AstraZeneca and Merck’s Lynparza has already led its class into two disease areas, and now it’s looking to make it three.
Tuesday, the companies said their PARP inhibitor had topped placebo at staving off progression of tough-to-treat pancreatic cancer in patients with germline BRCA-mutated forms of the disease. The phase 3 study, dubbed POLO, examined Lynparza in patients whose disease hadn’t worsened after an initial round of platinum-based chemo.
Full results from the study won’t roll out until a future medical meeting, but in the meantime, the pharma giants will be talking them over with regulators as soon as possible, José Baselga, AZ’s EVP of oncology R&D, said in a statement, calling pancreatic cancer “a devastating disease with critical unmet need.”
If the companies can eventually snag a green light, it will make Lynparza the first PARP drug to break into pancreatic cancer, which bears the worst survival rate among the most common cancers. The disease ranks as the fourth-leading cause of cancer death, and less than 7% of patients live for more than five years post-diagnosis, according to the companies. It affected 466,000 new patients around the world in 2018, and germline BRCA-mutated pancreatic cancer accounts for 5% to 7% of those patients, they said.
It wouldn’t be the first time Lynparza broke into a new therapy area on behalf of the PARP class. It was the first member to pick up an OK in ovarian cancer, where three of the four marketed PARP inhibitors got their start, and it’s gone on to win additional approvals in that field. And last year, it grabbed a go-ahead in germline BRCA-mutated breast cancer, another first for the field.
The result? The drug leads the PARP group, which also includes entrants from Clovis Oncology and GlaxoSmithKline’s Tesaro, in terms of total prescription volumes, AZ executives said recently, and in 2018, the drug’s revenue nearly doubled. Both AstraZeneca and Merck are counting on Lyparza’s revenues to keep them cruising in the oncology sales department.