Major Advancement in BRCAm Ovarian Cancer: AstraZeneca and Merck’s Lynparza (Olaparib) Approved by UK NICE for First-Line Maintenance Therapy
Jul 30, 2019 09:48
CST Updated
09:48
AstraZeneca
Biopharmaceutical Manufacturer
MSD
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NICE
NICE is a non-departmental public body of the UK Department of Health, primarily responsible for: National Health Service, clinical practice of health technologies, guidelines for health promotion and disease prevention, and social care services. It serves the UK NHS.
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July 30, 2019 News /Bio ValleyBIOON/ -- UK pharmaceutical giantAstraZeneca(AstraZeneca) The targeted anticancer drug Lynparza (Chinese brand name: Lipuzhuo; generic name: olaparib, olaparib tablets) has recently received positive regulatory news in the United Kingdom. The National Institute for Health and Care Excellence (NICE) has issued final guidance approving Lynparza for use within the UK National Health Service (NHS) as a first-line maintenance therapy for patients with BRCA-mutated (BRCAm) advanced ovarian cancer who have achieved remission following first-line platinum-based chemotherapy. Specifically, this approval applies to patients with advanced (FIGO Stage III and IV) epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer harboring BRCA1/2 mutations.
NICE’s decision is based on the results of the pivotal Phase III clinical trial SOLO-1. The study results demonstrated that, compared with placebo, Lynparza achieved a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 70% (HR=0.30 [95% CI=0.23–0.41], p<0.001). At 41 months of follow-up, the median PFS had not been reached in the Lynparza treatment group, whereas it was 13.8 months in the placebo group. In the Lynparza treatment group, 60.4% of patients remained progression-free at 3 years, compared with 26.9% in the placebo group. In this study, the safety profile of Lynparza was consistent with that observed in previous studies.
The Royal MarsdenTumorDr. Susana Banerjee, Consultant Physician in Medical Oncology, Head of the ICR Gynaecological Cancer Group, and Co-Investigator of the SOLO-1 study, stated: “Maintenance therapy with Lynparza heralds a new era for patients with ovarian cancer. This is the first time we have seen such a significant improvement in progression-free survival. Landmark”Clinical Trial“SOLO-1 has transformed the treatment paradigm for women with advanced ovarian cancer. To date, study results have demonstrated that Lynparza maintenance therapy prolonged progression-free survival by approximately 3 years in patients with BRCA-mutated advanced ovarian cancer.”
Lynparza is a first-in-class, oral PARP inhibitor that preferentially kills cancer cells by exploiting defects in DNA repair pathways. This mechanism of action endows Lynparza with the potential to treat a broad range of tumors harboring DNA repair deficiencies. PARP is associated with a wide spectrum ofTumorType-related, especiallyBreast Cancerand ovarian cancer.
Lynparza is the first PARP inhibitor launched globally, initially approved in the United States in December 2014.FDAApproved for patients with advanced ovarian cancer harboring harmful or suspected harmful germline BRCA mutations (gBRCAm). To date, the drug has also been approved in more than 60 countries worldwide for maintenance treatment of platinum-sensitive recurrent ovarian cancer, regardless of BRCA status. Furthermore, it has been approved in the United States, Canada, Japan, and Australia for germline BRCA-mutated, HER2-negative metastatic breast cancer in patients who have previously received chemotherapy; in the European Union, this indication includes patients with locally advanced breast cancer.
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. Currently, both parties are conducting multiple clinical studies to investigate the use of Lynparza across a broad range ofTumorpotential, including breast cancer, prostate cancer, and pancreatic cancer. In ovarian cancer, both parties are advancing multiple studies, including the ongoing GINECO/ENGOT-ov25 Phase III study PAOLA-1, which is evaluating Lynparza in combination with Roche’s Avastin (bevacizumab) as first-line maintenance therapy for patients with advanced-stage (FIGO Stage III and IV) ovarian cancer, regardless of BRCA status. The results are expected to be announced in the second half of 2019.
In the Chinese market, Lynparza (olaparib) was approved by the China National Medical Products Administration (NMPA) on August 23, 2018, for maintenance treatment of platinum-sensitive recurrent ovarian cancer. This approval made Lynparza the first targeted therapy approved for ovarian cancer in China, marking the entry of PARP inhibitors into the era of ovarian cancer treatment in the country. (Bioon.com)