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AstraZeneca and MSD's Lynparza crosses superiority boundary for invasive disease-free survival

Published on 17/02/21 at 10:22am

The OlympiA Phase III trial for AstraZeneca and MSD’s cancer drug Lynparza will move to early primary analysis and reporting, following a recommendation from the Independent Data Monitoring Committee (IDMC).

Based on the planned interim analysis, the IDMC concluded that the trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) and demonstrated a sustainable, clinically relevant treatment effect for Lynparza versus placebo for patients with germline BRCA-mutated (gBRCAm), high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. The committee recommends that primary analysis now take place.

Lynparza’s Phase III trial is a partnership between Breast International Group, NRG Oncology, the US National Cancer Institute, Frontier Science & Technology Research Foundation, AstraZeneca, and MSD. The trial is sponsored by NRG Oncology in the US and by AstraZeneca outside the US.

An estimated 2.3 million women were diagnosed with breast cancer worldwide in last year, and BRCA mutations are found in approximately 5% of all breast cancer patients. Around 55% to 65% of women with a BRCA1 mutation, and approximately 45% with a BRCA2 mutation, will develop breast cancer before the age of 70.

Roy Baynes, Senior Vice President and Head of Global Clinical Development, and Chief Medical Officer at MSD Research Laboratories, commented: “Analysis of the OlympiA trial, based upon the IDMC recommendation, could represent a potential step forward for patients with early-stage, high-risk primary breast cancer with a germline BRCA mutation.”

Andrew Tutt, Global Chair of the OlympiA Phase III trial and Professor at the Institute of Cancer Research and Kings College London, also said: “We are delighted that our global academic and industry partnership has been able to help investigate a possible personalised treatment for women with hereditary breast cancer. The most common cause of hereditary breast cancer is an inherited mutation in the BRCA1 or BRCA2 genes which also may cause the disease to develop at a significantly earlier age than is usual.

“The OlympiA trial has allowed us to go beyond using genetic testing to identify patients who are at risk of this disease and explore the potential of Lynparza to prevent disease recurrence for these patients.”

Darcy Jimenez

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