Clinical trial findings show that olaparib, given in the neoadjuvant setting, was feasible with 100% of participants able to receive the planned 2 cycles.
Administering poly (ADP-ribose) polymerase inhibitors (PARPi) olaparib (Lynparza) from AstraZeneca prior to chemotherapy and surgical intervention resulted in favorable surgical options, manageable adverse events, and positive health outcomes for individuals with ovarian cancer with germline mutation, according to results from the Neoadjuvant Olaparib Window (NOW) (NCT03943173) trial.1
The findings demonstrated that olaparib, given in the neoadjuvant setting, was feasible with 100% of individuals in the trial able to receive the planned 2 cycles. Approximately 93% of individuals were able to undergo subsequent surgery, with all achieving optimal tumor reduction.1
Among those who were treated with 2 cycles of Olaparib, followed by surgery and adjuvant computerized tomography scan, 85% had no evidence of disease after the completion of all therapies.1
“Patients are interested in receiving therapies specifically targeting their tumor,” Shannon Westin, MD, MPH, an investigator, said in a statement. “There was great excitement among patients for the opportunity to not receive chemotherapy.”1
Adverse events (AEs) during treatment with olaparib were similar to what investigators expected, including abdominal pain, anemia, constipation, nausea, and pain. The only severe AE reported was grade 3 anemia in 3 individuals.1
The NOW trial was a open-label, single-arm pilot study for advanced-stage, high-grade epithelial ovarian, peritoneal, or fallopian tube carcinoma. All individuals had a germline mutation in BRCA1, BRCA2, PALB2, or RAD51C.1
There were 15 total individuals treated, with a median age of 56 years. Approximately 40% of individuals had stage 4 disease.1
“This study provides a potential template for how we might vet targeted therapies earlier in the treatment continuum,” Westin said. “As drug options increase, it is encouraging to see opportunities for patients to get testing at diagnosis and receive targeted therapy in lieu of or in addition to chemotherapy.”1
Historically, PARPi usage followed cytotoxic chemotherapy as a maintenance medication, which has been taken long-term among individuals with ovarian cancer.1
the findings justify further research to see if PARPi can be given to individuals who receive chemotherapy in the neoadjuvant setting, which would be a new usage of this medication, investigators said.1
Results of the trial were presented at the Society of Gynecologic Oncology 2023 Annual Meeting on Women’s Cancer.1
FDA-approved Olaparib is indicated for breast, ovarian, pancreatic, and prostate cancer. It is also approved as an add-on therapy to different treatments or a monotherapy.2
1. Study finds intriguing outcomes in ovarian cancer patients treated with PARP inhibitors before surgical intervention and subsequent chemotherapy. Society of Gynecologic Oncology. News release. March 25, 2023. Email.
2. Lynparza label. Prescribing information. AstraZeneca. 2022. Accessed March 27, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s023lbl.pdf