Lynparza reduced the risk of cancer recurrence by 42% in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer in OlympiA Phase III trial.-AstraZeneca + Merck Inc.

The results will be presented during the plenary session of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting on 6 June 2021 (abstract LBA#1) and were published today in The New England Journal of Medicine. An estimated 2.3 million people were diagnosed with breast cancer worldwide in 2020 and BRCA mutations are found in approximately 5% of breast cancer patients. In the overall trial population of patients who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy, results showed Lynparza reduced the risk of invasive breast cancer recurrences, second cancers or death by 42% (based on a hazard ratio [HR] of 0.58; 99.5% confidence interval [CI] 0.41-0.82; 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. lynparza also demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of distant disease-free survival (ddfs) in the overall trial population. lynparza reduced the risk of distant disease recurrence or death by 43% (based on an hr of 0.57; 99.5% ci 0.39-0.83; p><0.0001). at the time of this initial data cut-off, fewer deaths had occurred in patients receiving lynparza, but the difference in overall survival (os) did not reach statistical significance. the trial will continue to assess os as a secondary endpoint. the safety and tolerability profile of lynparza in this trial was in line with that observed in prior clinical trials. the most common adverse events (aes) were nausea (57%), fatigue (40%), anaemia (23%) and vomiting (23%). grade 3 or higher aes were anaemia (9%), neutropenia (5%), leukopenia (3%), fatigue (2%), and nausea (1%). approximately 10% of patients treated with lynparza discontinued treatment early due to aes. olympia is a global collaborative phase iii trial coordinated by the breast international group (big) worldwide, in partnership with nrg oncology, the us national cancer institute (nci), frontier science & technology research foundation (fstrf), astrazeneca and msd. the trial is sponsored by nrg oncology in the us and by astrazeneca outside the us. brca1 and brca2 are human genes that produce proteins responsible for repairing damaged dna and play an important role maintaining the genetic stability of cells. when either of these genes is mutated or altered such that its protein product either is not made or does not function correctly, dna damage may not be repaired properly, and cells become unstable. as a result, cells are more likely to develop additional genetic alterations that can lead to cancer and confer sensitivity to parp inhibitors including lynparza. andrew tutt, chair of the olympia trial steering committee and professor of oncology at the institute of cancer research, london and kings college london, said: “we are thrilled that our global academic and industry partnership in olympia has been able to help identify a possible new treatment option for patients with early-stage breast cancer and who have inherited mutations in their brca1 or brca2 genes. patients with early-stage breast cancer who have inherited brca mutations are typically diagnosed at a younger age compared to those without such a mutation. olaparib has the potential to be used as a follow-on to all the standard initial breast cancer treatments to reduce the rate of life-threatening recurrence and cancer spread for many patients identified through genetic testing to have mutations in these genes.” see-"adjuvant olaparib for patients with brca1- or brca2-mutated breast cancer"-andrew n.j. tutt, m.b., ch.b., ph.d., judy e. garber, m.d., m.p.h., bella kaufman, m.d., giuseppe viale, m.d.,et al., for the olympia clinical trial steering committee and investigators.-june 3, 2021 doi: 10.1056 nejmoa2105215.></0.0001).></0.0001).>