Clinical TrialJun 8, 2026, 06:01 AM
Lyell Amends LYL273 Phase 1 Trial for Seamless Phase 2 Expansion
AI Summary
Lyell Immunopharma provided an update on its LYL273 U.S. Phase 1 clinical trial for relapsed or refractory metastatic colorectal cancer, announcing an amendment to enable seamless expansion into a potential pivotal single-arm Phase 2 trial. The company reported a significant reduction in Grade ">=" 2 diarrhea/colitis from 55% to 10% with gastrointestinal prophylaxis, with no Grade ">=" 3 CRS or ICANS in these patients. New cohorts, including a second-line and radiotherapy combination, have been added, and an End-of-Phase 1 FDA meeting is expected in H2 2026.
Key Highlights
- U.S. Phase 1 trial for LYL273 amended for seamless expansion into potential pivotal Phase 2.
- GI prophylaxis reduced Grade ">=" 2 diarrhea/colitis from 55% to 10%.
- No Grade ">=" 3 CRS or ICANS observed in 10 patients with GI prophylaxis.
- New cohorts added to trial, including second-line and radiotherapy combination.
- Up to 60 patients expected to be enrolled across new cohorts.
- Additional Phase 1 data and End-of-Phase 1 FDA meeting expected in H2 2026.
- LYL273 previously showed 50% overall response rate across Dose Levels 1 and 2.
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