Therapy Areas: Cardiovascular
AstraZeneca and Merck announce Lynparza trial shows 70% reduction in PFS ovarian cancer
23 October 2018 -

AstraZeneca Plc (LSE:AZN), a global, science-led biopharmaceutical company and global pharmaceutical company Merck & Co Inc (NYSE:MRK) (known as MSD outside the US and Canada) announced on Monday detailed results from the phase III SOLO-1 trial testing Lynparza (olaparib) tablets as a maintenance treatment for patients with newly-diagnosed, advanced BRCA-mutated (BRCAm) ovarian cancer, who were in complete or partial response following first-line standard platinum-based chemotherapy.

Reportedly, results of the trial confirm the statistically-significant and clinically -meaningful improvement in progression-free survival (PFS) for Lynparza compared to placebo, reducing the risk of disease progression or death by 70%. At 41 months of follow-up, the median PFS for patients treated with Lynparza was not reached, as compared to 13.8 months for patients treated with placebo. Also, of those receiving Lynparza, 60% remained progression-free at 36 months compared to 27% of women in the placebo arm.

This data were presented at the Presidential Symposium of the ESMO 2018 Congress (European Society for Medical Oncology) in Munich, Germany and published simultaneously online in the New England Journal of Medicine(NEJM).

Currently, Lynparza is approved in over 60 countries for the treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status and in the US, Canada, Japan and Australia for germline BRCA-mutated HER2-negative metastatic breast cancer.

SOLO-1 is a phase III randomised, double-blinded, placebo-controlled, multicentre trial to evaluate 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. This trial randomised 391 patients with a deleterious or suspected deleterious BRCA1 or BRCA2 mutation who were in clinical complete or partial response following platinum-based chemotherapy.

The primary endpoint was PFS and key secondary endpoints included time to second disease progression or death, time to first subsequent treatment and overall survival.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, is approved for advanced ovarian cancer and metastatic breast cancer and has been used in over 20,000 patients worldwide.

In July 2017, AstraZeneca and Merck & Co had announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world's first PARP inhibitor and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types.

AstraZeneca is focussed on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.

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