Lyell’s lymphoma data for recently acquired CAR-T receive lukewarm reception on Wall Street
Lyell Immunopharma reported an 88% overall response rate (ORR) and a 72% complete response (CR) rate in 25 patients with relapsed/refractory large B cell lymphoma (LBCL) treated with its dual-targeting CD19/CD20 CAR-T candidate, LYL314, in a Phase 1/2 trial. Despite the encouraging preliminary efficacy, investor response was negative, with Lyell’s stock ($LYEL) declining by ~8%.
Analysts questioned the decision to focus exclusively on CAR-T–naïve patients, given the company’s stated aim of competing with existing CD19 CAR-T therapies such as Yescarta (Gilead), Breyanzi (Bristol Myers Squibb), and Kymriah (Novartis).
LYL314, formerly IMPT-314, was acquired in 2023 through Lyell’s $30 million acquisition of ImmPACT Bio. The company has since deprioritized most of its pipeline, including its previous lead candidate, LYL797.
Safety data showed no instances of cytokine release syndrome (CRS) across 51 treated patients. The median follow-up was nine months. Lyell is advancing LYL314 into the pivotal PiNACLE trial (n=120) in third-line LBCL and plans to initiate a second-line trial in early 2026. In an early cohort of 11 second-line patients, 10 responded and six achieved CR.
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