Dec. 24 at 3:45 PM
$ELTX Here’s my personal summary, in case it helps anyone:
Phase 1
• RFS (single-arm): 16 months in MRD+ patients (historical DFS ~3–4 months) → very strong result.
• Subgroups are not relevant since all patients are in one arm in Phase 2.
• HR: 0.12 (88% lower risk of death).
Even though intra-arm, assuming non-responders ≈ placebo, a true placebo comparison could improve this.
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Phase 2 – where improvement should come from
• Including MRD+ and MRD− patients should increase absolute DFS, but that alone doesn’t mean better efficacy.
• Real improvement drivers:
• Higher response rate: 99% (P2) vs. 84% (P1)
• Greater depth: fold-change x44 vs. x13
• Better immune quality: CD4+/CD8+ activation 85% vs. 71%
• Antigen spreading
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HR outlook
• HR may worsen by including non-responders, but fewer and better-performing non-responders should offset this.
• Control is saline; using historical DFS of 10–14 months, control and non-responders should behave similarly.
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Corrections welcome.
