Olaparib plus bevacizumab benefits beyond first progression in high‐grade ovarian carcinoma
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Adding maintenance olaparib to bevacizumab provided a benefit beyond first progression, with a substantial second progression-free survival benefit, in patients with newly diagnosed, advanced high-grade ovarian carcinoma, according to data presented at ESMO Virtual Congress 2020.
Previous data from the PAOLA1/ENGOT-ov25 trial demonstrated that the addition of maintenance olaparib (Lynparza; AstraZeneca, Merck) with bevacizumab (Avastin, Genentech) provided a significant progression-free survival benefit compared with bevacizumab alone, with a 41% reduction in the rate of disease progression or death, among women with advanced ovarian cancer, Antonio González-Martín, MD, co-director of the department of oncology at Navarre University Hospital, Madrid, Spain, said in his presentation.
“PFS2, defined as the time from randomization to second progression or death, was immature at the time of the primary PFS analysis. Today, we present the final PFS2 analysis in the intent-to-treat population as well as post-hoc analysis by biomarker status,” González-Martín said.
Investigators randomly assigned patients with newly diagnosed stage III-IV high-grade ovarian carcinoma (HGOC) in response after platinum-based chemotherapy plus bevacizumab to receive olaparib tablets (300 mg twice daily for 24 months) plus bevacizumab (15 mg/kg every 3 weeks for 15 months) or placebo plus bevacizumab. The researchers examined PFS2 and time to second subsequent therapy or death (TSST) as key secondary endpoints.
Overall, 537 patients received olaparib plus bevacizumab and 269 received placebo plus bevacizumab over a median PFS2 follow-up of 35.5 and 36.5 months.
Analysis indicated that olaparib plus bevacizumab provided a statistically significant decrease in the risk for second progression or death compared with placebo plus bevacizumab (HR = 0.78; 95% CI, 0.64 -0.95).
By biomarker status, olaparib plus bevacizumab also provided a statistically significant decrease in the risk for PFS2 compared with placebo plus bevacizumab in patients with a BRCA mutation (HR = 0.53), in HRD-positive patients (HR = 0.56) and in HRD-positive patients without a BRCA mutation (HR = 0.6), according to the abstract.
The investigators reported time to second subsequent therapy was longer with olaparib plus bevacizumab compared with placebo plus bevacizumab (median 38.2 vs. 31.5 months; HR = 0.78;[95% CI, 0.64 -0.95) and no new safety signals with longer follow-up.
“To conclude, the initial PFS improvement seen with olaparib plus bevacizumab was sustained beyond first progression,” González-Martín said. “Olaparib plus bevacizumab provided a substantial PFS2 benefit in women who were HRD-positive, regardless of BRCA-mutation status. Overall survival data are still immature.”
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Gonzalez-Martin A, et al. Abstract LBA33. Presented at: European Society for Medical Oncology Virtual Congress 2020; Sept. 19-21, 2020.
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