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March 12, 2020

AstraZeneca’s trial of oncology drug fails to meet primary endpoint

AstraZeneca and MSD have reported that the Phase III GY004 trial for cediranib has failed to meet the primary endpoint in platinum-sensitive relapsed ovarian cancer.

AstraZeneca and MSD have reported that the Phase III GY004 trial for cediranib has failed to meet the primary endpoint in platinum-sensitive relapsed ovarian cancer.

Led by NRG Oncology and sponsored by the US National Cancer Institute (NCI), the trial evaluated the efficacy and safety of the potential new medicine cediranib added to Lynparza (olaparib) versus platinum-based chemotherapy in patients.

The company noted that the trial failed to meet the primary endpoint of a statistically significant improvement in progression-free survival (PFS) with cediranib in the intent-to-treat (ITT) population.

Oral vascular endothelial growth factor receptor (VEGFR) inhibitor Cediranib prevents the growth of blood vessels supporting tumour growth.

AstraZeneca Oncology R&D executive vice-president José Baselga said: “Despite these disappointing results, we remain 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.”

The safety and tolerability profiles observed in the trial were generally consistent with those known for each medicine.

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AstraZeneca and MSD announced a global strategic oncology collaboration in July 2017 to co-develop and co-commercialise Lynparza, which is currently approved in 73 countries.

It is a PARP inhibitor intended for the treatment of platinum-sensitive relapsed ovarian cancer.

MSD Research Laboratories chief medical officer Roy Baynes said: “Ovarian cancer is one of the most difficult tumours to diagnose and treat early. AstraZeneca, MSD and our partners will continue to explore ways to help patients through our joint clinical trial development programme.”

Ovarian cancer is reported to be the eighth most common cause of death from cancer in women globally.

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