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▎The content team editor of WuXi AppTec today, AstraZeneca and Merck & Co.
(MSD) jointly announced that the PARP inhibitor olaparil (English trade name Lynparza) jointly developed by the two parties is used in the treatment of germline BRCA mutations (gBRCAm).
) Positive results were obtained in a phase 3 clinical trial of high-risk HER2-negative early breast cancer.
Olapali reduced the risk of disease recurrence, new tumor or death by 42% (HR=0.
58; 99.
5% CI: 0.
41-0.
82; p<0.
0001).
The Phase 3 clinical trial called OlympiA is a double-blind, placebo-controlled multicenter clinical trial.
Patients with high-risk HER2-negative early breast cancer who carry gBRCAm are randomized to receive olaparib or placebo after completing local treatment and neoadjuvant or adjuvant chemotherapy.
The primary endpoint of the trial is invasive disease-free survival (iDFS), which is defined as the time from randomization to the first local or remote disease recurrence, new tumor appearance, or death.
The results of the test showed that after 3 years of treatment, 85.
9% of patients in the olaparib group had no cancer recurrence or new cancer, compared with 77.
1% in the control group.
Olapali also reached the key secondary endpoint of distant-disease free survival (DDFS), reducing the risk of distant disease recurrence or death by 43%.
▲The efficacy results of olaparib in the Phase 3 clinical trial of OlympiA (picture source: reference [1]) In 2020, approximately 2.
3 million women worldwide will be diagnosed with breast cancer.
BRCA mutations occur in approximately 5% of breast cancer patients.
55-65% of women with BRCA1 gene mutations, and 45% of women with BRCA2 gene mutations will develop breast cancer before the age of 70.
90% of breast cancer patients are still in the early stage of the disease when they are diagnosed.
Therefore, how to prevent the disease from recurring after early surgical treatment is very important.
Olapali is a "first-in-class" PARP inhibitor jointly developed by AstraZeneca and Merck.
The drug targets the DNA damage repair response (DDR) pathway and uses the principle of "synthetic lethality" to kill cancer cells while reducing the impact on healthy cells.
It has been approved by the FDA to treat advanced ovarian cancer, breast cancer, pancreatic cancer and other cancer types that carry germline BRCA mutations.
Mr.
Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Department, said: “This is the first time that a drug targeting BRCA mutations has shown the potential to change the course of the disease in patients with early breast cancer, bringing hope for a cure.
We will work with regulatory agencies as soon as possible.
Bring Lynparza to these patients.
"Reference: [1] Lynparza reduced the risk of cancer recurrence by 42% in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer in OlympiA Phase III trial.
Retrieved June 3, 2021, from https:/ / -with-germline-brca-mutated-high-risk-early-breast-cancer-in-olympia-phase-iii-trial.
html Note: This article aims to introduce the progress of medical and health research, not a recommended treatment plan.
If you need to get treatment For program guidance, please go to a regular hospital for treatment.