AstraZeneca and Merck announced the Phase 3 GY004 trial, which examined cediranib in combination with LYNPARZA versus platinum-based chemotherapy in patients with platinum-sensitive relapsed ovarian cancer, did not meet the primary endpoint of progression free survival. The trial was led by NRG Oncology and sponsored by the U.S. National Cancer Institute (NCI) in collaboration with AstraZeneca.
GY004 was an open-label, randomized, multicenter, trial evaluating cediranib and Lynparza or Lynparza alone compared to standard platinum-based chemotherapy in patients with recurrent platinum-sensitive ovarian cancer, fallopian tube, or primary peritoneal cancer patients. The trial included patients both with and without a BRCA mutation. The trial did not meet the primary endpoint in the intent-to-treat (ITT) population of a statistically significant improvement in progression-free survival (PFS) with cediranib in combination with LYNPARZA vs. platinum-based chemotherapy.
The NCI and NRG Oncology plan to present complete data at an upcoming medical conference.
About Lynparza (olaparib)
Lynparza is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of tumor types with defects and dependencies in the DDR.
AstraZeneca and Merck & Co. entered into a global strategic oncology collaboration to co-develop and co-commercialize Lynparza in July of 2017.
Cediranib is an oral vascular endothelial growth factor receptor (VEGFR) inhibitor that blocks blood vessel growth that helps tumors to grow.Source: Merck