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Lyell Presents Positive Initial Clinical Data from the Phase 1-2 Clinical Trial of IMPT-314 for the Treatment of B-cell Lymphoma at the 2024 ASH Annual Meeting
Objective response rate (ORR) of 94% and a complete response (CR) rate of 71% demonstrated after IMPT-314 treatment in CAR T-naïve patients with large B-cell
About this update from Lyell Immunopharma, Inc.
[{"type":"text","content":"Objective response rate (ORR) of 94% and a complete response (CR) rate of 71% demonstrated after IMPT-314 treatment in CAR T-naïve patients with large B-cell lymphoma who had received at least 2 prior lines of therapyManageable safety profile with no high-grade cytokine release syndrome (CRS) and low rates of Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS); adverse events were resolved with standard treatment protocolsInitial clinical data are consistent with clinical experience from UCLA trial of CART19/20, a product candidate with the same CAR construct as IMPT-314 that has demonstrated durable responses in a Phase 1 trial of patients with non-Hodgkin lymphoma SOUTH SAN FRANCISCO, Calif., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies, today 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 (ASH) Annual Meeting. IMPT-314 is an autologous dual-targeting CD19/CD20 chimeric antigen receptor (CAR) 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 (R/R), CAR T-naive large B-cell lymphoma received IMPT-314. The efficacy evaluable population consisted of 17 patients. The ORR was 94% (16/17 patients), with 71% (12/17 patients) achieving a CR by three months. The median follow up was 6.3 months (range 1.2 – 12.5 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% (3/23) 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 (median Tmax = 10 days). Additionally, the final drug product contained the desired naïve and central memory cell phenotype (median,...