AstraZeneca and Merck's Lynparza Meets Primary Endpoint in Phase III OlympiA Trial for Adjuvant Treatment of High-Risk Early Breast Cancer with gBRCA Mutations

February 19, 2021 News /BioValleyBIOON/ --AstraZeneca(AstraZeneca) and its partner Merck & Co. recently jointly announced that, based on the recommendation of the Independent Data Monitoring Committee (IDMC), an evaluation was conducted on the targeted anticancer drug Lynparza (Chinese brand name: Lipuzhuo; generic name: olaparib, olaparib tablets) as adjuvant therapy for high-risk HER2-negative early-stage BRCA-mutatedBreast CancerThe OlympiA phase 3 trial will transition to early primary analysis and reporting.

Based on the planned interim analysis, the IDMC concluded that,The trial crossed the superiority boundary for the primary endpoint of invasive disease-free survival (iDFS), demonstrating sustained, clinically relevant treatment benefits with Lynparza versus placebo in patients with germline BRCA mutations (gBRCAm) and high-risk HER2-negative early breast cancer.

The IDMC recommends conducting the primary analysis now.The IDMC did not raise any new safety concerns during the communication, and the trial will continue to evaluate the key secondary endpoints of overall survival (OS) and distant disease-free survival.

OlympiA is a double-blind, parallel-group, placebo-controlled, multicenter Phase 3 trial designed to evaluate the efficacy and safety of Lynparza tablets versus placebo as adjuvant therapy in patients with germline BRCA-mutated (gBRCAm), high-risk, HER2-negative early breast cancer who have completed local treatment and neoadjuvant or adjuvant chemotherapy. The primary endpoint of the trial is invasive disease-free survival (iDFS), defined as the time from randomization to the first occurrence of treatment failure (local or distant recurrence, new primary cancer, or death from any cause).

It is estimated that in 2020, 2.3 million women worldwide wereDiagnosisIn breast cancer, BRCA mutations are found in approximately 5% of patients. Approximately 55–65% of women with BRCA1 mutations and about 45% of women with BRCA2 mutations will develop breast cancer before the age of 70.

Roy Baynes, Senior Vice President of Merck Research Laboratories and Global Head of Clinical Development, as well as Chief Medical Officer, stated: “Based on the recommendations of the IDMC, the analysis of the OlympiA trial may represent a potential advancement for patients with early-stage high-risk primary breast cancer harboring germline BRCA mutations.”

Lynparza is a first-in-class, oral poly(ADP-ribose) polymerase (PARP) inhibitor that selectively kills cancer cells by exploiting defects in the tumor DNA damage repair (DDR) pathway. This mechanism of action enables Lynparza to treat a broad range of cancers with DNA damage repair deficiencies, such as BRCA1 and/or BRCA2 mutations.Tumorpotential.

In July 2017, AstraZeneca and MSD reached a global strategic collaboration in oncology to jointly develop and commercialize Lynparza and another MEK inhibitor, selumetinib, for the treatment of a broad range ofTumor, including breast cancer, prostate cancer, and pancreatic cancer.

Lynparza is the first PARP inhibitor to be marketed globally, receiving its initial approval in the United States in December 2014.FDAApproved. To date, Lynparza has been approved for seven therapeutic indications: (1) first-line maintenance treatment of adult patients with BRCA-mutated advanced ovarian cancer; (2) first-line maintenance treatment in combination with bevacizumab for adult patients with HRD-positive advanced ovarian cancer; (3) maintenance treatment of adult patients with recurrent ovarian cancer; (4) treatment of adult patients with advanced gBRCA-mutated ovarian cancer; (5) treatment of adult patients with gBRCA-mutated, HER2-negative (HER2-) metastatic breast cancer; (6) first-line maintenance treatment of adult patients with gBRCA-mutated metastatic pancreatic cancer; (7) treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) harboring specific gene mutations.

In China, Lynparza (olaparib) was approved in August 2018 for maintenance treatment of platinum-sensitive recurrent ovarian cancer. Lynparza is the first targeted therapy approved for the treatment of ovarian cancer in the Chinese market, marking the entry of ovarian cancer treatment in China into the era of PARP inhibitors.

In early December 2019, Lynparza (olaparib) received renewed approval 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: IDMC has concluded that the OlympiA trial of Lynparza crossed the superiority boundary for invasive disease-free survival vs. placebo at the planned interim analysis