Onco-Summaries: Daily Oncology Updates at a Glance

18/07/2025

ImCheck’s ICT01 received the Orphan Drug Designation for Acute Myeloid Leukemia (Ref)

• The US FDA granted the Orphan Drug Designation to ImCheck Therapeutics' ICT01 (anti-BTN3A) for the treatment of acute myeloid leukemia 

  
  

  • Stephan Braun, CMO, ImCheck Therapeutics: "Receiving FDA orphan drug designation for ICT01 is a significant recognition of ICT01’s innovative therapeutic potential to meet the urgent unmet medical needs of AML patients. This important regulatory milestone reinforces our confidence that ICT01 will become the first immunotherapy for AML patients and supports our goal of rapidly advancing ICT01 into pivotal studies based on the unprecedented results observed in the clinic to date."

    
    

  • In the Phase 1/2 EVICTION trial, ICT01 + azacitidine + venetoclax elicited high remission rates and a positive OS signal in newly diagnosed AML patients unfit for intensive chemotherapy, with benefit observed across a broad range of molecular subtypes, in particular those that were typically less responsive to azacitidine + venetoclax

Roche received a CRL for the sBLA for Columvi in DLBCL (Ref)

• The US FDA issued a complete response letter for Roche’s sBLA for glofitamab-gxbm (Columvi; CD20-targeting T-cell-engaging bispecific antibody) + gemcitabine + oxaliplatin for the treatment of R/R DLBCL patients who are not candidates for autologous stem cell transplant

  
  

  • Based on the CRL, the Phase 3 STARGLO data did not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population

    
    

  • STARGLO was also intended as a confirmatory study to convert the accelerated approval of glofitamab in the third-line or later DLBCL in the US to full approval