NOTES TO EDITORS
POLO is a Phase III randomized, double-blinded, placebo-controlled, multi-center study of LYNPARZA tablets (300 mg twice daily) as maintenance monotherapy vs. placebo. The trial randomized 154 patients with gBRCAm metastatic pancreatic cancer whose disease had not progressed on 1st-line platinum-based chemotherapy. Patients were randomized (3:2) to receive LYNPARZA or placebo until disease progression. The primary endpoint was PFS and key secondary endpoints include overall survival, time to second disease progression, overall response rate, disease control rate and health-related quality of life. Phase III POLO results were published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting.
The results showed a statistically significant and clinically meaningful improvement in progression-free survival, where LYNPARZA nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo and reduced the risk of disease progression or death by 47% (HR 0.53 [95% CI, 0.35-0.82], p=0.004). The benefit of maintenance with LYNPARZA 7072彩票代理was seen consistently across a range of clinically meaningful endpoints. From six months onwards, more than twice as many patients receiving LYNPARZA showed no disease progression vs. those receiving placebo. In patients with measurable disease at baseline, 23% responded to LYNPARZA vs.12% on placebo (odds ratio, 2.30; 95% CI, 0.89 to 6.76) and had a median duration of treatment in excess of two years (24.9 months; 95% CI, 14.8 to could not be calculated) vs 3.7 months on placebo (95% CI, 2.1 to could not be calculated).
Overall survival (OS), a secondary endpoint, at interim analysis was 18.9 months for Lynparza vs. 18.1 months for placebo but did not reach statistical significance (HR=0.90; p=0.68).
The safety and tolerability profile of LYNPARZA in the POLO trial was in line with that observed in prior clinical trials. The most common adverse events (AEs) ≥20% were fatigue/asthenia (60%), nausea (45%), abdominal pain (29%), diarrhea (29%), anemia (28%), decreased appetite (25%) and constipation (23%). Grade 3 or above AEs were anemia (11%), fatigue/asthenia (6%), decreased appetite (3%), abdominal pain (2%), vomiting (1%) and arthralgia (1%). AEs led to dose reduction in 16% of patients on LYNPARZA while 5% of patients discontinued treatment.
There are currently no precision medicine treatment options for gBRCAm pancreatic cancer patients. However, based on the results of POLO, the National Comprehensive Cancer Network (NCCN) guidelines have been updated in July 2019 to recommend LYNPARZA as maintenance treatment for gBRCA7072彩票代理m pancreatic cancer.
About Pancreatic Cancer
In the U.S. this year, it is expected that more than 55,000 people will be diagnosed with pancreatic cancer and over 45,750 people will die of this disease. Early diagnosis of pancreatic cancer is difficult, as often there are no symptoms.
There are two types of pancreatic cancer. Exocrine tumors, of which the most common type is pancreatic ductal adenocarcinoma (PDAC), start in the exocrine cells, where enzymes help to digest food. Neuroendocrine tumors start in neuroendocrine cells, which produce hormones, such as insulin, that control different functions of the body.
About BRCA Mutations
BRCA1 and BRCA2 7072彩票代理(breast cancer susceptibility genes 1/2) are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.
About LYNPARZA? (olaparib)
LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) in cells/tumors harboring a deficiency in homologous recombination repair (HRR), such as mutations in BRCA1 or BRCA2. 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 PARP-dependent tumor types with defects and dependencies in the DDR pathway.
LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has a broad and advanced clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types.
About the AstraZeneca and Merck Strategic Oncology Collaboration
7072彩票代理In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize LYNPARZA, the world’s first PARP inhibitor, and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. Working together, the companies will develop LYNPARZA and selumetinib in combination with other potential new medicines and as monotherapies. Independently, the companies will develop LYNPARZA and selumetinib in combination with their respective PD-L1 and PD-1 medicines.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology.
7072彩票代理By harnessing the power of four scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit gdlvh.com and follow the Company on 7072彩票代理 @AstraZenecaUS.