Results from the phase III SOLO-2 trial have been released, demonstrating a significant improvement in progression-free survival (PFS) in germline BRCA-mutated (gBRCA), platinum-sensitive, relapsed ovarian cancer patients treated with olaparib tablets (300mg twice daily), compared with placebo in the maintenance setting.
The trial met its primary endpoint of investigator-assessed PFS (HR 0.30; 95% CI 0.22-0.41; P<0.0001; median 19.1 months vs 5.5 months).
These results, presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer in National Harbor, Maryland, build upon prior data in this setting, demonstrating the potential of olaparib as a maintenance therapy in relapsed ovarian cancer.
Olaparib is currently available in the UK for patients with BRCAm ovarian cancer who have relapsed following platinum based chemotherapy.
Richard Penson, MD, Associate Professor of Medicine at Harvard Medical School and Clinical Director of Medical Gynecologic Oncology at Massachusetts General Hospital said “The SOLO-2 data demonstrated a statistically significant and clinically meaningful improvement in outcomes for those who took olaparib. The results, which showed a delay in disease progression in the maintenance setting, highlight the impact of PARP inhibition at the forefront of the important advances we are making in targeting ovarian cancer.”
PFS as measured by Blinded Independent Central Review (BICR) evaluation, a pre-specified sensitivity analysis supporting the primary endpoint, demonstrated a median PFS of 30.2 months vs 5.5 months for placebo, representing an improvement of 24.7 months (HR 0.25; 95% CI 0.18-0.35; P<0.0001).
Additionally, a statistically-significant benefit in time to second progression or death (PFS2) was also seen in patients treated with olaparib (HR 0.50; 95% CI 0.34-0.72; P=0.0002; median not reached vs 18.4 months), compared with placebo, as well as improvements in other key secondary endpoints.
Any adverse events (AE) Grade ≥3 were reported in 36.9% of patients treated with LYNPARZA and in 18.2% of patients who received placebo.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “We are extremely pleased with the results from SOLO-2, which support the potential benefit of olaparib as a maintenance therapy for patients with relapsed ovarian cancer. The tablet formulation may offer patients a reduced pill burden for olaparib and a safety profile that is generally consistent with previous trials. We will work with regulatory authorities to make olaparib tablets available to patients as quickly as possible.”
(27 Mar 2017)