Moving up the lines, AstraZeneca stakes another PhIII win for Lynparza as adjuvant breast cancer therapy
AstraZeneca and Merck are now fairly certain Lynparza works as an adjuvant therapy for BRCA-mutated high-risk HER2-negative early breast cancer.
That’s because the independent data monitoring committee for its Phase III OlympiA trial concluded that the PARP inhibitor crossed the superior boundary versus placebo for invasive disease-free survival — the main endpoint — and recommended that the companies stop the trial early and move to primary analysis now.
Together with its partners at Merck, the British pharma giant has carefully worked its way up lines of breast cancer treatments, first showing Lynparza can shrink or slow the growth of tumors in the metastatic setting.
The new trial suggests the benefits extend to early-stage patients who have had surgery as well as chemotherapy before or after it. In particular, it focused on women with mutations in the BRCA genes which, as OlympiA trial’s global chair Andrew Tutt noted, may also cause breast cancer to develop at a much earlier age than usual.
“The OlympiA trial has allowed us to go beyond using genetic testing to identify patients who are at risk of this disease and explore the potential of Lynparza to prevent disease recurrence for these patients,” he added in a statement.
AstraZeneca noted that the IDMC didn’t raise any new safety concerns. Investigators will continue to assess key secondary endpoints, including overall survival and distant disease-free survival.