AstraZeneca and MSD have presented full results from the Phase III SOLO3 trial which compared Lynparza (olaparib) with physician’s choice of chemotherapy in the treatment of patients with germline BRCA1/2-mutated (gBRCAm) advanced ovarian cancer who had received two or more prior lines of chemotherapy.
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 (ORR) for Lynparza vs. chemotherapy. ORR measures the proportion of patients with reduction in tumour burden of a predefined percentage.
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 (13.4 months) vs. chemotherapy.
José Baselga, Executive Vice President, 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. We look forward to working closely with regulatory authorities to include findings from this trial in the prescribing information for Lynparza.”
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “Lynparza is the first and only PARP inhibitor to demonstrate efficacy versus chemotherapy in relapsed BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. The positive SOLO3 results reaffirm AstraZeneca and MSD’s ongoing commitment to explore potential treatment options beyond standard of care for BRCA-mutated with advanced stage disease.”