Phase III GY004 Trial of Lynparza (Olaparib) Combined with Cediranib Fails to Meet Primary Endpoint in Platinum-Sensitive Relapsed Ovarian Cancer

March 13, 2020/BioonBIOON/---AstraZeneca(AstraZeneca) and its partner Merck & Co. recently announced high-level results from the Phase III GYOO4 trial evaluating Lynparza (Chinese brand name: Lipuzhuo; generic name: olaparib, olaparib tablets) for the treatment of recurrent platinum-sensitive ovarian cancer. This study primarily assessed the efficacy and safety of adding cediranib to Lynparza compared with platinum-based chemotherapy in patients with platinum-sensitive recurrent ovarian cancer.

The results showed that the study failed to meet its primary endpoint: in the intent-to-treat (ITT) population, the cediranib plus Lynparza combination therapy group did not achieve a statistically significant improvement in progression-free survival (PFS) compared with the platinum-based chemotherapy group. The safety and tolerability observed in this study were generally consistent with the known profiles of each drug. Full data from the study will be presented at an upcoming medicalConferencepublished above.

AstraZenecaTumorJosé Baselga, Executive Vice President of Research and Development, stated, “Although these results are disappointing, we remain committed to expanding the proven benefits of Lynparza for patients with advanced ovarian cancer. We will work closely with NRG Oncology and the NCI to review the full results, which will inform our ongoing studies.”

Roy Baynes, Chief Medical Officer, Senior Vice President, and Head of Global Clinical Development at Merck Research Laboratories, stated: “Ovarian cancer is one of the most difficult to detect in its early stages”Diagnosisand treatmentTumorone. AstraZeneca, Merck Sharp & Dohme, and our partners will continue through our jointClinical Trials“Develop projects to explore methods that can help patients.”

Ovarian cancer is the eighth most common cause of cancer-related death among women worldwide. In 2018, there were nearly 300,000 newly diagnosed cases and approximately 185,000 deaths. Most patients areDiagnosisFor advanced-stage (Stage III or IV) ovarian cancer, the 5-year survival rate is approximately 30%. The primary goal of treating recurrent ovarian cancer is to delay disease progression as much as possible.

Cediranib is an oral vascular endothelial growth factor receptor (VEGFR) inhibitor that blocks the angiogenesis supporting tumor growth. In various cancers, cediranib monotherapy and combination therapy have both demonstrated anti-Tumoractivity, including ovarian cancer,Breast Cancer, colorectal cancer, renal cell carcinoma, lung cancer, sarcoma, and glioblastoma. Currently, the combination of cediranib and Lynparza for the treatment of advanced ovarian cancer is being evaluated in the Phase II CONCERTO trial, the Phase II/III GY005 trial, and the Phase III ICON9 trial.

Lynparza is the first PARP inhibitor to be marketed globally, first approved in the United States in December 2014FDAApproved. To date, the drug has been approved in 73 countries worldwide for maintenance treatment of platinum-sensitive recurrent ovarian cancer, regardless of BRCA status. In multiple countries, including the United States, the European Union, Japan, and China, it is also approved as a first-line maintenance therapy for advanced ovarian cancer with BRCA mutations (BRCAm) in patients who have achieved response following platinum-based chemotherapy. Furthermore, it has been approved in 58 countries, including the United States and Japan, for germline BRCAm HER2-negative metastatic breast cancer in patients previously treated with chemotherapy; in the European Union, this indication includes locally advanced breast cancer. In the United States, Lynparza is also approved for first-line maintenance treatment of metastatic pancreatic cancer with germline BRCA mutations. Currently, regulatory reviews for Lynparza in the treatment of ovarian, breast, and pancreatic cancers are ongoing in other jurisdictions.

AstraZeneca and MSD entered into a global strategic oncology collaboration in July 2017 to jointly develop and commercialize Lynparza and another MEK inhibitor, selumetinib, for the treatment of various types of tumors. Within the class of PARP inhibitors, Lynparza has the broadest and most advancedClinical TrialDevelopment project. Currently, both parties are collaborating to investigate Lynparza as a monotherapy and in combination therapy for a broad range ofTumortherapeutic potential.

In the Chinese market, Lynparza (Lynparza) was approved in August 2018 for maintenance treatment of platinum-sensitive recurrent ovarian cancer. Lynparza is the first targeted therapy approved for ovarian cancer in China, marking the entry of PARP inhibitors into the era of ovarian cancer treatment in China.In early December 2019, Lynparza (olaparib) was again approved for first-line maintenance treatment of patients with advanced ovarian cancer harboring BRCA mutations. Benefiting from China’s strong support for pharmaceutical innovation and the accelerated approval of new drugs urgently needed in clinical practice, Lynparza (olaparib) became the first PARP inhibitor approved in China for first-line maintenance therapy in ovarian cancer. On November 28, 2019, Lynparza (olaparib) was included in the National Reimbursement Drug List. (Bioon.com)

Original Source:Update on Phase III GY004 trial for cediranib added to Lynparza in platinum-sensitive relapsed ovarian cancer