Lyell Immunopharma Receives Regenerative Medicine Advanced Therapy (RMAT) Designation for LYL314 for the Treatment of Relapsed and/or Refractory Large B-Cell Lymphoma

Core Viewpoint - Lyell Immunopharma, Inc. has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for its next-generation CAR T-cell therapy, LYL314, aimed at treating adult patients with relapsed and/or refractory large B-cell lymphoma after two or more prior lines of therapy [1][2][7] Group 1: RMAT Designation and Clinical Data - The RMAT designation provides benefits similar to Fast Track and Breakthrough Therapy designations, facilitating early interactions with the FDA [2][6] - LYL314 is a dual-targeting CD19/CD20 CAR T-cell product candidate designed to enhance complete response rates and prolong response duration compared to existing CD19-targeted therapies [1][8] - Initial data from the Phase 1/2 trial showed a 94% overall response rate (16 out of 17 patients) and a 71% complete response rate by three months, with a median follow-up of 6.3 months [3][4] Group 2: Future Clinical Developments - Additional clinical updates from the Phase 1/2 trial are expected in 2025, including more mature data from patients in the 3rd or later line setting and initial data from the 2nd line setting [4][7] - Two pivotal programs for LYL314 are planned, one for patients in the 3rd or later line setting expected to start in mid-2025 and another for the 2nd line setting anticipated to begin by early 2026 [4][9] Group 3: Company Overview - Lyell Immunopharma is focused on advancing a pipeline of next-generation CAR T-cell therapies for hematologic malignancies and solid tumors, utilizing technologies to enhance CAR T-cell durability and efficacy [10]