AstraZeneca's Lynparza (olaparib) has met its primary endpoint in the Phase III SOLO-2 clinical trial for the treatment of patients with germline BRCA-mutated (gBRCA), platinum-sensitive, relapsed ovarian cancer patients.
Lynparza is a first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor designed to target tumour DNA damage response (DDR) pathway deficiencies to potentially destroy cancer cells.
The trial's primary endpoint was measured as progression-free survival (PFS) by blinded independent central review (BICR) evaluation.
The randomised, double-blind, multi-centre Phase III trial evaluated the efficacy of Lynparza tablets as a maintenance monotherapy in 295 patients with documented germline BRCA1 or BRCA2 mutations who received at least two prior lines of platinum-based chemotherapy and were in complete or partial response.
AstraZeneca global medicines development executive vice-president and chief medical officer Sean Bohen said: “We are extremely pleased with the results from SOLO-2, which support the potential benefit of Lynparza tablets as a maintenance therapy for patients with relapsed ovarian cancer.
"The tablet formulation may offer patients a reduced pill burden for Lynparza and a safety profile that is generally consistent with previous trials.
"We will work with regulatory authorities to make Lynparza tablets available to patients as quickly as possible.”
A statistically significant benefit in time to second progression or death (PFS2), as well as improvements in other key secondary endpoints were also observed during the trial when compared to placebo.
The drug's safety profile was found to be consistent with the currently approved capsule formulation.
The trial was conducted in collaboration with the European Network for Gynaecological Oncological Trial Groups (ENGOT) and Groupe d’Investigateurs National pour l’Etude des Cancers de l’Ovaire et du sein (GINECO).