Date: 2016-05-18
Type of information: Results
phase: 3
Announcement: results
Company: AstraZeneca (UK)
Product: Lynparza™ (olaparib)
Action mechanism: poly ADP-ribose polymerase (PARP) inhibitor/enzyme inhibitor. Lynparza™ (olaparib) is an oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. Lynparza™ is the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer, and has been launched in the U.S. and Europe. In addition to ovarian cancer, AstraZeneca is investigating the full potential of olaparib in multiple tumour types, with Phase III studies in second line gastric cancer, BRCA-mutated pancreatic cancer and adjuvant and metastatic BRCA-mutated breast cancers underway.
Disease: advanced gastric cancer
Therapeutic area: Cancer - Oncology
Country: China, Japan, South Korea, Taiwan
Trial details: GOLD was a randomised, double-blinded, placebo-controlled, multicentre Phase III trial to assess the efficacy and safety of Lynparza® in combination with paclitaxel, compared with paclitaxel alone. The trial enrolled Asian patients with advanced HER2-negative gastric cancer (including the gastro-oesophageal junction) who had progressed following 1st-line therapy. The trial, conducted in China, Japan, South Korea and Taiwan where gastric cancer is particularly prevalent, enrolled a total of 525 patients - 18% of whom had tumours that tested ATM negative by immunohistochemistry (IHC). Lynparza® was given orally at a dose of 100mg twice daily in combination with paclitaxel IV infusion over 1 hour at 80mg/m2 weekly on days 1, 8 and 15 of a 28 day schedule.
Latest news: • On May 18, 2016, AstraZeneca announced that Lynparza® (olaparib) in combination with paclitaxel chemotherapy, compared with paclitaxel chemotherapy alone, did not meet the primary endpoint of overall survival (OS) in the Phase III GOLD trial in advanced gastric cancer patients, in either the overall population or patients whose tumour tested negative for ataxia-telangectasia mutated (ATM) protein. Whilst there was a numerical survival trend in the Lynparza plus paclitaxel arm, it did not meet statistical significance. The reported incidence of adverse events for Lynparza® in combination with paclitaxel compared with paclitaxel alone was similar. A full evaluation of the data is ongoing and the results will be submitted for presentation at an upcoming medical meeting.
