AstraZeneca and Merck claim Japanese approval for anti-cancer drug Lynparza
20 June 2019
AstraZeneca and Merck & Co, a subsidiary of New Jersey, US-based Merck Sharp & Dohme Corp, on Wednesday said their anti-cancer drug Lynparza (olaparib) has been approved in Japan as a maintenance treatment after first-line chemotherapy in patients with advanced ovarian cancer, as detected by an approved companion diagnostic test.
The approval by the Japanese ministry of health, labour and welfare was based on data from the pivotal Phase III 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, the companies stated in a release.
“The goals of front-line therapy are long-term remission or a cure, yet currently 70 per cent 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 transform patient outcomes.” Dave Fredrickson, executive vice president, Oncology Business Unit, said.
Results for the SOLO-1 trial announced in October 2018 showed at 40.7 months of follow-up the median time of progression for patients treated with Lynparza had not yet been reached vs 13.8 months for those on placebo, the release said, adding Lynparza is the only PARP inhibitor approved in Japan.
AstraZeneca and MSD are 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.
The Japanese approval follows European Commission marketing authorisation announced in June 2019. Interactions with regulatory authorities in the rest of the world are ongoing, the companies stated.
Patients were randomised (2:1) to receive Lynparza or placebo for up to two years or until disease progression. 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 (PFS) and key secondary endpoints included time to second disease progression or death, time to first subsequent treatment and overall survival.
The data were presented on 21 October 2018, at the Presidential Symposium of the ESMO 2018 Congress in Munich, Germany and published simultaneously online in The New England Journal of Medicine.