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DualityBio/BioNTech’s ADC Takes on Enhertu In Chemo-Naive HER2-Low Breast Cancer

 
• By Dexter Jie Yan

The Sino-German partnership is betting that the Phase III DYNASTY-Breast02 trial with the HER2-targeting antibody-drug conjugate DB-1303 will produce a rival to AstraZeneca/Daiichi Sankyo’s Enhertu in the US market.

narrowing window of time
time running out for fast-followers of Enhertu to prove themselves in chemo-free HER2-low breast cancer • Source: Shutterstock

The Chinese antibody-drug conjugate specialist Duality Biologics (DualityBio), together with partner BioNTech SE, are racing against a narrowing window of opportunity to exploit the HER2-low breast cancer field, which was first kicked into high gear by Daiichi Sankyo Co., Ltd. and AstraZeneca PLC’s ADC Enhertu (trastuzumab deruxtecan).

Key Takeaways

  • DualityBio and BioNTech will initiate the US-only Phase III DYNASTY-Breast02 of their HER2-targeting ADC DB-1303 in chemotherapy-naive patients with HER2-low and HR-positive breast cancer.

  • In the same setting, the top-line readouts of the DESTINY-Breast06 study with Enhertu have been delayed to the first half of 2024

The Sino-German alliance is planning to initiate the US-only Phase III DYNASTY-Breast02 trial with its HER2-targeting ADC DB-1303 in chemotherapy-naive patients with HER2-low and HR-positive breast cancer in the second-line or later setting, DualityBio founder and CEO

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