Lynparza approved in Japan for 1st-line

19 June 2019 07:00 BST

Lynparza approved in Japan for 1st-line maintenance
therapy in BRCA-mutated advanced ovarian cancer

60% of patients receiving Lynparza remained free of disease progression
after three years vs. 27% receiving placebo in pivotal Phase III SOLO-1 trial

AstraZeneca and MSD's Lynparza is the only PARP inhibitor approved in Japan

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been approved in Japan as a maintenance treatment after 1st-line chemotherapy in patients with BRCA-mutated (BRCAm) 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 1st-line platinum-based chemotherapy.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "This approval in Japan is a critical advance for women with ovarian cancer and a BRCA mutation. The goals of front-line therapy are long-term remission or a 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 transform patient outcomes."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: "Advances in understanding the role of BRCA mutations and PARP inhibition have fundamentally changed how physicians can treat this aggressive type of cancer. With the approval of this new indication, patients in Japan with BRCA-mutated advanced ovarian cancer who respond to chemotherapy will have the opportunity to benefit from Lynparza in the 1st-line maintenance setting."

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 (HR 0.30 [95% CI, 0.23-0.41], p< 0.001).

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 1st-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.

About SOLO-1
SOLO-1 was a Phase III, randomised, double-blinded, placebo-controlled, multi-centre trial to evaluate the efficacy and safety of Lynparza tablets (300mg twice daily) 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 (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. 

Please refer the PDF to view the full announcement.

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