pharmatimesMarch 16, 2020
Tag: Cediranib , Lynparza , ovarian cancer , AstraZeneca , GY004
AstraZeneca and MSD have reported results from the Phase III GY004 trial, in which potential new medicine cediranib, when added to Lynparza (olaparib), did not meet the trial’s primary endpoint.
The study, which was evaluating the safety and efficacy of the drug in platinum-sensitive relapsed ovarian cancer, did not meet the primary endpoint in the intent-to-treat (ITT) population of a statistically significant improvement in progression-free survival (PFS) when the drug was added to Lynparza, compared to platinum-based chemotherapy.
The safety and tolerability profiles observed in GY004 were also generally consistent with those known for each medicine, despite the setbacks.
José Baselga, executive vice president, oncology at AstraZeneca says that the company "remains committed to expanding on the benefits already demonstrated with Lynparza for patients with advanced ovarian cancer. We will work closely with NRG Oncology and the NCI to review the full results to inform our ongoing research."
Ovarian cancer is the eighth most common cause of death from cancer in women worldwide. In 2018, there were nearly 300,000 new cases diagnosed and around 185,000 deaths.
Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, is approved for the treatment of advanced ovarian cancer, metastatic breast cancer and pancreatic cancer and has been used to treat over 30,000 patients worldwide.
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