Dive Brief:
- AstraZeneca’s ovarian cancer drug Lynparza failed to improve overall survival in patients with advanced gastric cancer in a phase 3 study, the company said Wednesday.
- While the treatment arm did experience a numerical survival trend, it did not meet statistical significance. Lynparza was paired with paclitaxel chemotherapy and compared to chemo alone.
- Lynparaza, a PARP inhibitor, is approved in the US and the EU for the treatment of BRCA-associated advanced ovarian cancer and is a cornerstone of AstraZeneca's DNA damage-response (DDR) research program.
Dive Insight:
Lynparza’s failure in gastric cancer is a setback for AstraZeneca’s plans to expand the drug’s indication. “We are disappointed that this did not reach statistical significance,” said Sean Bohen, chief medical officer at AstraZeneca.
AstraZeneca was quick to note in a statement on the news that Lynparza will continue to be evaluated against other tumor types.
But the company has high hopes for its DNA damage-response research program, and Lynparza is a “foundation” asset for its plans in this field.
Bohen noted the tested regimen, which was low dose and in combo with chemotherapy, differed from the other phase 3 trials in the Lynparza program.
The company had conducted the trial at various centers in Asia, where there is a high prevalence of gastric cancer.
When Lynparza was approved in late 2014, it was seen a breakthrough in the treatment of advanced ovarian cancer, with improvements in progression-free survival.