Lynparza (olaparib), AstraZeneca’s PARP (poly ADP-ribose polymerase) inhibitor, has won approval as the primary treatment for high-risk early-stage breast cancer and metastatic, castration-resistant prostate cancer.
Last Thursday, the Ministry of Food and Drug Safety approved Lynparza as adjuvant therapy for gBRCA-mutated HER2-negative high-risk early-stage breast cancer and as combination therapy for metastatic castration-resistant prostate cancer with abiraterone and prednisolone.
By adding new indications, Lynparza has expanded its treatment scope to gBRCA-mutated HER2-negative early breast cancer and metastatic prostate cancer regardless of the genetic mutation using PARP inhibitors in addition to the existing indication of HER2-negative metastatic breast cancer and BRCA-mutated metastatic castration-resistant prostate cancer with disease progress records after new hormone treatment previously.
The approval was based on the OlympiA study in the case of gBRCA-mutated HER2-negative high-risk early-phase breast cancer patients and the PROpel study in the case of metastatic castration-resistant prostate cancer patients receiving primary treatment.
In the interim analysis of the phase 3 OlympiA clinical trial, Lynparza improved the overall survival (OS) of patients with gBRCA-mutated HER2-negative, high-risk early-stage breast cancer patients for the first time as a PARP inhibitor.
As a postoperative adjuvant therapy for HER2-negative high-risk early-stage breast cancer patients, Lynparza reduced invasive progression and death risk by 42 percent compared to a placebo. It also reduced death risk by 32 percent during the tracking period of a median value of 3.5 years, confirming the significant improvement in OS.
In phase 3 clinical trial of the PROpel study, Lynparza also proved its efficacy and safety as a primary treatment regardless of heterogeneous recombinant recovery (HRR) genetic mutation.
The combination therapy of Lynparza and abiraterone significantly extended radiological progression-free survival (rPFS) to 24.8 months compared to 16.6 months for abiraterone + placebo combo therapy while lowering disease progression and death risks by 34 percent.
Although the survival rate of early-phase breast cancer has improved due to the development of treatment, patients with high-risk clinical and pathological characteristics have had high recurrence risks, requiring more positive treatments. Besides, the survival period for metastatic castration-resistant prostate cancer has been less than 12 months amid limited treatments available.
“Through Lynparza, we have come to deliver a treatment option that can prevent the recurrence of patients and prolong their survival in HER2-negative high-risk early-stage breast cancer and metastatic castration-resistant prostate cancer with great unmet demands,” said Yang Mi-seon, executive director for the anticancer business department. “We will do our best to deliver better treatment options who have been alienated due to the lack of options through the continuous development of our first PARP inhibitor, Lynparza.”
At the same time, Lynparza has indications for ovarian cancer such as; primary maintenance therapy for newly diagnosed progressive BRCA-mutated highly epithelial ovarian, fallopian tube, or primary peritoneal cancer patients as monotherapy; maintenance therapy for adults with secondary or higher recurrent highly epithelial ovarian cancer (including ovarian or primary peritoneal cancer) as monotherapy; and, as combo therapy with bevacizumab (product name: Avastin), primary maintenance therapy for adult patients with HRD-positive highly epithelial ovarian, fallopian tube, or primary peritoneal cancer.