THEORY

Does NCT05608291 meet its primary endpoint at primary completion?

Fianlimab · Melanoma · Phase 3

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Trial

NCT
NCT05608291
Drug / intervention
Fianlimab
Indication
Melanoma
Phase
3
Sponsor
Regeneron Pharmaceuticals
Primary completion
2028-05-16
Status
open

Theories (1)

60% likely to miss · raimo

target LAG-3 · moa checkpoint-inhibition · failure mode target-redundant

  1. premise fianlimab adds LAG-3 blockade to a PD-1 backbone (cemiplimab) vs pembrolizumab in adjuvant resected melanoma
  2. premise counter-evidence: RELATIVITY-047 showed LAG-3 (relatlimab) DID add PFS benefit on a PD-1 backbone in 1L melanoma, so LAG-3 is not cleanly redundant in this substrate resolved_trial:NCT03470922
  3. inference redundancy is plausible but the melanoma precedent argues against a confident fail; the call is near coin-flip with a slight lean to not-met given the high adjuvant RFS bar
  4. prediction RFS superiority over pembrolizumab is uncertain (p_met ~0.40)

Evidence: resolved_trial:NCT03470922

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