Onco-Summaries: Daily Oncology Updates at a Glance

30/06/2025

Revolution Medicines and Summit entered into a clinical collaboration to evaluate RAS(ON) inhibitors and ivonescimab combinations in RAS Mutant Tumors (Ref)

• Revolution Medicines and Summit Therapeutics entered into a clinical collaboration to evaluate the safety and efficacy of Revolution Medicines’ daraxonrasib (multi-selective RAS(ON) inhibitor), zoldonrasib (G12D-selective inhibitor) and elironrasib (G12C-selective inhibitor), in combination with Akeso & Summit Therapeutics’ ivonescimab (PD-1 x VEGF BsAb) in multiple solid tumor settings

  
  

  • The collaboration aims to evaluate the combos across three priority indications including RAS mutant NSCLC, pancreatic ductal adenocarcinoma and colorectal cancer

  
  

  • As a part of the agreement, Summit Therapeutics will supply ivonescimab for clinical research and Revolution Medicines will be the study sponsor

  
  

  • Each company will retain commercial rights to their respective assets, and the agreement is mutually non-exclusive

ORPATHYS® + TAGRISSO® has been approved as a second line Tx in China for EGFR+ve NSCLC patients with MET amplification (Ref)

• The China NMPA granted approval for HUTCHMED Limited's NDA for savolitinib (ORPATHYS; MET TKI) + osimertinib (TAGRISSO; EGFR TKI) for the treatment of locally advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after disease progression on EGFR tyrosine kinase inhibitor

  
  

  • The approval was based on data from the Phase 3 SACHI trial of the combo, which met the primary endpoint of PFS in a pre-planned interim analysis

  • The approval also triggered a US$11 million milestone payment from AstraZeneca, which markets both savolitinib and osimertinib in China

Amgen announced positive top-line results from the Phase 3 FORTITUDE-101 trial of bemarituzumab + chemotherapy in GC/GEJC (Ref)

• Amgen's Phase 3 FORTITUDE-101 trial of bemarituzumab (anti-FGFR2) + chemotherapy met its primary endpoint of OS at a pre-specified interim analysis vs placebo + chemotherapy as a first-line Tx of unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive

• Bemarituzumab + chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS

  
  

• The most common TEAEs in the bemarituzumab + chemotherapy arm were reduced visual acuity, punctate keratitis, anaemia, neutropenia, nausea, corneal epithelium defect and dry eye

  
  

• Detailed results from the trial will be presented at a future medical meeting

  
  

• To note, the FORTITUDE-101 trial was conducted with the support of Zai Lab who holds co-development and commercialization rights for bemarituzumab for mainland China, Hong Kong, Macau, and Taiwan