Onco-Summaries: Daily Oncology Updates at a Glance

14/07/2025

Henlius’ Ph3 trial of HLX22 combo has dosed the first HER2+ GC patient in the US (Ref)

• Shanghai Henlius Biotech announced the dosing of the first patient in the US in Phase 3 HLX22-GC-301 international, multicentre trial of HLX22 (anti-HER2) + trastuzumab + chemotherapy vs trastuzumab + chemotherapy ± pembrolizumab as a first-line Tx for HER2+ve, locally advanced or metastatic gastroesophageal junction cancer and gastric cancer

  
  

  • The primary endpoints of this study are PFS and OS

    
    

  • The study is co-led by Lin Shen, Peking University Cancer Hospital and Jaffer A. Ajani, MD Anderson Cancer Center

Corcept submitted a NDA for relacorilant as a treatment for platinum-resistant Ovarian Cancer (Ref)

• Corcept Therapeutics submitted a NDA to the US FDA for relacorilant (selective cortisol modulator) to treat patients with platinum-resistant ovarian cancer

• The filing is based on positive data from the pivotal Phase 3 ROSELLA and Phase 2 trials in which patients who received relacorilant + nab-paclitaxel experienced improved PFS and OS vs patients who received nab-paclitaxel monotherapy, with no need for biomarker selection

  
  

• Relacorilant was well-tolerated, and consistent with its known safety profile