Merck (MSD) and AstraZeneca have reported that Lynparza (olaparib) mitigated the risk of invasive recurrences in patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer in the Phase III OlympiA trial.
A poly (ADP-ribose) polymerase (PARP) inhibitor, Lynparza is the first targeted drug to hinder DNA damage response in cells or tumours with a deficiency in homologous recombination repair, such as in BRCA1 and/or BRCA2 mutations.
In July 2017, AstraZeneca and Merck entered a global strategic oncology partnership to co-develop and co-commercialise Lynparza, which has so far been used to treat more than 40,000 patients globally.
The double-blind, placebo-controlled, multi-centre Phase III OlympiA trial analysed the efficacy and safety of Lynparza tablets compared to placebo as an adjuvant treatment.
It involved gBRCAm, high-risk, HER2-negative early breast cancer patients who have received definitive local therapy and neoadjuvant or adjuvant chemotherapy.
Data from the trial demonstrated that Lynparza showed statistically significant progress in its primary goal of invasive disease-free survival when compared to placebo.
The drug lowered the risk of recurrences of invasive breast cancer, second cancers, or death by 42%.
The drug also showed statistically significant and clinically meaningful progress in a key secondary goal of distant disease-free survival.
Furthermore, fewer deaths occurred in patients receiving Lynparza during the preliminary data cut-off, but the difference in overall survival (OS) failed to reach statistical significance.
The trial is continuing to evaluate OS as a secondary endpoint.
Lynparza’s safety and tolerability profile in the trial was consistent with that noted in previous clinical trials.
Merck Research Laboratories chief medical officer and Global Clinical Development senior vice-president and head Roy Baynes said: “These new data support the importance of testing at diagnosis for BRCA1/2 mutations, which are actionable biomarkers that can help identify patients with early breast cancer who may be eligible for adjuvant treatment with Lynparza.
“Testing for BRCA mutations in addition to hormone receptor status and the expression of the HER2 protein will allow clinicians to better inform potential treatment plans for their patients.”
Last month, Merck reported that its 15-valent pneumococcal conjugate vaccine candidate, V114, met the primary immunogenicity and safety goals in two Phase III paediatric clinical trials, PNEU-DIRECTION and PNEU-PLAN.