Bharti Jayshankar
December 13, 2024: AstraZeneca and Merck have announced long-term results from the OlympiA Phase 3 trial, showing that Lynparza (olaparib) significantly improves overall survival in patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.
The trial key findings show that 87.5% of patients treated with Lynparza were alive at six years compared to 83.2% in the placebo group.
Lynparza reduced the risk of death by 28% and demonstrated sustained improvements in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS).
Importance of germline BRCA testing
Judy E. Garber, co-principal investigator of the trial, emphasized the significance of germline BRCA testing at diagnosis. She said, “These data reinforce the importance of germline BRCA testing at the time of diagnosis, so we can identify all eligible patients who may benefit from treatment with olaparib as early as possible.”
Breast cancer treatment
Breast cancer remains a significant health challenge, with approximately 2.3 million new cases diagnosed globally in 2022. About 5-10% of these patients have BRCA mutations, making the findings from the OlympiA trial particularly relevant.
Susan Galbraith from AstraZeneca noted that Lynparza’s continued efficacy after two years reinforces its role as a transformative treatment option for patients with this aggressive form of breast cancer.
Trial safety and efficacy results
The safety and tolerability of Lynparza in the OlympiA trial were consistent with previous studies. Here is a list of some outcomes and results that emerged during extended follow-up.
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) occurred in approximately 1.2% of patients treated with Lynparza, which is comparable to other cancer treatments that also carry risks for these conditions.
Pneumonitis was reported in 0.8% of patients, with some cases being fatal. This risk is similar to that seen in other targeted therapies.
Venous thromboembolism (VTE) was noted in 8% of patients receiving Lynparza, higher than the 2.5% observed in control groups. This highlights a potential concern shared with various cancer treatments.
In the OlympiA trial, 87.5% of patients treated with Lynparza were alive at six years, compared to 83.2% in the placebo group. This makes it the first and only PARP inhibitor to show a survival benefit in early breast cancer.
Lynparza reduced the risk of invasive breast cancer recurrence by 35%, with a hazard ratio (HR) of 0.65. This indicates a significant improvement over standard treatments.
Similar results were seen in disease-free survival, where Lynpara also reduced the risk by 35% (HR 0.65).
Comparison with other PARP inhibitors
While other PARP inhibitors, such as niraparib and rucaparib, have shown efficacy in various cancers, including ovarian cancer and prostate cancer, Lynparza stands out for its specific application in early-stage breast cancer with BRCA mutations.
The results from the OlympiA trial highlight Lynparza as a vital option for those facing high-risk early breast cancer. With ongoing research and clinical trials, there is hope for improved outcomes for patients diagnosed with this challenging disease.
The results were presented at the 2024 San Antonio Breast Cancer Symposium and also published in The New England Journal of Medicine.
