MADRID--AstraZeneca is readying to file the first of a new portfolio of targeted cancer drugs for regulatory approval, moving to cement its position in one of the fastest-growing corners of the oncology market.
Through its alliance with Japan's Daiichi Sankyo, AstraZeneca has been at the forefront of the latest generation of a class of medicines known as antibody-drug conjugates, or ADCs, which aim to replace standard chemotherapy by striking tumors directly with a toxic agent. But the U.K. drugmaker is now developing an in-house lineup.
AstraZeneca on Sunday released results from the first late-stage trial of a fully owned ADC, showing it reduced the risk of death by 42% in patients with advanced gastric cancer who had been previously treated. The data were presented at the annual congress of the European Society for Medical Oncology in Madrid.
"It demonstrates that we can continue to bring antibody-drug conjugates into areas where classic chemotherapy has historically been the standard of care," the head of AstraZeneca's oncology business, David Fredrickson, said in an interview. "It really paves the way for the multiple other antibody drug conjugates that we have in our portfolio."
ADCs have been around for more than two decades. But it took drugmakers years to refine the technology behind their three-part design--an antibody that identifies a target protein on the surface of tumor cells, an anticancer agent that kills them, and a chemical "linker" that holds both together.
While AstraZeneca had been working on the field for a while, its 2019 partnership with Daiichi for cancer drug Enhertu boosted its efforts. The companies teamed up again for another ADC, Datroway, a year later.
Learning to develop its own ADCs was a key reason for AstraZeneca entering into the partnership with Daiichi, analysts at Bernstein wrote in a recent research note.
"We saw something that was different from the previous data that had been around," AstraZeneca's oncology research-and-development head, Susan Galbraith, told journalists on the sidelines of the ESMO congress.
Many of the world's biggest pharmaceutical companies are investing in ADCs. The drug class has been among the fastest-growing by dealmaking volumes since 2019, according to IQVIA, a provider of healthcare data.
Just this year, Gilead Sciences snapped up German ADC specialist Tubulis for up to $5 billion, Novartis bought Britain's Myricx Bio for up to $1.5 billion and Roche Holding secured rights to several ADCs through a series of licensing deals in China.
"There's a huge opportunity there for multiple companies to have different programs," Galbraith said.
AstraZeneca's first fully owned ADC, sonesitatug vedotin or sone-ve, could face competition. Takeda Pharmaceuticals presented at ESCO data for a rival ADC, arcotatug tavatecan.
Galbraith said the sone-ve dataset is robust enough to take it to regulators, even as the company continues to investigate the medicine in earlier stages of gastric cancer and other types of tumors, as well as in combinations with other drugs.
AstraZeneca licensed sone-ve from China's KYM Biosciences in 2023. Two other ADCs that came from AstraZeneca's own labs, puxi-sam and torvu-sam, are being tested in late-stage trials and the company has more in early-stage development. Along the way, there were stumbles. The company disclosed in its second-quarter results that it had dropped a couple of ADCs.
Back in 2024, AstraZeneca estimated its portfolio of wholly owned ADCs could generate annual peak revenue of more than $5 billion. It has recently broken out peak revenue estimates for sone-ve of $3 billion to $5 billion, while maintaining its peak-sales guidance of more than $5 billion for the rest of the portfolio.
"The confidence level in the [sone-ve] profile that we've got and the value that is bringing is obviously larger," Galbraith said. "As we see the same thing with puxi-sam and torvu-sam, I think we'll also be able to think about what their ultimate value will be."
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