AstraZeneca reports Lynparza PFS benefit vs. placebo during ESMO presentation

AstraZeneca (AZN) and Merck's (MRK) Lynparza demonstrated a long-term progression-free survival, or PFS, benefit versus placebo as a 1st-line maintenance treatment in patients with newly diagnosed, advanced BRCA-mutated, or BRCAm, ovarian cancer who had a complete or partial response following platinum-based chemotherapy. Five-year follow-up data from the SOLO-1 Phase III trial showed Lynparza reduced the risk of disease progression or death by 67% and improved PFS to a median of 56 months versus 13.8 months for placebo. At five years, 48.3% of patients treated with Lynparza remained free from disease progression versus 20.5% on placebo. The median duration of treatment with Lynparza was 24.6 months versus 13.9 months with placebo. The safety profile of Lynparza was consistent with previous observations. The most common adverse events, or AEs, greater than or equal to 20% were nausea, fatigue/asthenia, vomiting, anaemia and diarrhoea. The most common greater than or equal to grade 3 AEs were anaemia and neutropenia. Overall, 12% of patients on Lynparza discontinued treatment due to an AE. The results were presented on during the 2020 European Society of Medical Oncology, or ESMO, virtual congress. The SOLO-1 Phase III trial met the primary endpoint of PFS in June 2018, which formed the basis of approvals in the US, the EU, Japan, China and several other countries.