AstraZeneca presented positive results from its Phase III OlympiAD trial for patients treated with Lynparza (olaparib) tablets compared to treatment with physician’s choice of a standard of care chemotherapy.
The trial also showed that patients treated with Lynparzahad a 42 percent reduction in risk of their disease worsening or death, ( 7 vs 4.2 months) compared to those who received chemotherapy. The findings were presented at a conference in Chicago.
Mark E. Robson, clinic director of the Clinical Genetics Service at Memorial Sloan-Kettering Cancer Center, New York and Principal Investigator of OlympiAD said, “The OlympiAD data presented today demonstrate the benefit of olaparib in delaying the progression of advanced BRCA-mutated breast cancer. With few alternatives available, a targeted non-chemotherapy oral treatment in this setting could be a beneficial new option for patients.”
Sean Bohen, executive vice president, Global Medicines Development, and Chief Medical Officer at AstraZeneca, said, “The OlympiAD results shared today to mark the first time a targeted therapy shows benefit over the current standard of care for patients with HER2-negative gBRCA-mutated metastatic breast cancer. This also represents an important milestone for Lynparza as this is the first positive Phase III trial in which a PARP inhibitor has shown a significant benefit for patients outside of ovarian cancer.”
A review of the Lynparza safety data from the OlympiAD trial did not identify any new safety signals and the overall safety profile was consistent with previous trials of Lynparza.
Lynparza tablets are an investigational formulation and are not FDA-approved for any use.
Lynparza capsules (400 mg twice daily) are currently approved in the US for some patients with advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.
Continued approval may be contingent upon verification and description of clinical benefit in other trials.
