June 2025
Slide 1: ALLO-316 in Advanced Clear Cell Renal Cell Carcinoma: Updated Results From the Phase 1 TRAVERSE Study
ALLO-316 in Advanced Clear Cell Renal Cell Carcinoma: Updated Results From the Phase 1 TRAVERSE Study Samer A. Srour1; Jad Chahoud2; Alexandra Drakaki3; Brendan D. Curti4; Geoffrey T. Gibney5; Sumanta Pal6; Lily Tang7; Sara Charmsaz7; Joy Atwell7; Paul B. Robbins7; Chelsea Williams7; Srinivas Ghatta
Slide 2: Key Takeaway Points
Key Takeaway Points A confirmed ORR of 31% was observed after a single dose of ALLO-316, an allogeneic CD70 CAR T product, in patients with heavily-pretreated advanced or metastatic ccRCC, with multiple ongoing responses, including one extending beyond a year after treatment Safety profile was manag
Slide 3: Background
Background • CAR T therapy has revolutionized treatment of hematologic malignancies, but progress has been slow in solid tumors1 • ALLO-316 is an off-the-shelf, HLA-unmatched allogeneic CD70 CAR T product designed to target both CD70+ tumors and alloreactive host T cells • Phase 1a data from the TRA
Slide 4: TRAVERSE: Transition from Phase 1a to Phase 1b
Total patients enrolled (N = 51) TRAVERSE: Transition from Phase 1a to Phase 1b Received at least 1 dose of LD Received ALLO-316 Evaluable for efficacy (n = 46) (n = 50) (n = 46) CD70+ (n = 38) CD70- (n = 5) CD70 unknown (n = 3) Dose level 1 Dose level 2 Dose level 3 Dose level 4 (40×106) (80×106) (
Slide 5: TRAVERSE Phase 1b Study Design (NCT04696731)
TRAVERSE Phase 1b Study Design (NCT04696731) Key Eligibility Criteria Phase 1ba treatment • Aged ≥18 years with advanced or metastatic Day -5 to Day -3 Day 0 Follow up through M60 ccRCC • Disease progression after Standard ALLO-316 Response and safety Lymphodepletion PD-1 axis and VEGF 80×106 CAR+ c
Slide 6: All Patients Had Multiple Treatment-Refractory Advanced or Metastatic ccRCC
All Patients Had Multiple Treatment-Refractory Advanced or Metastatic ccRCC Phase 1b patients received a median of 4 prior lines of therapy: 59% had received 3+ prior TKIs, 41% had received belzutifan, and 32% were quadruple class refractory to inhibition of the CTLA-4, PD-(L)1, TKI, and HIF-2α path
Slide 7: Adverse Event Profile Consistent With Lymphodepletion and an Active CAR T Therapy
Adverse Event Profile Consistent With Lymphodepletion and an Active CAR T Therapy Phase 1b All patients Phase 1b All patients TEAEs ≥20% n = 22a N = 50 AEs of Special n = 22a N = 50 incidence in Phase Interest, n (%) 1b, n (%) Grade All Grade All Grades Grade ≥3 All Grades Grade ≥3 All Grades ≥3 Gra
Slide 8: Confirmed Responses in Patients With High Tumor CD70 Expression
Confirmed Responses in Patients With High Tumor CD70 Expression CD70+a patients All CD70+a patients Phase 1b n = 38 n = 20 ORR (confirmed CR or PR per RECIST v1.1), n/N (%) 5/20 (25) 8/38 (21) CD70+ TPS ≥50% 5/16 (31) 8/31 (26) CD70+ TPS <50% 0/4 (0) 0/7 (0) aIHC-based CD70 expression. CR, complete
Slide 9: Tumor Responses Occur Early and Are Sustained Following a Single Infusion of ALLO-316
Tumor Responses Occur Early and Are Sustained Following a Single Infusion of ALLO-316 Among CD70+ TPS ≥50% patients, 44% (7/16) had >30% reduction in diameter of baseline target lesions 60 60 40 Change in Tumor Size from Baseline, % 40 Best Change from Baseline, % 20 20 0 -20 0 -40 -60 -20 -80 -100
Slide 10: Regression of Contralateral Kidney Metastasis Following a Single Dose of ALLO-316
Regression of Contralateral Kidney Metastasis Following a Single Dose of ALLO-316 Baseline After 1 month PRESENTED BY: Dr. Samer A. Srour
Slide 11: High Response Rate and Ongoing Remissions
High Response Rate and Ongoing Remissions Out of 5 confirmed responders, 4 have an ongoing response; 1 has reached the 1 year mark post–ALLO-316 Prior Therapies Day 28 Month 2 Month 4 Month 6 Month 8 Month 10 Month 12 HIF2α CTLA-4 PD-(L)1/TKI CD70+ TPS ≥50% CD
Slide 12: Marked Tumor Infiltration by ALLO-316 Seen in Paired Tumor/Blood Samples
Marked Tumor Infiltration by ALLO-316 Seen in Paired Tumor/Blood Samples CAR Vector Copy Number (VCN) by PCR CAR T cell chromogenic RNA in situ hybridization • Homing and infiltration of ALLO-316 CAR T cells into tumor was demonstrated by two independent methods: VCN (PCR) and chromogenic RNA in sit
Slide 13: Responders Had Robust Expansion and Persistence of CAR T Cells
Responders Had Robust Expansion and Persistence of CAR T Cells CD70- patient T cells quickly rebounded while CD70+ patient T cells remained low until ALLO-316 CAR T contraction (Dagger® Effect) VCN Over Time by Best Overall Response CD70+ Host T Cells are eliminated by ALLO-316 CD70- Patient T cells
Slide 14: Conclusions
Conclusions • Patients with advanced or metastatic ccRCC have limited options following development of disease resistant to checkpoint blockers, TKIs and HIF-2α inhibitors • A single dose of ALLO-316 demonstrated a 31% confirmed ORR in patients with heavily-pretreated advanced or metastatic ccRCC. 4
Slide 15: Acknowledgments
Acknowledgments • The authors thank the patients and their families, investigators, and site personnel • Medical writing assistance was provided by Jemimah Walker, PhD, and Matthew Grzywacz, PhD, of ApotheCom (Yardley, PA, USA) and was funded by Allogene Therapeutics, Inc. • AlloCAR T and Dagger® ar
Slide 16: Lay Summary
Lay Summary What did this research tell us? • A one-time treatment with healthy donor-derived CD70 CAR T cells, ALLO-316, had a treatable side effect profile and showed that approximately 1 in 3 patients with high CD70 in the tumor had a response to therapy. Responses could be long lived, with 1 pat