LYL273 (GCC19CART)

Nov. 12, 2025: Lyell Immunopharma, Inc. (NASDAQ: LYEL) reported Q3 2025 results and highlighted multiple CAR T catalysts.

Ronde-cel (rondecabtagene autoleucel/LYL314) – relapsed/refractory large B-cell lymphoma (LBCL): FDA granted RMAT designation in Nov. 2025 for ronde-cel in the second-line (2L) setting, complementing an earlier RMAT in the third-line-plus (3L+) setting (April 2025) and existing Fast Track in 3L+ diffuse LBCL. The pivotal single-arm PiNACLE trial (3L+) is ongoing (100×10^6 CAR T cells; ~120 patients; primary endpoint ORR with duration of response). Updated PiNACLE data are slated for presentation at the ASH 67th Annual Meeting (Dec. 2025), and the company expects these data to support a BLA submission in 2027 (3L+). Lyell initiated PiNACLE–H2H, a Phase 3 randomized 2L head-to-head trial vs liso-cel or axi-cel (primary endpoint event-free survival; ~400 patients); first patient expected by early 2026. Two ronde-cel Phase 1/2 abstracts (clinical/translational) were accepted for oral presentation at ASH 2025.

LYL273 – refractory metastatic colorectal cancer (mCRC): Lyell acquired exclusive global rights (excluding mainland China, Hong Kong, Macau, Taiwan). In an ongoing U.S. Phase 1 trial, ORR was 50% (6/12) across doses; at Dose Level 2, confirmed ORR 67% (including one pathological complete response) and DCR 83%, median PFS 7.8 months. Safety at Dose Level 2 included CRS 83% (Grade 1–2), diarrhea 83% (up to Grade 3), ICANS 33% (Grades 2–3); one DLT with Grade 3 diarrhea/Grade 4 enterocolitis and death from fungal sepsis 48 days post-infusion. Trial continues to determine RP2D; next data update expected 1H 2026. LYL273 has FDA Fast Track for mCRC.

Other: First IND for an undisclosed fully-armed solid tumor CAR T candidate expected in 2026. Cash was ~$320M at Sept. 30, 2025; runway expected into 2027.