AstraZeneca agreed to pay $1 billion upfront under a deal with Daiichi Sankyo to develop the Japanese drugmaker's experimental TROP2-directed antibody-drug conjugate (ADC) DS-1062 for the treatment of multiple tumour types, the companies announced Monday. As part of the agreement, AstraZeneca will make further payments of up to $1 billion for the successful achievement of regulatory approvals and as much as $4 billion in sales-related milestones.
DS-1062, which utilises Daiichi Sankyo's DXd ADC technology, is designed to deliver chemotherapy selectively to cancer cells and to reduce systemic exposure. The drug is currently in Phase I development for the treatment of non-small-cell lung cancer and triple-negative breast cancer, with early-stage results presented at last year's American Society of Clinical Oncology (ASCO) annual meeting and World Conference on Lung Cancer (WCLC).
José Baselga, head of oncology research at AstraZeneca, noted that preliminary data in lung cancer played a large part in convincing the company of the compound's potential, and suggested that DS-1062 "could transform and will transform the therapy landscape." Baselga said "from there we are going straight to Phase III studies that will launch this year," adding that use in breast cancer would be pursued next.
Under the terms of the deal, the upfront payment will be staggered, with $350 million due from AstraZeneca on completion, $325 million after 12 months and $325 million after 24 months from the effective date of the agreement. The drugmakers will equally split development and commercialisation expenses, as well as profits relating to DS-1062 worldwide, except for Japan where Daiichi Sankyo will maintain exclusive rights and will pay AstraZeneca mid-single-digit royalties.
Sunao Manabe, CEO of Daiichi Sankyo, remarked that DS-1062 "will form a pillar of our next mid-term business plan," adding that the drug "has the potential to become a best-in-class TROP2 ADC in multiple tumours, including lung and breast cancers." As part of the agreement, Daiichi Sankyo will manufacture and supply DS-1062.
AstraZeneca indicated that the collaboration reflects its strategy to invest in ADCs as a class, the innovative nature of the technology and the successful existing collaboration with Daiichi Sankyo. In March last year, AstraZeneca paid $1.35 billion upfront as part of a deal potentially worth up to $6.9 billion to jointly develop and commercialise Daiichi Sankyo's ADC Enhertu (trastuzumab deruxtecan). The drug gained FDA approval in December for adults with unresectable or metastatic HER2-positive breast cancer who have received at least two prior anti-HER2-based regimens in the metastatic setting.
Commenting on DS-1062, AstraZeneca CEO Pascal Soriot said "we see significant potential in this antibody-drug conjugate in lung as well as in breast and other cancers that commonly express TROP2." Soriot added "we now have six potential blockbusters in oncology with more to come in our early and late pipelines."
Meanwhile, Bloomberg Intelligence analyst Sam Fazeli said that while data from early trials points to strong activity in lung cancer, there has been high toxicity with two deaths. Baselga indicated that the companies are working to mitigate the toxicity, while noting that the fatalities occurred in patients who had received the highest doses, which are unlikely to be retained for broad use.
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