Phase 3 SOLO1 Subgroup Analysis Based on Olaparib-Treated, Low- and High-Risk Patients with Ovarian Cancer and BRCA Mutation

2020 Year in Review - Ovarian Cancer - Ovarian Cancer

In patients with newly diagnosed, advanced ovarian cancer and BRCA mutation, olaparib demonstrated a consistently high reduction in the risk for cancer progression and death.

Patients with a BRCA mutation and newly diagnosed, advanced ovarian cancer who received maintenance therapy with olaparib had significantly improved progression-free survival (PFS) when compared with placebo in the phase 3 SOLO1 study.1

At the European Society of Gynaecological Oncology 2020 Virtual Conference, Nicoletta Colombo and colleagues presented an exploratory analysis from higher-risk and lower-risk subgroups. For up to 2 years or until disease progression, participants received olaparib 300 mg twice daily or placebo. Patients in the higher-risk group had been diagnosed with stage IV disease, stage III disease with residual disease following primary debulking surgery, inoperable stage III disease, or had stage III disease and underwent interval surgery. Patients in the lower-risk group had been diagnosed with stage III disease without residual disease following primary debulking surgery. Response to treatment and PFS were evaluated.

A total of 391 patients were included in the analysis; 44% were lower risk and 56% were higher risk. After a median follow-up of approximately 41 months, the risk for disease progression or death was significantly reduced with olaparib compared with placebo in the higher-risk group (66% reduction) and the lower-risk group (67% reduction). Patients in the higher-risk group experienced a median PFS of 39.0 months compared with 11.1 months in the olaparib and placebo treatment arms, respectively. In the lower-risk group, median PFS was not reached in the olaparib arm compared with 21.9 months in the placebo arm. Similar patterns were seen in the assessment by the blinded independent central reviewers.

The investigators concluded that this exploratory analysis of data from the SOLO1 study reveals maintenance therapy with olaparib provided a considerable PFS benefit when compared with placebo in both higher- and lower-risk patients who have been newly diagnosed with advanced ovarian cancer and have a BRCA mutation. They emphasized that this study highlights important findings in the larger environment of research in this area, as it demonstrates a significant reduction in the risk for cancer progression and death in both higher-risk and lower-risk patients with newly diagnosed advanced ovarian cancer.

Source: Colombo N, et al. Int J Gynecol Cancer. 2020;30(4_suppl). Abstract 392.

Reference
1. Moore K, Colombo N, Scambia G, et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2018;379:2495-2505.

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Last modified: January 20, 2021