A phase III trial has demonstrated that Lynparza maintenance therapy reduced risk of disease progression or death by 70% in patients with newly-diagnosed, advanced BRCA-mutated ovarian cancer.
The Phase III SOLO-1 trial assessed Lynparza as a maintenance treatment for patients with newly-diagnosed and advanced BRCA-mutated (BRCAm) ovarian cancer, who have been in complete or partial response following first-line standard platinum-based chemotherapy.
Lynparza is being jointly developed and commercialiszed by AstraZeneca and Merck.
The study showed statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for Lynparza compared against placebo and reduced the risk of disease progression or death by 70%.
AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “The remarkable results of the SOLO-1 trial, which showed that 60% of women with newly-diagnosed, advanced BRCA-mutated ovarian cancer remained progression-free at three years, highlight the potential of Lynparza as a maintenance therapy in the 1st-line setting.”
Both firms are also carrying out additional studies in ovarian cancer, including the ongoing Gineco/EngoTov25 phase III trial called Paola-1.
It is assessing the effect of Lynparza in combination with bevacizumab as a maintenance treatment for patients with newly-diagnosed advanced ovarian cancer, regardless of their BRCA status.
At present, Lynparza secured approval in more than 60 countries to treat platinum-sensitive relapsed ovarian cancer regardless of BRCA status.
Solo-1 is a phase III randomised, double-blinded, placebo-controlled and multicentre trial designed to assess the efficacy and safety of Lynparza tablets (300 mg twice daily) as maintenance monotherapy compared with placebo in newly-diagnosed patients with advanced BRCAm ovarian cancer following platinum-based chemotherapy.
The firm randomized 391 patients with a deleterious or suspected deleterious BRCA1 or BRCA2 mutation who were in clinical complete or partial response following platinum-based chemotherapy in the trial.
Lynparza, which is a first-in-class PARP inhibitor, is said to be the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies such as BRCA mutations to preferably kill cancer cells.
In July 2017, AstraZeneca collaborated with Merck to co-develop and co-commercialize Lynparza for multiple cancer types.
Merck Research Laboratories chief medical officer, global clinical development head and senior vice president Roy Baynes said: “Based on the SOLO-1 trial results, Lynparza is the only PARP inhibitor to have demonstrated a significant and clinically-meaningful improvement in reducing the risk of progression for newly-diagnosed patients with advanced BRCA-mutated ovarian cancer following platinum-based chemotherapy.”