AstraZeneca's Lynparza has failed to hit targets in a Phase III trial assessing its effect on survival in patients with advanced gastric cancer.
According to data from the Phase III GOLD trial, a combination of the drug and paclitaxel chemotherapy failed to significantly improve overall survival compared to paclitaxel alone in either the overall population or patients whose tumour tested negative for Ataxia-Telangectasia Mutated (ATM) protein.
There was a numerical survival trend in the Lynparza/paclitaxel arm, but it did not meet statistical significance, and thus the trial failed to meet its primary endpoint, the firm noted.
AZ said it is disappointed with the result, but was also quick to note that the regimen studied in the GOLD study, at a low dose and in combination with chemotherapy, is different from those being evaluated in other late-stage trials.
"We remain confident in Lynparza's clinical activity in a range of tumour types, including its approved use in BRCA-mutated ovarian cancer," said the drug giant's chief medical officer Sean Bohen.
A full evaluation of the data is ongoing, results of which will be submitted for presentation at an upcoming medical meeting.
Lynparza is currently approved in over 40 countries as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
In the US it is cleared as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.