AstraZeneca could be looking at earlier use of its PARP inhibitor Lynparza in breast cancer, thanks to a new clinical trial win.
When used after surgical removal of tumors, Lynparza topped placebo at fending off invasive disease and preventing death among patients with BRCA-mutated, high-risk, HER2-negative early breast cancer, AstraZeneca said Wednesday.
An independent data monitoring committee said the phase 3 OlympiA trial had crossed the superiority bar for that primary endpoint and recommended investigators start analyzing specific data. And that means AstraZeneca could report the so-called “invasive disease-free survival” data earlier than expected, the company said.
AZ said last week that it was expecting to take the OlympiA data to regulators in the second half of this year.
The trial will continue to follow patients for secondary endpoints, such as Lynparza’s ability to prevent distant disease recurrence and—more importantly—whether it can help patients live longer.
In BRCA-mutated HER2-negative breast cancer, Lynparza’s already approved to treat patients with metastatic disease who’ve previously received chemotherapy—either before or after surgery—to prevent cancer from returning or as treatment for active disease.
If Lynparza eventually gets an FDA go-ahead based on OlympiA, it would be able to help patients with earlier-stage tumors in patients after surgery—otherwise known as the adjuvant setting.
Lynparza, which AstraZeneca markets in collaboration with Merck & Co., is so far the market leader in the PARP inhibitor class, mainly thanks to its larger ovarian cancer indications.
In 2020, sales of Lynparza jumped 48% year over year to reach $1.78 billion. GlaxoSmithKline’s Zejula, Clovis Oncology’s Rubraca and Pfizer’s Talzenna came nowhere near Lynparza in terms of sales.
Aside from adjuvant breast cancer, AZ this year also expects to read out data from the phase 3 PROpel trial, which tests Lynparza plus Johnson & Johnson’s Zytiga against solo Zytiga in previously untreated metastatic castration-resistant prostate cancer.