Survival period doubled! AstraZeneca's new stomach cancer drug Sone-ve aims for $5 billion in annual sales, ADC takes another step towards replacing chemotherapy

According to Zhihu Finance APP, AstraZeneca (AZN.US)'s investigational gastric cancer drug has doubled patient survival in a late-stage trial, boosting the potential prospects for another blockbuster medication.

This antibody-drug conjugate (ADC) named sone-ve helped patients whose gastric cancer had spread and were no longer responding to other treatments survive 5 months longer than those receiving chemotherapy and other anti-cancer drugs.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, stated that these results reinforce AstraZeneca's belief that antibody-drug conjugates—a type of complex targeted therapy—could replace chemotherapy in the treatment of many tumors.

AstraZeneca has set an expected potential annual sales range of $3 billion to $5 billion for the drug, fully named sonesitatug vedotin. The medicine targets a protein on the stomach lining, which is expressed in some gastric cancers.

In the study presented Sunday at the European Society for Medical Oncology (ESMO) conference, the drug helped patients whose disease continued to progress after first-line treatment to live longer, but those who had already undergone two lines of therapy benefited even more from the drug.

Salah-Eddin Al-Batran, Managing Director of the Frankfurt Institute for Clinical Cancer Research, said that for this group of patients, sone-ve could likely become a new treatment strategy. He personally was not involved in the research.

However, Al-Batran noted that more data is needed before the drug can be widely used for earlier lines of treatment.

The drug did not demonstrate it could delay disease progression, which Galbraith said may be because measuring disease progression in gastric cancer is challenging.

Prior to the conference, industry research analysts indicated that if sone-ve shows compelling survival benefits, its annual sales could reach up to $2.2 billion.

In the study, a greater proportion of patients on older drugs withdrew due to side effects compared to the sone-ve group, while the number of treatment-related deaths was roughly similar. Dave Fredrickson, Executive Vice President of Oncology at AstraZeneca, noted the company is in discussions with health regulatory agencies on these data.

Protein Target

There is currently one approved drug—Astellas Pharma Inc.'s Vyloy—that targets the same protein, Claudin 18.2. However, it is only suited for patients whose tumors express much higher levels of this protein, limiting the eligible patient population.

Other pharmaceutical companies are also pursuing the same target. Among a different group of gastric cancer patients, Takeda's arcotatug tavatecan helped participants live more than 3 months longer, as data presented at the same conference showed.

Phuong Khanh Morrow, head of oncology for Takeda, said what makes Takeda's drug different is lower gastrointestinal side effects. She said its mechanism of action "truly reduces the risk of any nausea, vomiting, and diarrhea."

AstraZeneca also presented other data at this conference, including late-stage trial results for its blockbuster Tagrisso (osimertinib) in combination with Orpathys (savolitinib) for a form of non-small cell lung cancer.

Compared to chemotherapy, the combination therapy delayed disease progression by more than 2 months and extended survival by nearly 5 months. These patients are particularly difficult to treat because a certain protein is over-expressed in their cancer cells.

Natacha Lii, Professor at the Department of Medicine, University of Toronto, said these data are likely to "change the standard of care."

Researchers stated that both Tagrisso and Orpathys are tablets that can be taken at home, and the safety profile of both drugs is manageable.