Ensartinib monotherapy (eXalt3) — ALK+ NSCLC, 1L metastatic
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Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Components | DRUG-ENSARTINIB |
|---|
| ID | REG-ENSARTINIB-ALK-1L-NSCLC |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-ESMO-NSCLC-METASTATIC-2024 SRC-NCCN-NSCLC-2025 |
Notes
eXalt3 (phase III, n=290): ensartinib vs crizotinib in 1L ALK-TKI-naive ALK+ advanced NSCLC. mPFS 25.8 vs 12.7 mo (HR 0.51), CNS ORR 64 vs 21% in patients with baseline brain mets. Distinguishing AE profile: rash + pruritus dominate (67% all-grade rash; ~12% Grade ≥3) vs alectinib's myalgia/hepatic profile or brigatinib's early pulmonary events. Single daily dose convenient. Choice within ALK 1L: alectinib (ALEX) remains the cross-trial reference for OS + tolerability; brigatinib (ALTA-1L) preferred for high CNS burden; ensartinib is a viable alternative when access / tolerability dictate, but generally not preferred over alectinib/brigatinib/lorlatinib (CROWN) where available. Lorlatinib (CROWN) shows the deepest 1L PFS but with neurocognitive trade-offs.
Used By
Indication
IND-NSCLC-ALK-1L-ENSARTINIB- IND-NSCLC-ALK-1L-ENSARTINIB