AstraZeneca plc (NYSE: AZN) combination drug for gastric cancer did not achieve “statistical significance” in patients. The British-Swedish pharmaceutical published Wednesday detailed results about the Phase III GOLD trial. Company’s share prices have slightly decreased in London, due to Lynparza results.
Findings demonstrate that Lynparza treatment in combination with placitaxel chemotherapy, did not offer a relevant advantage over paclitaxel chemotherapy alone. The multinational biologics company said results were not relevant, when taking statistics into account.
Researchers analyzed data of advanced gastric cancer patients and people, whose tumour “tested negative for Ataxia-Telangectasia Mutated (ATM) protein.” Sean Bohen, Executive Vice President at AstraZeneca, said the company remains confident in Lynparza.
“While there was a numerical trend for survival benefit with Lynparza plus paclitaxel in the trial, we are disappointed that this did not reach statistical significance. We look forward to presenting the data and remain confident in Lynparza’s clinical activity in a range of tumor types,” he said.
Lynparza (olaparib) is an oral medication that treats tumor DNA damage response (DDR) in order to kill cancer cells, said the pharmaceutical in a press release, issued Wednesday. It is currently authorized in more than 40 countries for use as monotherapy for patients with ovarian cancer.
In 2014, the U.S. Food and Drug Administration (FDA) approved Lynparza for women with advanced ovarian cancer “caused by a mutated BRCA gene.” The federal agency said it is the first drug of its kind that has been approved in the nation.
Study details: gastric cancer is disproportionately high in East Asia
AstraZeneca’s GOLD was a randomised, placebo-controlled trial. It aimed to determine the efficacy of Lynparza, when used alongside paclitaxel. Results were similar to those showed by paclitaxel alone.
The trial included 525 patients HER2- negative gastric cancer, said the pharmaceutical. It was carried out in China, Japan, South Korea and Taiwan, which have a major presence of gastric cancer. The medication was orally provided at doses of 100 mg, two times a day, alongside paclitaxel treatment.
Findings demonstrate that gastric cancer is “disproportionately high” in East Asia. Presence of the disease in that region is nine times higher than in the G6 countries combined, said AstraZeneca. The latter, is planning to launch six new medicines by 2020.
In 2016, there will be an estimated 26,370 new stomach cancer cases in the United States. 10,730 will die as a consequence of the same disease, said the U.S. National Cancer Institute (NCI)
Elements such as age, diet, stomach disease and Helicobacter pylori infection can interfere with the development of stomach cancer. It mostly affects elderly adults. 6 out of every 10 people diagnosed with the disease are 65 or older, said the NCI.
“Until the 1930s, stomach cancer was the leading cause of cancer death in the United States. Now, stomach cancer is well down on this list. The reasons for this decline are not completely known, but may be linked to increased use of refrigeration for food storage,” said the NCI.
A theory proposes that increments of fruit and vegetable consumption may be causing decreases of stomach cancer rates. Physicians also propose that antibiotics to kill Helicobacter pylori may be playing a major role in the eradication of the disease.
Prices of AstraZeneca’s shares decreased 1.11 percent in the London Stock Exchange, after results of the GOLD study were published.
Source: AstraZeneca (Press Release)