AstraZeneca secures another European indication for 'Lynparza'

AstraZeneca and its partner MSD announced on Tuesday that the European Commission (EC) has approved ‘Lynparza’ (olaparib) as a first-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer.

The FTSE 100 pharmaceuticals giant said the licensed indication was as a maintenance treatment of adult patients with advanced - FIGO stages III and IV - BRCA1/2-mutated - germline or somatic - high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, who were in complete or partial response following completion of 1st-line platinum-based chemotherapy.

“This approval sets the stage for a new standard of care in the EU for women with ovarian cancer and a BRCA mutation,” said Dave Fredrickson, executive vice-president of AstraZeneca’s oncology business unit.

“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 progression-free survival benefit of Lynparza observed in SOLO-1 represents a major step forward in our ambition to help transform patient outcomes.”

Roy Baynes, senior vice-president and head of global clinical development, and chief medical officer at MSD Research Laboratories, added that in the SOLO-1 trial, 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.

“[MSD] and AstraZeneca are committed to improving outcomes for people with cancer and we will work to bring this new option to women in the EU, many of whom have historically poor outcomes, as quickly as possible,” Baynes said.

The companies said the EC approval was based on data from the pivotal phase 3 SOLO-1 trial, which tested Lynparza as maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer following first-line platinum-based chemotherapy.

Results announced in October last year at 40.7 months of follow-up showed the median time of progression for patients treated with Lynparza had not yet been reached, compared to 13.8 months for those on placebo.

It was the third indication for Lynparza in the EU, with AstraZeneca and MSD said to be exploring additional trials in ovarian cancer, including the ongoing Phase III PAOLA-1 trial, which is testing Lynparza in combination with bevacizumab as a first-line maintenance treatment for women with newly-diagnosed, advanced, stage IIIB-IV high grade serous or endometrioid ovarian cancer, regardless of BRCA status.

AstraZeneca described SOLO-1 as a phase 3, randomised, double-blinded, placebo-controlled, multi-centre trial to evaluate the efficacy and safety of 300mg twice daily Lynparza tablets as a maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer, following first-line platinum-based chemotherapy.

The trial randomised 391 patients with a deleterious or suspected deleterious germline or somatic BRCA1 or BRCA2 mutation, who were in clinical complete or partial response following platinum-based chemotherapy.

Patients were randomised to receive Lynparza or placebo for up to two years or until disease progression.

AstraZeneca said patients who had a partial response at two years were permitted to stay on therapy at the investigator's discretion.

The primary endpoint was progression-free survival, with key secondary endpoints, including time to second disease progression or death, time to first subsequent treatment and overall survival.