Onco-Summaries: Daily Oncology Updates at a Glance

12/09/2025

The NDA for Alphamab Oncology and CSPC Pharma's anbenitamab + chemo has been accepted by the NMPA for HER2 +ve GC/GEJC (Ref)

China's National Medical Products Administration accepted the NDA for Alphamab Oncology and CSPC Pharma's anbenitamab injection (KN026; anti-HER2 BsAb) in combination with chemotherapy for the treatment of HER2 +ve, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer who have failed at least one prior systemic therapy (which must include trastuzumab in combination with chemotherapy).

• The NDA is based on results from the pivotal Phase II/III KN026-001 trial in which the combo significantly improved PFS and OS

In the Asia cohort of the Phase III MARIPOSA trial, amivantamab + lazertinib improved OS vs osimertinib in EGFRm NSCLC (Ref)

Johnson & Johnson announced positive topline results for OS from the Asia cohort of the Phase III MARIPOSA trial of amivantamab (EGFR x MET BsAb) + lazertinib (tyrosine kinase inhibitor) as a first-line therapy for patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations.

• The combo met the final pre-specified secondary endpoint of OS and showed a clinically meaningful and statistically significant benefit vs osimertinib mono

  
  

• mOS improvement is projected to be >4 years, surpassing osimertinib mono by more than one year