By Ruchi Jhonsa, Ph.D.
After getting success with Enhertu, a Daiichi Sankyo antibody drug-conjugate (ADC) targeting breast cancer, AstraZeneca has decided to strengthen this collaboration further by entering a $6 billion agreement with the company for its second ADC, DS-1062. The drug is currently in Phase 1 clinical development for non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). With this deal, AstraZeneca further strengthened its foothold in the oncology space.
Antibody-drug conjugates are novel, highly potent drugs built by attaching a small molecule anticancer drug to an antibody by a permanent linker. The drug identifies cancer cells by an antibody directed against protein specific for cancer cells. Once tethered, the antibody is internalized by the cancer cells together with the drug. This method delivers the drug specifically to the diseased cells, thereby reducing the risk of systemic exposure and associated side effects.
Daiichi Sankyo’s DS-1062 comprises a humanized anti-TROP2 monoclonal antibody linked to topoisomerase I inhibitor. It targets TROP2, a transmembrane protein with an extracellular domain that is overexpressed by tumors of the lung, breast, pancreas, and the other organs. Research indicates that high TROP2 expression is associated with cancer cell growth and proliferation and poor patient survival.
Under the deal, AstraZeneca will pay Daiichi Sankyo a guaranteed upfront payment of $1 billion in three installments of $325 million each. Daiichi Sankyo is also bound to receive $5 billion worth of contingent payments that includes $1 billion for the achievement of future regulatory milestones and $4 billion for sales-related milestones. AstraZeneca will equally share the cost of development and commercialization of DS-1062 along with any profits earned from its sale, except for Japan where Daiichi will have full control.
“DS-1062, one of our lead DXd ADCs that will form a pillar of our next mid-term business plan, has the potential to become a best-in-class TROP2 ADC in multiple tumors, including lung and breast cancers,” said Sunao Manabe, Representative Director, President, and CEO of Daiichi Sankyo Company, Limited. “This new strategic collaboration with AstraZeneca, a company with extensive experience and significant expertise in the global oncology business, will enable us to deliver DS-1062 to more patients around the world as quickly as possible. As we have done with Enhertu, we will jointly design and implement strategies to maximize the value of DS-1062.”
Daiichi is expected to book sales in the U.S., certain countries in Europe, and other markets where it has affiliates, whereas AstraZeneca will cover the rest of the markets including China, Australia, Canada, and Russia.
DS-1062 Shows Impressive Response
In the Phase 1 trial, 26% of 46 advanced NSCLC patients administered 0.27 mg/Kg to 10.0mg/Kg dose, had a partial response to the drug. Five of the seven patients who received an 8.0mg/Kg drug dose showed a confirmed partial response. However, almost 20% of the patients showed grade 3 or worse treatment-related adverse events. Of the 34 people who received the most effective dose of the drug, six had potential interstitial lung disease. All except one of the cases was shown treatment-related.
“We see significant potential in this antibody-drug conjugate in lung as well as in breast and other cancers that commonly express TROP2,” said Pascal Soriot, CEO, AstraZeneca. “We are delighted to enter this new collaboration with Daiichi Sankyo and to build on the successful launch of Enhertu to further expand our pipeline and leadership in oncology. We now have six potential blockbusters in oncology with more to come in our early and late pipelines.”
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