Lyell reports Q2 2026 results, updated ronde-cel and LYL273 data

Lyell Immunopharma reported second quarter 2026 results on August 6, 2026, alongside updates on its two lead CAR T-cell programs.

For rondecabtagene autoleucel (ronde-cel), the company said its PiNACLE pivotal single-arm trial, a seamless expansion of the 3L+ cohort in the Phase 1/2 multi-cohort trial, is ongoing, with additional data expected in the second half of 2026 and pivotal data expected mid-2027, followed by a planned Biologics License Application submission in the second half of 2027. The primary endpoint is overall response rate, including duration of response.¹ Separately, the Phase 3 PiNACLE-H2H trial, comparing ronde-cel to investigator's choice of axicabtagene ciloleucel or lisocabtagene maraleucel in second-line R/R LBCL, continues to enroll patients, with a progress update expected in the second half of 2026; its primary endpoint is event-free survival.¹

At the EHA 2026 Congress in Stockholm, Lyell presented safety data from more than 100 patients with R/R LBCL treated with ronde-cel, showing no Grade 3 or higher CRS events and low rates of Grade 3 or higher ICANS as of a May 5, 2026 data cutoff, along with a 97% manufacturing success rate.¹

For LYL273, its GCC-targeted CAR T candidate for metastatic colorectal cancer, Lyell reported that a gastrointestinal prophylaxis regimen reduced the rate of Grade 2 or higher diarrhea or colitis from 55% to 10%, with no Grade 3 or higher CRS or ICANS in patients who received prophylaxis.¹ Based on this, Lyell amended the ongoing U.S. Phase 1 trial to a Phase 1/2 design, allowing expansion into a potential pivotal single-arm Phase 2 study once a recommended dose is set, pending FDA discussions, and adding new cohorts including a second-line group and a radiotherapy combination arm.¹ An End-of-Phase 1 meeting with the FDA and additional clinical data are expected in the second half of 2026.¹

On financials, Lyell held $228.0 million in cash, cash equivalents and marketable securities as of June 30, 2026, compared to $247.2 million at year-end 2025, which it said should fund operations into the third quarter of 2027.¹ Net loss for the quarter was $44.8 million, versus $42.7 million a year earlier.¹