Lynparza (olaparib), a poly ADP-ribose polymerase (PARP) inhibitor, co-developed by AstraZeneca and Merck (known as MSD outside the US and Canada), has succeeded in a phase 3 trial held in patients with relapsed BRCA-mutated (BRCAm) advanced ovarian cancer by meeting the primary endpoint.
The SOLO-3 late-stage trial, which evaluated the efficacy and safety of Lynparza, featured 266 patients whose ovarian cancer relapsed following two or more lines of treatment.
Patients were randomly grouped in a 2:1 ratio in the trial to receive Lynparza 300mg tablets two times a day or physician’s choice single-agent chemotherapy (paclitaxel, topotecan, pegylated liposomal doxorubicin or gemcitabine).
Compared to chemotherapy, Lynparza was shown to have achieved a statistically-significant and clinically-meaningful improvement in both the primary endpoint of objective response rate (ORR) and the key secondary endpoint of progression-free survival (PFS).
Further, Lynparza’s safety and tolerability profile was found to be on par with preceding trials.
AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “We are very excited about SOLO-3, which is the first Phase III trial for a PARP inhibitor to demonstrate a positive result versus chemotherapy in advanced ovarian cancer where effective options are needed.”
SOLO-3 was carried out as a post-approval commitment as agreed by AstraZeneca and Merck with the US Food and Drug Administration (FDA).
Lynparza has been designed to preferentially eliminate cancer cells by exploiting DNA damage response (DDR) pathway deficiencies such as BRCA mutations.
MSD Research Laboratories global clinical development head, chief medical officer Roy Baynes said: “Following on the US approval of Lynparza as first-line maintenance therapy for certain patients with BRCAm advanced ovarian cancer, the results of SOLO-3 further reinforce the efficacy of Lynparza in relapsed patients with gBRCAm advanced ovarian cancer following multiple lines of chemotherapy.”
Lynparza’s approval as maintenance treatment for BRCAm advanced ovarian cancer was driven by the positive results from the phase 3 SOLO-1 trial.
In the late-stage trial, the PARP inhibitor was successful in cutting down the risk of disease progression or death by 70% in BRCAm advanced ovarian cancer patients who showed complete or partial response to platinum-based chemotherapy. This was in comparison to treatment with placebo following platinum-based chemotherapy.