Lynparza recommended for approval in the EU by CHMP as adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer
First PARP inhibitor to improve overall survival in early-stage breast cancer
AstraZeneca and MSD's Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm) who have HER2-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the OlympiA Phase III trial published in The New England Journal of Medicine in June 2021.1
In the trial, Lynparzademonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% versus placebo (based on a hazard ratio [HR] of 0.58; 99.5% confidence interval [CI] 0.41-0.82; p<0.0001).
Lynparza also demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), reducing the risk of death by 32% versus placebo (based on a HR of 0.68; 98.5% CI 0.47-0.97; p=0.009). The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials.
Breast cancer is the most diagnosed cancer worldwide with an estimated 2.3 million patients diagnosed in 2020.2 Approximately 90% of all breast cancer patients are diagnosed with early breast cancer.4,5 In Europe, BRCA mutations are found in up to 10% of patients.6
Professor Andrew Tutt, Global Chair of the OlympiA Phase III trial and Professor of Oncology at The Institute of Cancer Research, London and King's College London, said: “For patients with high-risk, early-stage breast cancer, the risk of recurrence remains unacceptably high and cancer will return for more than one in four of these patients. Today's recommendation is hopeful news for patients in Europe, as we move closer to setting a potential new standard of care that improves overall survival in patients suitable for treatment with olaparib.”
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “If approved, Lynparza will become a new targeted treatment option for patients with germline BRCA-mutated HER2-negative early breast cancer in Europe. By treating patients with curative-intent as early as possible in their disease, we hope to avoid life-threatening recurrence and give people more time with their loved ones.”
Dr. Eliav Barr, Head of Global Clinical Development and Chief Medical Officer, MSD Research Laboratories, said: “Patients with germline BRCA-mutated HER2-negative early breast cancer will often develop breast cancer at an earlier age than those without BRCA mutations, impacting people in their prime. Today's announcement brings us closer to our goal of offering a much-needed new treatment option to these patients.”
In March 2022, Lynparza was approved in the US for the treatment of gBRCAm, HER2-negative high-risk early breast cancer. Lynparza is also approved in the US, EU, Japan and many other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial. In the EU, this indication also includes patients with locally advanced breast cancer.