When used as a first-line therapy to treat newly diagnosed women with advanced ovarian cancer who previously responded to platinum-based chemotherapy, Lynparza (olaparib) prolonged the time they lived without showing signs of disease progression compared to a placebo, according to five-year data from a Phase 3 trial.
Lynparza is an anti-cancer therapy jointly developed by AstraZeneca and Merck (known as MSD outside the U.S. and Canada) that has been approved for the treatment of advanced ovarian cancer, pancreatic cancer, and certain types of breast cancer.
The medication works by blocking an enzyme called PARP, which plays an essential role in DNA repair, and cancer cell growth and survival. Lynparza is particularly effective in patients who carry genetic mutations in BRCA genes, which are also involved in DNA repair.
It was approved as a first-line maintenance therapy for women with advanced ovarian cancer whose tumors contained BRCA mutations in the U.S., Europe, Japan, China, and other countries. The approvals were based on data from the Phase 3 SOLO-1 trial.
SOLO-1 assessed the efficacy and safety of Lynparza in 391 women with either inherited or acquired BRCA mutations, who had high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, and responded to first-line platinum-based chemotherapy.
During the study, patients were randomly assigned to receive either 300 mg of Lynparza or a placebo, twice daily, for up to two years, or until disease progression.
The trial’s main goal was to determine if Lynparza could be superior to a placebo at prolonging the time women lived without worsening.
This goal was met after 36 months (three years) of follow-up, when 61% of the patients who received Lynparza were alive and without signs of disease progression, while 27% of those given a placebo achieved the same outcome.
The companies now presented updated five-year data from SOLO-1, which showed Lynparza prolonged the time these women lived without worsening from a median of 13.8 to 56 months, lowering the risk of death or disease progression by 67% compared to the placebo.
After five years, nearly half (48.3%) of the patients who received Lynparza continued showing no signs of disease progression, compared with 20.5% of those given the placebo. In addition, Lynparza also lowered the risk of disease recurrence by 63%.
“For patients with newly-diagnosed BRCA-mutated advanced ovarian cancer, the benefit derived from two years of maintenance treatment with Lynparza continued long after treatment ended,” Susana Banerjee, MD, PhD, consultant medical oncologist at The Royal Marsden NHS Foundation Trust, and one of the investigators of SOLO-1, said in a press release.
“After five years, almost half of women were free of cancer progression,” she added. “These results represent a significant step forward in the treatment of BRCA-mutated advanced ovarian cancer.”
Lynparza’s safety profile during the study was consistent with previous reports. The most common adverse events observed during the trial included nausea (77%), fatigue (63%), vomiting (40%), anemia (39%), and diarrhea (34%). A total of 12% of patients on Lynparza discontinued treatment due to an adverse event.
“Once a patient’s ovarian cancer recurs, it historically has been incurable,” José Baselga, MD, PhD, executive vice president at AstraZeneca, said. “Even at an advanced stage, we have shown that maintenance treatment with Lynparza can help patients achieve sustained remission.”
“Today’s results further underline the critical importance of identifying a patient’s biomarker status at the time of diagnosis to offer a treatment that may help delay disease progression,” he added.