Lynparza Now Approved as Maintenance Therapy for BRCA-Mutated Metastatic Pancreatic Cancer

On December 27, 2019, the FDA approved a new indication for olaparib (Lynparza; AstraZeneca), for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. The FDA also approved the BRACAnalysis CDx test (Myriad Genetics) as a companion diagnostic to select patients with pancreatic cancer who are candidates for treatment with olaparib based on the identification of deleterious or suspected deleterious germline mutations in BRCA1 or BRCA2 genes.

This new indication was based on results of the POLO study, a double-blind, multicenter, phase 3 clinical trial of patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic cancer.

A total of 154 patients who had received at least 16 weeks of platinum-based chemotherapy were randomized in a 3:2 ratio to receive olaparib 300 mg twice daily or placebo.

The primary efficacy end point was progression-free survival (PFS) by blinded independent central review. Median PFS was 7.4 months in the olaparib arm versus 3.8 months in the placebo arm (hazard ratio, 0.53; 95% confidence interval, 0.35-0.81; P = .0035), which was a statistically significant and clinically meaningful improvement in PFS.

“Today’s approval of olaparib based on the POLO results gives clinicians an important first-line maintenance treatment option which nearly doubled the progression-free survival benefit in patients with germline BRCA-mutated metastatic pancreatic cancer,” said Hedy L. Kindler, MD, lead investigator and Professor, Medicine, University of Chicago, IL, in a press statement.

The most common adverse reactions (≥10%) with olaparib were fatigue/asthenia (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%).

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