AstraZeneca and Merck’s PARP inhibitor Lynparza has scored FDA approval as a maintenance therapy for pancreatic cancer – a notoriously hard-to-treat cancer.
Lynparza has been cleared as a first-line maintenance therapy for BRCA-mutated, advanced pancreatic cancer that has not progressed on platinum-based chemotherapy.
The approval was based on results from the phase 3 POLO trial of Lynparza (olaparib) in advanced BRCA-mutated pancreatic cancer patients, which demonstrated impressive progression free survival rates of 7.4 months, almost double the 3.8 months achieved in the placebo arm.
The PARP inhibitor also decreased the risk of disease worsening or death by 47% in the study, which was an impressive feat considering the aggressive nature of pancreatic cancer.
Around 5% to 6% of pancreatic cancers are caused by mutations in or or both BRCA genes, which are more often associated with ovarian and breast cancer but are seen in a number of tumour types.
One caveat to the study was that Lynparza was unable to beat placebo in terms of the overall survival rate. An interim analysis on approximately half of the trial population showed that those on the Lynparza survived for a median of 18.9 months compared to 18.1 months in the placebo group.
In an FDA briefing document, the medicines authority noted “that while the trial may have been inadequately sized to detect small differences in survival, it was of adequate size and power to detect an effect on survival that is similar to that claimed for PFS.”
However, it seems that the PFS data, coupled with the very limited treatment options for this indication, swayed the FDA advisory committee, who ultimately voted seven to five in favour of the drug. This narrow approval reflects the concerns outlined in the briefing document, particularly around the OS rate.
“We are pleased with the ODAC’s recommendation for Lynparza and the potential to bring a personalised, biomarker-targeted medicine to patients with germline BRCA-mutated metastatic pancreatic cancer,” said José Baselga (pictured left), executive vice president, oncology R&D
“Patients with advanced pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and limited treatment advances over the last few decades,” he added.
The approval in pancreatic cancer is Lynparza’s third indication, alongside ovarian and breast cancer.
The PARP inhibitor has grown fast, and is one of AZ’s new cancer drugs driving its return to revenue growth over the past few financial quarters.
Lynparza is also under regulatory review for BRCA-mutated pancreatic cancer in the EU and Canada, among others.