Survival period doubled! AstraZeneca's new gastric cancer drug sone-ve targets $5 billion in annual sales, ADC takes another step toward replacing chemotherapy.

AstraZeneca PLC Sponsored ADR (AZN.US)'s investigational gastric cancer drug doubled patient survival in a late-stage trial, adding weight to another potential blockbuster. The drug, called sone-ve, an antibody-drug conjugate (ADC), helped patients whose gastric cancer had spread and who had failed other treatments live five months longer than those receiving chemotherapy and other anticancer drugs. Susan Galbraith, Executive Vice President of Oncology Hematology R&D at AstraZeneca PLC Sponsored ADR, said the results reinforce AstraZeneca PLC Sponsored ADR's belief that antibody-drug conjugatesa class of complex targeted therapiescould replace chemotherapy in the treatment of many tumors. AstraZeneca PLC Sponsored ADR has set a potential annual sales forecast of $3 billion to $5 billion for the drug, whose full name is sonesitatug vedotin. The drug targets a protein on the lining of the stomach wall that is expressed in certain gastric cancers. In the study presented Sunday at the European Society for Medical Oncology (ESMO) conference, the drug helped patients whose disease had progressed after first-line treatment live longer, but the benefit was greater in patients who received the drug after having already undergone two lines of treatment. Salah-Eddine Al-Batran, Managing Director of the Frankfurt Institute for Clinical Cancer Research, said sone-ve is likely to become a new treatment strategy for this type of patient. He was not involved in the study. However, Al-Batran said more data are needed before the drug is widely used in earlier lines of treatment. The drug failed to show it could delay disease progression, which Galbraith said may be because disease progression in gastric cancer is difficult to measure. Ahead of the conference, industry research analysts said that if sone-ve could demonstrate a convincing survival benefit, its annual sales could reach up to $2.2 billion. In the study, a higher proportion of patients treated with the older drug withdrew due to side effects than in the sone-ve group, while treatment-related deaths were roughly comparable. Dave Fredrickson, Executive Vice President of AstraZeneca PLC Sponsored ADR's Oncology Business Unit, said AstraZeneca PLC Sponsored ADR is in discussions with health regulators about these data. Protein Target One approved drug already existsAstellas Pharma Inc.'s Vyloythat targets the same protein, called Claudin 18.2. But it is only suitable for patients whose tumors express the protein at much higher levels, limiting the number of patients eligible for treatment. Other drugmakers are also pursuing the same target. In another group of gastric cancer patients, Takeda Pharmaceutical Co. Ltd. Sponsored ADR's arcotatug tavatecan helped subjects live more than three months longer, with the data presented at this conference. Phuong Khanh Morrow, Takeda's head of oncology therapeutic area, said Takeda's drug differs in having fewer gastrointestinal side effects. She said its mechanism of action "really reduces any risk of nausea, vomiting and diarrhea." Other data AstraZeneca PLC Sponsored ADR presented at the conference included a late-stage trial of its blockbuster drug Tagrisso (osimertinib) combined with Orpathys (savolitinib) in patients with a type of non-small cell lung cancer. Compared with chemotherapy, the combination delayed disease progression by more than two months and extended survival by nearly five months. These patients are particularly difficult to treat because a certain protein is overexpressed in their cancer cells. Natasha Leighl, a professor in the Department of Medicine at the University of Toronto, said the data are likely to "change the standard of care." The researchers said both Tagrisso and Orpathys are tablets that can be taken at home, and the safety profiles of the two drugs are manageable.