Onco-Summaries: Daily Oncology Updates at a Glance

16/09/2026

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• Daiichi Sankyo Secures Japan Approvals for Enhertu and Datroway in First-Line Breast Cancer

  
  

• OncoC4 Receives US FDA Fast Track Designation for Cesalatamig in NSCLC

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Daiichi Sankyo Secures Japan Approvals for Enhertu and Datroway in First-Line Breast Cancer (Ref)

Daiichi Sankyo announced the approval of two antibody-drug conjugates in Japan, expanding their use into the first-line metastatic breast cancer setting

The approvals include Enhertu (trastuzumab deruxtecan) + pertuzumab for HER2-positive unresectable or recurrent breast cancer and Datroway (datopotamab deruxtecan) for unresectable or recurrent triple-negative breast cancer (TNBC)

• The approval of Enhertu by Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on results from the Phase 3 DESTINY-Breast09 trial

  • In patients with HER2-positive unresectable or recurrent breast cancer, the regimen reduced the risk of disease progression or death by 44% versus standard THP and achieved a median progression-free survival (PFS) of 40.7 months compared with 26.9 months for THP

• The approval of Datroway by Japan’s MHLW is based on results from the Phase 3 TROPION-Breast02 trial

  
  

  • In patients with unresectable or recurrent TNBC who were not candidates for PD-1/PD-L1 inhibitor therapy, Datroway reduced the risk of disease progression or death by 43% versus chemotherapy, improved median PFS to 10.8 months from 5.6 months, and extended median overall survival (OS) to 23.7 months compared with 18.7 months with chemotherapy.

The approvals further expand Daiichi Sankyo's ADC franchise across two major breast cancer subtypes and reinforce the growing role of ADCs in earlier lines of treatment

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OncoC4 Receives US FDA Fast Track Designation for Cesalatamig in NSCLC (Ref)

OncoC4 announced that the US FDA has granted Fast Track Designation to cesalatamig (AI-081), its investigational PD-1/VEGF bispecific antibody, for the treatment of patients with non-small cell lung cancer (NSCLC) whose disease has progressed following PD-(L)1 inhibitor therapy and platinum-based chemotherapy

The designation is supported by encouraging safety and efficacy observations from the ongoing BiPAVE-001 Phase 1/2 trial

OncoC4 plans to advance cesalatamig into registrational Phase 3 studies in PD-(L)1-refractory/resistant NSCLC and potentially additional tumor types

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