AstraZeneca-MSD PARP inhibitor to set new benchmark in early breast cancer therapy

Pharma News: According to new research presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, the addition of 1 year of AstraZeneca and MSD’s PARP inhibitor Lynparza (olaparib) after completion of standard neoadjuvant or adjuvant therapy, significantly improved invasive disease-free (IDFS) and distant disease-free survival (DDFS).

The OlympiA trial is the first phase III study to report the effect of a PARP inhibitor in any adjuvant setting and in this context is focused on patients with germline BRCA1 or BRCA2 mutations and early-stage, high-recurrence risk breast cancer, following completion of standard multi-modality therapy, which includes a combination of chemotherapy drugs.

ASCO President, Dr Lori J. Pierce, stated “OlympiA’s findings highlight the need for genetic testing for BRCA mutations in patients diagnosed with high-risk early-stage breast cancer. These results could have an important impact on treatment decisions for this patient population, possibly including the use of a PARP inhibitor in the adjuvant setting.”

In the OlympiA study, the addition of Lynparza to standard therapy reduced the risk of invasive breast cancer recurrences, second cancers or death by 42% (p<0.0001). At three years, 85.9% of patients treated with Lynparza remained alive and free of invasive breast cancer and second cancers versus 77.1% on placebo.

While 3-year estimated overall survival (OS) was greater with Lynparza, the difference was not statistically significant at the time of this interim analysis at 2.5 years median follow up. 

“The OlympiA study results, the first reporting the effects of a PARP inhibitor as an “adjuvant therapy” on survival endpoints, suggest a possible addition to the standard of care for patients with germline BRCA1/2 mutation-associated early breast cancer who have levels of recurrence risk requiring neoadjuvant or adjuvant chemotherapy” said lead author Professor Andrew Tutt, MB ChB, PhD, FMedSci who is the Head of the Division of Breast Cancer Research and Director of the Breast Cancer Now Toby Robins Research Centre at the Institute of Cancer Research, London and the Breast Cancer Now Research Unit at Guy’s Hospital King’s College London.

Dave Fredrickson, Executive Vice President, Oncology Business Unit at AstraZeneca, said “This is the first time that any medicine targeting a BRCA mutation has demonstrated the potential to change the course of early-stage breast cancer and offer hope for a cure. By providing a treatment which significantly reduces the risk of breast cancer returning in these high-risk patients, we hope Lynparza will set a new benchmark demonstrating sustained clinical benefit. We are working with regulatory authorities to bring Lynparza to these patients as quickly as possible.”