Onco-Summaries: Daily Oncology Updates at a Glance

16/12/2025

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• Adagene's muzastotug + pembro received the FDA fast track designation for MSS mCRC without current or active liver metastases

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Adagene's muzastotug + pembro received the FDA fast track designation for MSS mCRC without current or active liver metastases (Ref)

The US FDA granted the fast track designation (FTD) to Adagene's muzastotug (ADG126; masked anti-CTLA-4) + pembrolizumab for the treatment of adult patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) without current or active liver metastases.

• The designation is based on results from the Ph1/2 ADG126-P001/NCT05405595 trial of muzastotug + pembro in previously treated MSS mCRC pts

  
  

  • MSS mCRC pts without liver metastasis were treated with muzastotug 10 mg/kg + pembro (N=29) or muzastotug 20 mg/kg + pembro (N=21)

  
  

  • The 10 mg/kg regimen elicited an ORR of 17.2% (all PRs) with mDOR of 6.2 mos and mPFS of 4.8 mos; Gr3 TRAEs were observed in 20.0% pts (no Gr 4/5 events)

  
  

  • The 20 mg/kg regimen elicited an ORR of 28.6% (all PRs) with both mDOR and mPFS not reached; Gr3 TRAEs were observed in 27.0% pts (no Gr 4/5 events)