AstraZeneca Lynparza shows clinically meaningful survival benefit in 1st-line advanced ovarian cancer across two Phase III trials

Both trials which were conducted in biomarker-selected, newly diagnosed patients with advanced ovarian cancer in the 1st-line maintenance setting also demonstrated a consistent safety profile.

The results for PAOLA-1 and SOLO-1 were presented on 9 September at the 2022 European Society of Medical Oncology (ESMO) and SOLO-1 results were published in Journal of Clinical Oncology.

Ovarian cancer is one of the most common gynaecologic cancers, with a poor prognosis and a high mortality rate. Over two thirds of patients are diagnosed with advanced disease, and approximately 50-70% of these patients die within five years. Up to one in five women with advanced ovarian cancer have a BRCA mutation, and roughly half of women have HRD-positive tumours (which includes those with a BRCA mutation).

Professor Isabelle Ray-Coquard, principal investigator from the PAOLA-1 trial and President of the Gineco group, said: "For women facing an advanced ovarian cancer diagnosis who are HRD-positive, a targeted treatment in the 1st-line maintenance setting is critical to helping them live longer. These latest results at the five-year landmark demonstrate that olaparib with bevacizumab reduces the risk of death by 38% in HRD-positive patients compared to bevacizumab alone, further reinforcing the clinically meaningful long-term survival benefit of this combination. This should be promising news for both clinicians and patients, as we see these additional data show that this combination may allow patients more time with family and loved ones. These results also highlight the importance of biomarker testing as part of a precision medicine approach to guide treatment decisions in ovarian cancer patients."

Professor Paul DiSilvestro, investigator from the SOLO-1 trial and Director of the Program in Women's Oncology at Women and Infants Hospital in Providence, Rhode Island, said: "The long-term results from SOLO-1 confirm that olaparib continues to elicit a clinically meaningful improvement in overall survival in the 1st-line maintenance setting for more than seven years. Achieving long-term survival for patients with newly diagnosed advanced ovarian cancer is critical because the 1st-line setting offers the greatest potential to impact patient survival."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "Historically the five year survival rate of newly diagnosed patients with advanced ovarian cancer is 30-50%. In that context, it is phenomenal to share the long term overall survival data from both PAOLA-1 and SOLO-1, with two out of three patients still alive in these trials. We continue to believe in Lynparza's ability to help biomarker-selected patients with advanced ovarian cancer to achieve better outcomes."

Dr Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, MSD Research Laboratories, said: "These latest data from the PAOLA-1 and SOLO-1 trials further highlight the importance of HRD testing, including for BRCA1/2 mutations, for all newly diagnosed advanced ovarian cancer patients at the point of diagnosis. Maintenance therapy with Lynparza may provide certain patients with HRD-positive and/or BRCA-mutated advanced ovarian cancer the opportunity to live longer."

Reference:

Paul DiSilvestro, Susana Banerjee, Nicoletta Colombo, Giovanni Scambia, Journal of Clinical Oncology, DOI: 10.1200/JCO.22.01549 Journal of Clinical Oncology