- British pharma Astrazeneca on Wednesday revealed its cancer drug Lynparza (olaparib) extended progression-free survival (PFS) compared to placebo among patients with BRCA-mutated relapsed ovarian cancer.
- While detailed data isn't available, AstraZeneca said the statistically significant improvement in median PFS seen in the Phase 3 trial exceeded the 11.2 months (versus 4.3 months for placebo) recorded from a previous Phase 2 study.
- AstraZeneca hopes to win approval for Lynparza as a maintenance monotherapy for BRCA-mutated ovarian cancer, setting up a showdown with Tesaro's rival PARP inhibitor, known as niraparib.
AstraZeneca's seemingly strong results likely set up a battle among the rival PARP inhibitors currently moving through late-stage development.
Earlier this year, Tesaro's niraparib met its primary endpoint in a Phase 3 trials, extending median PFS by almost 16 months compared to placebo. Tesaro's stock promptly doubled and the company hopes to line up a regulatory submission to the Food and Drug Administration before the end of 2016.
Elsewhere, Clovis Oncology has filed its rucaparib for accelerated approval, and has a PDUFA date of February 23.
Yet the SOLO-2 results have left AstraZeneca confident in Lynparza's profile.
"We will work with regulatory authorities to make Lynparza tablets available as quickly as possible to patients with ovarian cancer," said Sean Bohen, head of global medicines development at AstraZeneca.
The results follow a fast track designation granted to Lynparza by the FDA earlier this year in patients with a BRCA mutation who have platinum-sensitive, relapsed ovarian cancer. Lynparza is already available in the U.S. for use in heavily pretreated patients. Its success in Phase 3 could put it in a good position for an expanded approval.
Lynparza hasn't seen success across the board, however. In May, a Phase 3 trial showed Lynparza failed to improve overall survival in advanced gastric cancer. While the drug has been approved in Europe for relapsed ovarian cancer, it has been rejected for funding by NHS Scotland and England's NICE —a decision which raised the ire of CEO Pascal Soriot.
Lynparza is part of AstraZeneca's DNA damage-response (DDR) research program, and is also in clinical trials for adjuvant therapy in breast cancer, treatment of metastatic breast cancer and treatment of pancreatic cancer, with filings planned between 2017 and 2020.