阿斯利康ESMO公布胃癌ADC药物Sone-Ve三期阳性结果，合作方和黄医药赛沃替尼肺癌组合OS亦阳性

AstraZeneca Plc’s experimental stomach cancer drug doubled the time patients survived in a late-stage trial, boosting prospects for a potential new blockbuster.

The medicine, an antibody drug conjugate dubbed sone-ve, helped patients whose gastric cancer had spread despite other treatments live for five months longer than those receiving chemotherapy and other cancer drugs.

The results reinforce Astra’s belief that antibody drug conjugates — a class of complex targeted therapies — can replace chemotherapy in many tumors, said Susan Galbraith, the UK drugmaker’s executive vice president of oncology hematology research and development.

Shares of AstraZeneca rose about 1% in early trading in London on Monday. They were down 7% this year through Friday’s close.

The drug’s efficacy “looks good,” Barclays analyst James Gordon said in a note. Still, there is some investor caution given many gastric cancer patients are in China “where there could be cost constraints and local fast followers,” he said.

Astra has pegged potential annual sales for the treatment, whose full name is sonesitatug vedotin, at between $3 billion and $5 billion. It targets a protein found in the lining of the stomach that’s expressed in some gastric cancers.

In the trial presented Sunday at the European Society for Medical Oncology meeting, the drug helped patients whose cancer had progressed after one form of treatment live longer, but the greater benefit was for those getting it after two prior lines of medicine.

For them, sone-ve will likely become the new treatment strategy, said Salah-Eddin Al-Batran, managing director of the Frankfurt Institute of Clinical Cancer Research, who wasn’t involved in the study. More data is needed, however, before widely adopting the drug for earlier treatment, he said.

The drug didn’t show it helped delay the disease’s progression, which Galbraith said could be because gastric cancer progression is difficult to measure.

Bloomberg Intelligence said before the conference sone-ve could bring in as much as $2.2 billion in annual sales if it showed a convincing survival gain.

In the study, more patients dropped out due to side effects when they took the older medicines than sone-ve, and the number of deaths related to treatment was roughly similar. Astra is talking to health authorities about the data, said Dave Fredrickson, executive vice-president of the oncology business unit.

Protein Target

There is one approved drug – Astellas Pharma Inc.’s Vyloy – that targets the same protein, called Claudin 18.2. But it is only suitable for people whose tumors express much higher levels of the protein, limiting the number of eligible patients.

Other drugmakers are going after the same target. In a different population of patients with stomach cancer, Takeda Pharmaceutical Co.’s arcotatug tavatecan helped volunteers live more than three months longer, according to data presented at the congress.

What sets Takeda’s drug apart is the reduced gastrointestinal side-effects, said Phuong Khanh Morrow, head of Takeda’s oncology therapeutic area unit. The mechanism of action “really reduces the risk of any nausea, vomiting, and diarrhea,” she said.

Other data from Astra at the meeting included a late-stage trial of blockbuster Tagrisso combined with Orpathys, a medicine from Astra and Hutchmed, for patients with a type of non-small cell lung cancer.

The combination delayed the disease’s progression by over two months and also extended life by almost five months compared with chemotherapy. Patients were particularly difficult to treat due to a type of protein being overly present in their cancer cells.

The data will likely “change the standard of care,” said Natasha Leighl, professor in the Department of Medicine at the University of Toronto.

Both Tagrisso and Orpathys are tablets that can be taken at home, with the medicines having a manageable safety profile, the researchers said.