Onco-Summaries: Daily Oncology Updates at a Glance

23/07/2025

Roche's Itovebi regimen received approval in the EU for ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation (Ref)

The European Commission approved Roche's inavolisib (Itovebi; PIK3CA inhibitor) + palbociclib + fulvestrant for the treatment of adult patients with PIK3CA-mutated, ER+ve, HER2-ve, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment

• The approval is based on results from the Phase 3 INAVO120 trial which showed a 57% reduction in the risk of disease worsening or death with the Itovebi regimen vs palbociclib + fulvestrant (mPFS: 15.0 mos vs. 7.3 mos; HR=0.43; 95% CI: 0.32-0.59, p<0.001) in the first-line setting

  
  

• The PFS benefit was consistent across all pre-specified subgroups

  
  

• The combo was well tolerated, with no new safety signals observed

J&J's DARZALEX subcutaneous formulation received approval in the EU for smouldering multiple myeloma (Ref)

The European Commission approved Johnson & Johnson's daratumumab (DARZALEX; anti-CD38) subcutaneous formulation as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma

• The approval is based on results from the Phase 3 AQUILA trial in which patients who received daratumumab SC showed statistically significant improved PFS vs patients who underwent active monitoring (HR=0.49; 95% CI: 0.36-0.67; p<0.001)

  
  

• OS was also extended with daratumumab SC, with 5-year rates of 93.0% vs 86.9% for active monitoring (HR=0.52; 95% CI: 0.27-0.98)

Revolution Medicines' elironrasib received the Breakthrough Therapy Designation from the FDA for KRASm NSCLC (Ref)

The US FDA granted the Breakthrough Therapy Designation to Revolution Medicines' elironrasib (RAS(ON) G12C-selective inhibitor) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor.

• The designation was granted based on results from the Phase 1 RMC-6291-001 trial of elironrasib monotherapy in patients with advanced KRAS G12C solid tumors

  
  

  • Results from the trial demonstrated highly competitive antitumor activity, including differentiated safety and tolerability along with a compelling ORR and PFS

    
    

• Mark A. Goldsmith, CEO and Chairman, Revolution Medicines: “There continues to be a need for new targeted therapies for patients with RAS-addicted cancers, and this Breakthrough Therapy Designation from the FDA highlights the therapeutic potential of elironrasib, a differentiated inhibitor, for patients with KRAS G12C lung cancer. Coming shortly after daraxonrasib was granted a designation for patients with advanced RAS mutant pancreatic cancer, this designation for elironrasib further validates our innovative product engine as a source for novel potential treatment approaches for patients with RAS mutant cancers.”

The first patient has been enrolled in the Phase 3 HARMONi-GI2 trial of ivonescimab combination in pancreatic cancer (Ref)

The first patient has been enrolled in the registration Phase 3 AK112-310/HARMONi-GI2 trial of Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy with or without ligufalimab (anti-CD47) for the first-line treatment of metastatic pancreatic cancer

• Prof. Yu Xianjun, Director, Fudan University Shanghai Cancer Center, Prof. Ying Jie'er, Zhejiang Cancer Hospital, and Prof. Tai Sheng, Harbin Medical University Cancer Hospital are the co-principal investigators of the HARMONi-GI2 trial