Maintenance olaparib sustains PFS benefit in BRCA-mutated advanced ovarian cancer
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After a 5-year follow-up, almost half of patients with newly diagnosed BRCA-mutated advanced ovarian cancer were progression-free after receiving 2 years of maintenance olaparib, according to data presented at ESMO Virtual Congress 2020.
“Less than half of patients with newly diagnosed advanced ovarian cancer survive to 5 years, so the risk for relapse remains high. Despite treatment improvements, recurrent ovarian cancer remains typically uncurable,” Susana Banerjee, PhD, FRCP, of Royal Marsden Hospital NHS Foundation Trust and Institute of Cancer Research, London, U.K., said in her presentation.
Data from the SOLO1 trial, presented at ESMO 2018, demonstrated that maintenance olaparib (Lynparza; AstraZeneca, Merck) significantly reduced the risk for disease progression by 70% compared with placebo, according to Banerjee.
“What we are going to see now is the results from the March 2020 data cutoff, which took place 5 years after the last patient was randomized in SOLO1. This represents the longest follow-up for any PARP inhibitor trial in the newly diagnosed advanced ovarian cancer setting,” she said.
Researchers reported 5-year follow-up data on patients who received maintenance olaparib (tablets; 300 mg twice daily) or placebo for up to 2 years or until progression to determine PFS and recurrence-free survival.
Investigators randomly assigned 260 patients to receive olaparib and 131 to receive placebo (median treatment duration: 24.6 vs. 13.9 months).
Banerjee and colleagues found that PFS benefit of maintenance olaparib was sustained for 5 years. In the maintenance olaparib arm, median PFS was 56 months compared with 13.8 months in the placebo arm (HR = 0.33; 95% CI, 0.25-0.43), according to the presentation. This indicted a 67% reduction of risk for disease progression or death among women in the olaparib arm.
“The curves indicate that at 5 years, 48% of women in the olaparib arm were progression-free compared to 21%,” Banerjee said.
Moreover, patients in complete response at baseline had a 63% reduced risk for disease recurrence or death, according to the abstract.
Post-hoc analysis to determine recurrence-free survival in patients who achieved complete response to chemotherapy indicated that 52% of patients in the maintenance olaparib arm remained free from relapse 5 years later compared with 22% of those in the placebo arm, according to Banerjee.
Secondary efficacy outcomes also supported the observed PFS benefit, Banerjee said. Further, maintenance olaparib at 5 years had a safety profile similar to that reported in the primary analysis, with no new safety signals or concerns, and no new cases of MDS/AML.
“The substantial benefits of maintenance olaparib continued beyond the end of treatment and with 2 years of treatment, median progression-free survival is over 4 and a half years,” Banerjee concluded. “These results provide further evidence to support the use of maintenance olaparib as a standard of care for women with newly diagnosed BRCA-mutated advanced ovarian cancer. It raises the possibility of achieving long-term remission and even cure for some patients.”
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Banerjee S, et al. Abstract 811MO. Presented at: European Society for Medical Oncology Virtual Congress 2020; Sept. 19-21, 2020.
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