Lyell memulai uji coba Fase 3 PiNACLE-H2H ronde-cel pada LBCL 2L

Lyell telah mulai memberikan dosis kepada pasien dalam uji coba acak Fase 3 head-to-head pertama dari ronde-cel versus axi-cel atau liso-cel pada limfoma sel B besar lini kedua (PiNACLE-H2H, ~400 pasien). Uji coba pivotal single-arm PiNACLE pada LBCL 3L+ terus mendaftarkan (~120 pasien) dengan data pivotal diharapkan pertengahan 2027 untuk mendukung pengajuan BLA.

Fakta utama

Diajukan: 12 Mar 2026, 20.12
Peristiwa: Perubahan registri uji klinis
Arah: Positif
Perusahaan: LYELLyell Immunopharma
Aset: ronde-cel
Sumber: SEC 8-K
Keyakinan: Bersumber
CR 2L: 61%
CR (3L+): 76%
terbaik atau 2L: 83%
mPFS (3L+): 18 bulan
pendaftaran 2L: ~400
terbaik atau 3Lplus: 93%
pendaftaran 3Lplus: ~120

Kutipan sumber

EX-99.1 2 lyel-20260312x8kexx991.htm EX-99.1 Document Exhibit 99.1 Lyell Immunopharma Reports Q4 and Full Year 2025 Business and Financial Results • Patient dosing has commenced in first-of-its-kind Phase 3 head-to-head CAR T-cell 2L randomized controlled clinical trial (PiNACLE-H2H) in patients with large B-cell lymphoma, and the 3L+ pivotal trial (PiNACLE) evaluating ronde-cel is ongoing • Phase 1 trial is ongoing for LYL273, an enhanced GCC-targeted CAR T-cell candidate for metastatic colorectal cancer; seven new patients treated without dose-limiting toxicity and including dose escalation to Dose Level 3 • Smital Shah was appointed Chief Financial and Business Officer in March 2026 • Second $50 million tranche of $100 million equity private placement closed in March 2026 after achie

SEC 8-K

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Penting

12 Nov 2025

21.12

LYELLyell Immunopharma

Lyell Immunopharma menerima penetapan RMAT untuk ronde-cel (2L LBCL)

Penetapan status FDASEC 8-K