- Presentation Includes Data on All 33 CAR T-Naïve Patients Treated with the Alloy™ Manufactured Material and Recaps Data on 12 Large B Cell Lymphoma Patients Treated with Phase 2 Dose Regimen
- Results Indicate an Off-the-Shelf Allogeneic CAR T Can Potentially Deliver Durable Complete Responses Comparable to Autologous CAR T Therapies
- Potentially Pivotal Phase 2 ALPHA2 Trials Ongoing in the U.S.; Sites in Europe, Canada and Australia Expected to Enroll During 2023
SOUTH SAN FRANCISCO, Calif., June 15, 2023 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland presented updated data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A in 33 CAR T naïve patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL) treated with the Alloy™ manufacturing process material across different CAR T dosing and lymphodepletion regimens. Earlier in June, data from the 12 patients, a subset of these 33 CAR T naïve patients, who received regimen being utilized in ongoing Phase 2 trials was presented at American Society of Clinical Oncology (ASCO) Annual Meeting.
“We believe these data provide strong support for the ability of our product candidates to induce durable complete remissions at a rate similar to approved autologous CD19 CAR T therapies,” said Zachary Roberts, M.D., Ph.D., Executive Vice President, Research & Development and Chief Medical Officer. “The design and execution of our Phase 1 ALPHA/ALPHA 2 trials enabled a systematic evaluation of potential Phase 2 treatment regimens. Based on these data, we were able to select an optimal dosing regimen that we believe will be capable of delivering the benefit of CAR T treatment to patients without the lengthy wait time and risk of manufacturing failure associated with autologous CAR T. We have now turned our attention to enrolling our potentially pivotal Phase 2 trials as quickly as possible.”
The updated analysis (data cutoff April 20, 2023) of ALPHA/ALPHA2 examined data from all 33 CAR T-naïve patients with r/r LBCL who were treated with a single infusion or consolidation therapy (two planned infusions) of ALLO-501/501A manufactured using the Alloy™ manufacturing process. Patients received lymphodepletion with fludarabine (30 mg/m2/day x 3 days) and cyclophosphamide (300 mg/m2/day x 3 days) and varying doses of ALLO-647 (from 13 mg/day to 30 mg/day x 3 days).
The median time from enrollment to the start of therapy was three days and 100% of patients received product per specifications. No patients received bridging therapy. The dosing breakdown for the 33 patients included in this data set is as follows:
- 12 patients treated with a single dose of ALLO-501/501A and FCA90 lymphodepletion (Phase 2 regimen; recap of the ASCO 2023 data presentation)
- 6 patients treated with a single dose of ALLO-501/501A and FCA