AstraZeneca and Merck & Co. announced Thursday that a Phase III trial investigating the addition of the experimental oral VEGFR inhibitor cediranib to the PARP inhibitor Lynparza (olaparib) in patients with platinum-sensitive relapsed ovarian cancer failed to significantly improve progression-free survival (PFS) versus platinum-based chemotherapy. José Baselga, executive vice president of oncology R&D at AstraZeneca, called the outcome "disappointing," adding that the full results will be reviewed "to inform our ongoing research."
The GY004 trial, which was led by NRG Oncology and sponsored by the US National Cancer Institute (NCI), randomised patients with recurrent platinum-sensitive ovarian cancer, fallopian tube or primary peritoneal cancer, with or without a BRCA mutation, to receive cediranib added to Lynparza, Lynparza monotherapy or standard platinum-based chemotherapy. The study's main goal in the intent-to-treat population is improvement in PFS with cediranib plus Lynparza versus platinum-based chemotherapy.
The companies noted that the NCI and NRG Oncology will present the full data at a forthcoming medical meeting. AstraZeneca and Merck indicated that the safety and tolerability profiles observed in the GY004 trial were "generally consistent" with those known for each medicine.
Lynparza is currently approved in over 70 countries for the maintenance treatment of platinum-sensitive relapsed ovarian cancer, as well as a number of markets as first-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy.
In 2016, AstraZeneca withdrew a filing in Europe seeking clearance of cediranib in combination with platinum-based chemotherapy, followed by maintenance monotherapy, to treat adults with platinum-sensitive relapsed ovarian cancer. The decision came after the European Medicines Agency had raised concerns over whether the drug's side effects, such as diarrhoea and fatigue, outweighed its benefits, while the agency also questioned the way the Phase III ICON6 study, used to support the filing, was conducted.
Cediranib is also being evaluated in combination with Lynparza in advanced ovarian cancer in the Phase II CONCERTO trial, Phase II/III GY005 study and the Phase III ICON9 trial.
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