AstraZeneca has announced a landmark collaboration with Japanese pharmaceutical company Daiichi Sankyo, committing up to $6.9 billion to co-develop and commercialize trastuzumab deruxtecan (DS-8201), a novel antibody-drug conjugate targeting HER2-expressing cancers.
The partnership involves an immediate upfront payment of $1.35 billion from AstraZeneca, with half due upon execution and the remainder payable within 12 months. The agreement includes potential additional payments of up to $5.55 billion tied to regulatory milestones ($3.8 billion) and sales achievements ($1.75 billion).
Innovative Mechanism of Action
Trastuzumab deruxtecan represents a significant advancement in targeted cancer therapy, combining the HER2-targeting capabilities of trastuzumab with a proprietary deruxtecan payload. The drug specifically targets HER2 receptors on cancer cells, delivering a potent chemotherapy agent while sparing healthy tissue.
Clinical Development Program
The drug has already secured FDA Breakthrough Therapy Designation for HER2-positive locally-advanced or metastatic breast cancer in patients previously treated with trastuzumab and pertuzumab who experienced disease progression after trastuzumab emtansine therapy.
Daiichi Sankyo has initiated an extensive clinical development program across North America, Europe, and Asia, encompassing five pivotal trials in HER2-expressing breast and gastric cancers. Additional studies are exploring the drug's potential in:
- Advanced colorectal cancer (Phase 2)
- Metastatic non-squamous HER2-overexpressing or HER2-mutated NSCLC (Phase 2)
- Combination therapy with nivolumab for HER2-expressing metastatic breast and bladder cancers (Phase 1)
Strategic Implications
"Trastuzumab deruxtecan could become a transformative new medicine for the treatment of HER2-positive breast and gastric cancers," stated Pascal Soriot, CEO of AstraZeneca. "It also has the potential to redefine breast cancer treatment as the first therapy for HER2-low expressing tumours."
The collaboration aligns with AstraZeneca's oncology strategy, which focuses on four key areas: tumor drivers and resistance, DNA damage response, immuno-oncology, and antibody-drug conjugates.
Partnership Structure
Under the agreement terms, both companies will jointly develop and commercialize trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo retains exclusive rights. Daiichi Sankyo will maintain sole responsibility for manufacturing and supply.
The financial impact is expected to be neutral to AstraZeneca's core earnings in 2019, with positive contributions beginning in 2020 and significant impact anticipated by 2023.
