AstraZeneca and MSD have shared positive results for Lynparza (olaparib) in previously treated germline BRCA1/2-mutated (gBRCAm) advanced ovarian cancer.
The results from the trial, presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US, showed a statistically-significant and clinically-meaningful improvement in objective response rate for Lynparza vs. chemotherapy in the indication.
In ovarian cancer, the treatment achieved a 72% objective response rate in patients with the relapsed, germline BRCA-mutated variation of the disease who had received two or more prior lines of chemotherapy, making it the first and only PARP inhibitor to demonstrate efficacy vs. chemotherapy.
The trial also met the key secondary endpoint of progression-free survival (PFS), demonstrating a statistically-significant and clinically-meaningful improvement in the time patients lived without disease progression for Lynparza of 13.4 months vs. 9.2 months on chemotherapy.
The news comes hot on the heels of the company’s announcement that the drug improved the time without disease progression in pancreatic cancer by a median of 7.4 months, and that 22% of patients receiving the monotherapy remained free of disease progression after two years vs. 10% on placebo.
José Baselga, vice president of oncology R&D, said: “Lynparza provides a much-needed alternative and improvement over standard-of-care chemotherapy for patients with BRCA-mutated, advanced ovarian cancer. This is the fourth positive Phase II/III trial in advanced ovarian cancer for Lynparza, across multiple lines of therapy. We look forward to working closely with regulatory authorities to include findings from this trial in the prescribing information for Lynparza.”
Advanced ovarian cancer means the cancer has spread to other body organs some distance away from the ovaries, such as the liver or lungs. Incidence rates for ovarian cancer are projected to rise by 15% in the UK between 2014 and 2035, to 32 cases per 100,000 females by 2035.