AZ/Merck & Co’s Lynparza POLO Study ‘Practice Changing’ For Pancreatic Cancer Subgroup
A near doubling of progression-free survival in the POLO study of AstraZeneca/Merck & Co’s Lynparza could usher in a new era of targeted therapy for metastatic pancreatic patients with germline BRCA mutations, and open up a third indication for the leading PARP inhibitor.
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US FDA usually recommends using overall survival for pancreatic cancer drugs, but AstraZeneca chose progression-free survival; now ODAC will weigh in on whether the PARP inhibitor olaparib demonstrated a clinically meaningful impact. The firm cites enrollment and design challenges in the gBRCAm population as reasons for using PFS.
AstraZeneca and Merck seek to add a pancreatic cancer indication for olaparib, while Merck has hopes of broadening pembrolizumab’s use in bladder cancer; two-day Oncologic Drugs Advisory Committee meeting also will include reviews of Celgene’s luspatercept in myelodysplastic syndromes-related anemia and Epizyme’s tazemetostat for epithelioid sarcoma.