AstraZeneca’s Lynparza (ingredient: olaparib), the first PARP (poly ADP ribose polymerase) inhibitor, targets patients with a germline BRCA (breast cancer gene) mutation. Despite the limited target group, the drug has boosted the value of precision medicine in cancer types where treatment options were insufficient, an expert said.
After obtaining an indication for breast cancer in October, the company recently broadened Lynparza’s indication for the first-line maintenance therapy, in addition to the second-line maintenance therapy.
|Professor Im Seock-ah of the Hemato-Oncology Department at the Seoul National University Hospital speaks at a news conference on Wednesday.|
AstraZeneca Korea held a news conference on Lynparza’s extended indication and introduced the results of the studies on the treatment on Wednesday.
At the conference, Im Seock-ah, a professor at the Hemato-Oncology Department at the Seoul National University Hospital, said that Lynparza reduced the risk of death and progression by 42 percent, compared to the standard therapy, in metastatic breast cancer. She was the principal researcher of the OlympiAD trial, which supported the drug’s winning of indication for metastatic breast cancer.
“In particular, Lynparza proved its clinical value, superior to the chemotherapy, in patients with triple-negative metastatic breast cancer whose treatment options were very limited,” she said.
Results of the OlympiAD study showed that Lynparza lowered the risk of disease progression and death by 42 percent, compared to chemotherapy. The Lynparza group had a 59.9 percent response rate, more than twice that of the chemotherapy group at 28.8 percent.
The median progression-free survival (mPFS) of the Lynparza group was seven months, versus the chemotherapy group’s 4.2 months. The 12-month progression-free survival (PFS) was 25.9 percent in the Lynparza group, and 15 percent in the chemotherapy group. Overall survival, the second endpoint, did not show any significant difference between the two groups. However, in the subgroup of patients treated with olaparib without the chemotherapy at the stage of metastasized breast cancer, Lynparza improved the survival rate meaningfully, compared to the control group.
Im said as the expanded indication of Lynparza opened the possibility or precision medicine for patients with BRCA mutation in breast cancer, the government could expand the scope of reimbursement for BRCA tests so that more breast cancer patients could receive the optimal treatment.
Kim Byoung-gie, a pressor at the Obstetrics and Gynecology Department of Sungkyunkwan University School of Medicine, who authored the SOLO-1 study, introduced the maintenance therapy using Lynparza in ovarian cancer treatment.
“In the SOLO-1 study on advanced ovarian cancer patients at high risk of recurrence, the drug maintained its efficacy for nearly 41 months of treatment, without yielding median progression-free survival. This is an encouraging result of the drug that offered a new paradigm in ovarian cancer treatment,” Kim said.
According to Kim, Lynparza reduced the disease progression and mortality risk by 70 percent, compared to placebo, and the second disease progression and mortality risk by 50 percent.
The Lynparza group’s third-year PFS was 60 percent, more than double that of the placebo group at 27 percent. While the placebo group showed 13.8 months in median PFS, the median PFS of the Lynparza group did not come until 40.7 months of treatment.
Among Lynparza-treated patients, 12 percent discontinued the treatment, and 28 percent adjusted the treatment dose. The majority of adverse drug reactions improved with dose reduction and temporary treatment discontinuation. Most adverse events were grades 1 to 2, and the most common side effect in grade 3 and above was anemia.
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