2025-06-03-Jefferies-ASCO25一线晚期黑色素瘤格局更新_11页_2mb

ASCO25 1L Advanced Melanoma Treatment Updates

Key Studies and Findings:

• Sarilumab (Sari) + Ipi + Nivo + Rela

  • Objective Response Rate (ORR): 63.6% at 24 weeks
  • Safety: 9% discontinued due to toxicity, 12.1% experienced ≥ grade 3/4 irAEs
  • Efficacy: PFS and OS not reached at cutoff

• Higher Dose Nivo + Rela (480mg/480mg)

  • ORR: Higher response rate compared to standard dose (480mg/160mg)
  • Efficacy: Similar median DOR, PFS, and OS
  • Safety: Higher discontinuation rate due to TRAEs (29% vs. 19%)

• Real-world Nivo + Rela vs Nivo + Ipi

  • Survival: Similar OS benefits between groups (indirect comparison)
  • Progression-Free Survival (PFS): Nivo + Rela group showed longer rwPFS vs. Nivo + Ipi (despite worse baseline factors)

• DNV3 + Toripalimab & Chemo

  • ORR: 37% with manageable TRAEs at lower doses (200mg/m² with fewer severe irAEs)

• Oncolytic Virus + Pucotenlimab + Radiotherapy

  • ORR: 29.4%, with high intrahepatic lesion reduction (65.2%)
  • Survival: 60% 1-year, 51.4% 2-year survival rates

Encouragement for IOBT

• Pipeline Highlights: Encouraged by the clinical and commercial prospects of novel cancer vaccines and IOBT's upcoming Phase 3 PFS data (Q3 2025).

Analyst Certification:

• Roger Song, Cha Cha Yang, Liang Cheng, Fiona Jia – All certify independence and responsible for recommendations.

Risk Factors & Recommendations:

• Clinical/Regulatory: Key uncertainties in trial outcomes and approval timelines.
• Commercial: Market competition and reimbursement challenges.
• Analyst Rating: Buy for IO Biotech, reflecting potential for high returns if outcomes meet expectations.

1. [ASCO25] 1L Advanced Melanoma
   • Sari + Ipi + Nivo + Rela: ORR 63.6% with manageable toxicity (34% TRAEs).
   • Nivo + Rela Dose Comparison: Higher dose showed better ORR but more TRAEs.
   • Real-world Nivo + Rela vs Ipi: Similar OS, longer rwPFS for Nivo + Rela.
   • DNV3 Combo: ORR 37% at standard dose; improved at lower dose with reduced toxicity.
   • Oncolytic Virus + Radiotherapy: 29.4% ORR, 60% 1-year survival rate.

Bottom Line: Incremental advancements in 1L melanoma treatment, particularly in combination therapies and novel modalities, support continued confidence in IOBT's outlook and drug pipeline.