Lyell Immunopharma (LYEL) “announced initial positive clinical data from the multi-center Phase 1-2 study of IMPT-314 in patients with large B-cell lymphoma that is being presented at the 66th American Society of Hematology Annual Meeting. IMPT-314 is an autologous dual-targeting CD19/CD20 chimeric antigen receptor T-cell product candidate being developed for patients with aggressive B-cell non-Hodgkin lymphoma. As of October 22, 2024 (the data cutoff for the presentation), 23 patients with relapsed or refractory, CAR T-naive large B-cell lymphoma received IMPT-314. The efficacy evaluable population consisted of 17 patients. The overall response rate was 94%, with 71% achieving a CR by three months. The median follow up was 6.3 months and 71% of patients were in response at last follow-up. In the safety evaluable population of 23 patients, no Grade 3+ CRS was reported. Grade 3 ICANS was reported in 13% of patients with a median time to complete ICANS resolution of 5 days, and rapid improvement to Grade 2 or lower with standard therapy. In the efficacy evaluable set, 16 patients were evaluable for pharmacokinetics. IMPT-314 demonstrated robust expansion and peak cell expansion occurred between Days 7 – 28 post IMPT-314 infusion. Additionally, the final drug product contained the desired naive and central memory cell phenotype that has been associated with improved overall survival in other CAR T cell clinical studies.” “The high rate of complete responses with a favorable safety profile support the strong potential of IMPT-314, Lyell’s next-generation dual-targeting CAR T-cell therapy enriched for naive and central memory T cells. This product candidate was designed to maximize durable responses by overcoming heterogeneous CD19 antigen density and antigen escape, enhance CAR T cell persistence, and reduce exhaustion,” said Lynn Seely, CEO. “Based on these strong data, we remain on track to initiate a pivotal trial in 2025 of IMPT-314 in CAR T-naive patients with large B-cell lymphoma in the 3rd-line+ setting and are continuing to evaluate IMPT-314 in the 2nd-line setting in the ongoing Phase 1-2 trial.”
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