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news.A phase 3 clinical trial evaluating AstraZeneca's PARP inhibitor Lynparza (olaparib) as maintenance therapy in ovarian cancer demonstrated a pronounced extension in survival compared to placebo.
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The trial established that the drug had significantly improved the progression-free survival (PFS) in ovarian cancer patients with germline BRCA-mutations (gBRCA) whose disease had relapsed, and had also failed to respond to platinum-based chemotherapy.
Patients were treated with 300mg of Lynparza tablets, taken twice daily during the trial. The oral poly ADP-ribose polymerase (PARP) inhibitor, Lynparza was studied as a maintenance monotherapy against placebo in the randomised, double-blind, multicentre phase 3 trial dubbed SOLO-2.
AstraZeneca chief medical officer and global medicines development executive vice president Sean Bohen said that the phase 3 results backed Lynparza’s potential benefit as a maintenance treatment for patients with relapsed ovarian cancer.
Bohen added: “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.”
AstraZeneca stated that Lynparza had cut down the risk of disease progression by 70% while increasing PFS to 19.1 months in comparison to placebo’s 5.5 months.
The company said a PFS of 30.2 months was noted in comparison to placebo’s 5.5 months going by the blinded independent central review.
The Phase III SOLO-2 trial also showed statistically-considerable benefit in time to second progression or death (PFS2) among patients subjected to Lynparza along with improvements in other important secondary endpoints, when compared to the patient group treated with placebo.
AstraZeneca added further that Lynparza tablets in line with prior studies had demonstrated a safety profile. There was also a low incidence of haematological toxicity noted in the treatment with Lynparza as per AstraZeneca.
Lynparza’s mechanism is to exploit tumour DNA damage response (DDR) pathway deficiencies to selectively destroy cancer cells. The drug has approvals in Europe and the US for the treatment of BRCAm ovarian cancer in women.