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Tarlatamab — 2L+ extensive-stage SCLC (DeLLphi-301; DLL3 × CD3 BiTE)

Vista determinista de la entidad fuente YAML. La autoridad clínica sigue con los ID de fuente citados y estado de firma del revisor.

Registro de base de conocimiento para la auditoría. Contenido clínico provisional: esto no es una prescripción. Un oncólogo debe verificar fuentes originales, aplicabilidad y estado de revisión.

Fuente YAML: registro completo

Notas

DeLLphi-301 (Ahn et al., NEJM 2023; NCT05060016): open-label multicenter phase 2 trial of tarlatamab (DLL3 × CD3 bispecific T-cell engager) in pretreated extensive-stage SCLC progressing on or after platinum-based chemotherapy. 222 patients randomized 1:1 to 10 mg q2w vs 100 mg q2w. 10 mg q2w cohort (n=99) — confirmed ORR per independent central review 40% (95% CI 29-52); mDoR not reached at 10.6 mo follow-up; mPFS 4.9 mo; mOS 14.3 mo (95% CI 10.8-NE). 100 mg cohort showed similar ORR with higher CRS rate; 10 mg selected as registered dose. CRS any-grade ~50% (mostly cycle 1 D1-D2 fever ± mild hypotension); Grade ≥3 CRS ~1%. ICANS-like neurotoxicity Grade ≥3 ~7%. Step-up dosing (1 mg → 10 mg) + inpatient cycle 1 D1 + D8 monitoring (22+ hr) is mandatory per US prescribing information; mitigates CRS through immune-effector priming. Tocilizumab + corticosteroids first-line for Grade ≥2 CRS / ICANS. FDA accelerated approval May 2024. NCCN-SCLC 2025 category 2A for ES-SCLC 2L+ post-platinum. Confirmatory phase 3 DeLLphi-304 (tarlatamab vs investigator-choice chemotherapy in 2L ES-SCLC) ongoing. Active development: maintenance post-1L chemo-IO (DeLLphi-303); SCLC-transformed NSCLC; neur...

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Indicación

• IND-SCLC-RR-TARLATAMAB - IND-SCLC-RR-TARLATAMAB