AstraZeneca and Merck have secured approval from the European Commission (EC) for Lynparza (olaparib) as a first-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer.
With the approval, Lynparza can be used as a maintenance treatment for adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response following completion of 1st-line platinum-based chemotherapy.
Lynparza is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR) such as mutations in BRCA1 and/or BRCA2.
It is being assessed in a range of PARP-dependent tumour types with defects and dependencies in the DDR.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “This approval sets the stage for a new standard of care in the EU for women with ovarian cancer and a BRCA mutation.
“The goals of front-line therapy have always been long-term remission and even cure, yet currently 70% of patients relapse within three years of initial treatment.”
The approval was based on data from the phase III Solo-1 study, which assessed Lynparza as maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer following first-line platinum-based chemotherapy.
Solo-1 was a randomised, double-blinded, placebo-controlled and multi-centre trial that assessed the efficacy and safety of Lynparza tablets300mg twice daily) as a maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer following first-line platinum-based chemotherapy.
The study randomised 391 patients with a deleterious or suspected deleterious germline or somatic BRCA1 or BRCA2 mutation who have been in clinical complete or partial response.
As part of oncology collaboration with Merck and following the current approval, AstraZeneca will secure $30m (£23.9m) as ongoing collaboration revenue.
MSD Research Laboratories global clinical development head, chief medical officer and senior vice president Roy Baynes said: “In SOLO-1, Lynparza demonstrated clinically-meaningful results with a 70% reduction in the risk of disease progression or death in the first-line maintenance treatment of patients with BRCAm advanced ovarian cancer.”