Onco-Summaries: Daily Oncology Updates at a Glance

24/06/2025

Opdivo + Yervoy received supplemental approval in Japan to expand the use for unresectable hepatocellular carcinoma (Ref)

• Ono Pharmaceutical and Bristol-Myers Squibb K.K. have received a supplemental approval of Opdivo (nivolumab; anti-PD-1) + Yervoy (ipilimumab; anti-CTLA-4) in Japan, to expand the use for the treatment of unresectable hepatocellular carcinoma (HCC)

  
  

  • The approval is based on the results from the global Phase 3 CheckMate-9DW trial of nivo + ipi vs investigator’s choice of lenvatinib or sorafenib monotherapy for patients with unresectable HCC who have not received prior systemic anti-cancer therapy

    
    

    • The combo met its primary endpoint of OS [mOS: 23.7 mos vs 20.6 mos; HR=0.79; P=0.0180)

      
      

    • The safety profile was consistent with previously reported data, with no new safety signals identified

Philogen has voluntarily withdrawn its EMA marketing application for Nidlegy as a neoadjuvant treatment for locally advanced resectable melanoma (Ref)

• Philogen announced the decision to voluntarily withdraw the application for marketing authorization to the EMA for Nidlegy (daromun; L19IL2 + L19TNF) as a neoadjuvant treatment of adult patients with locally advanced fully resectable melanoma

  
  

  • The decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls (CMC) and additional clinical data to better characterize the benefit:risk profile. Provision of the CMC and clinical data were unlikely to be completed within the current allowed timeframe

    
    

  • The MAA was submitted in Jun'24 based on the results from the Ph3 PIVOTAL trial in which daromun reduced the risk of relapse or death by 41% vs control arm. The safety profile of daromun was characterized mostly by low-grade, local AEs