AstraZeneca has reported positive findings from the Phase III SOLO-2 clinical trial of Lynparza (olaparib) to treat patients with germline BRCA-mutated (gBRCAm), platinum-sensitive, relapsed serous ovarian cancer.
Olaparib is an oral inhibitor of poly ADP-ribose polymerase (PARP) with the potential to target tumour DNA damage response (DDR) pathway deficiencies to destroy cancer cells.
Results from the randomised, double-blind, multi-centre Phase III trial indicated a sustained quality of life (QoL) and improved progression-free survival (PFS).
The trial evaluated the efficacy of 300mg twice-daily tablet dose of olaparib as a maintenance monotherapy in 295 women with documented germline BRCA1 or BRCA2 mutations.
The trial included subjects who had previously undergone treatment with a minimum of two lines of platinum-based chemotherapy and were in complete or partial response to their latest regimen.
AstraZeneca chief medical officer and global medicines development executive vice-president Sean Bohen said: “The olaparib QoL data further support the potential benefit of this first-in-class PARP inhibitor as maintenance therapy for women with BRCA-mutated relapsed serous ovarian cancer.
“They strengthen our confidence in targeting DNA damage response (DDR) mechanisms to selectively kill cancer cells while minimising damage to healthy tissue, which may cause adverse effects that impact negatively on quality of life for patients.”
Olaparib demonstrated a similar QoL outcome to placebo when assessed using functional, physical well-being and symptoms rating scales.
The results also showed significant quality-adjusted progression-free survival (QAPFS) and time without symptoms of disease or toxicity (TWiST) for around 27 months following randomisation.
The dose of the drug used in the trial potentially decreased the current pill burden from 16 capsules to four tablets per day, and the safety profile of the tablets was found to be consistent with currently approved capsule formulation.
Lynparza is also reported to minimise the risk of disease worsening or death during the randomised, open label, multi-centre Phase III OlympiAD trial conducted in 302 HER2-negative metastatic breast cancer patients with germline BRCA1 or BRCA2 mutations.