Lyell Immunopharma, Inc. has announced the initiation of two pivotal-stage clinical trials for its product candidate LYL314. The trials will focus on patients with large B-cell lymphoma (LBCL) who have relapsed or are refractory to two or more lines of prior therapy. The company plans to submit a Biologics License Application for LYL314 later in 2027, following the expected data from the LYL314 PiNACLE pivotal trial. Additionally, Lyell is set to conduct a Phase 3 randomized controlled trial for LYL314 in the second-line setting for relapsed or refractory LBCL patients. Furthermore, the company intends to begin a clinical trial evaluating a new internally-developed CAR T-cell therapy targeting an undisclosed solid tumor. Results from these trials are anticipated in the future, with a clinical trial data update from LYL314 expected by the end of this year.
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