AstraZeneca’s Lynparza fails to meet primary endpoint in Phase III gastric cancer trials

pharmafile | May 18, 2016 | News story | Research and Development AstraZeneca, failed to meet endpoint, gastric trail, lynparza, phase III 

AstraZeneca has announced that its treatment for advanced gastric cancer, Lynparza (olaparib), failed to meet the primary endpoint of overall survival in the Phase III GOLD trial.

When used in combination with paclitaxel chemotherapy, compared with the use of chemo alone, Lynparza did not meet the primary endpoint in either the overall population or patients whose tumour tested negative for Ataxia-Telangectasia Mutated protein. The company indicates that while there was a numerical survival trend in the Lynparza plus chemo arm, it did not reach statistical significance.

Gastric and gastroesophageal junction adenocarcinomas account for around 84% of all cancers of the stomach. The incidence of gastric cancer is disproportionally high in East Asia, with annual incidence nine times higher than in the G6 countries combined.

Lynparza is a first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA damage response pathway deficiencies to preferentially kill cancer cells. The drug was approved by the European Medicines Agency in late 2014 for advanced BRCA-mutated ovarian cancer, while it was approved in a similar indication by the National Institute for Health and Care Excellence (NICE) for use in the NHS in England after a price reduction was agreed.

Sean Bohen, chief medical officer at AstraZeneca, says: “While there was a numerical trend for survival benefit with Lynparza plus paclitaxel in the GOLD trial, we are disappointed that this did not reach statistical significance. This particular regimen in the GOLD study, at a low dose and in combination with chemotherapy, differs from other Phase III trials in the Lynparza programme. We look forward to presenting the GOLD data and remain confident in Lynparza’s clinical activity in a range of tumour types, including its approved use in BRCA-mutated ovarian cancer.”

Sean Murray

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