The final overall survival results of the PAOLA-1/ENGOT-ov25 trial confirmed the drug combination as “one of the standards of care” for some populations of patients with ovarian cancer.
Maintenance Lynparza (olaparib), when added to Avastin (bevacizumab), resulted in benefits in overall and progression-free survival for patients with newly diagnosed, advanced ovarian cancer, according to the final overall survival results of the PAOLA-1/ENGOT-ov25 trial.
The results, published in the journal Annals of Oncology on May 19, showed that at a median follow-up of 61.7 and 61.9 months for patients treated with Lynparza and Avastin or Avastin and a placebo, the median overall survival (time from treatment until death of any cause) was 56.5 versus 51.6 months among the intention-to-treat (ITT) population.
Among the Lynparza group, 19.6% received subsequent PARP inhibitor therapy, compared with 45.7% of placebo patients. For participants who were homologous recombination deficiency (HRD)-positive, Lynparza resulted in a five-year overall survival rate of 65.5%, versus 48.4% for the placebo group. The five-year progression-free survival rate (the time a patient lives without the disease worsening) was 46.1% without relapse for patients treated with Lynparza and 19.2% for patients treated with placebo.
“The addition of maintenance (Lynparza) to (Avastin) modestly numerically prolonged (overall survival) versus (Avastin) alone in patients with newly diagnosed advanced ovarian cancer (ITT population),” the authors wrote. “However, in the subset of patients with HRD-positive tumors, where PARP inhibitors are expected to be biologically active, (Lynparza) plus (Avastin) provided a clinically meaningful, numerical (overall survival) advantage at five years, despite 50% of patients in the control arm receiving PARP inhibitors after progression.
“Updated (progression-free survival) data reinforce the (progression-free survival) advantage of this first-line maintenance combination in patients with HRD-positive tumors, which previously led to wide approval, and demonstrate that the advantage is maintained at five years. Taken together, these results confirm the addition of (Lynparza) to (Avastin) as one of the standards of care for patients with HRD-positive tumors in this setting and highlight the importance of precision medicine and biomarker testing to guide treatment decisions in newly diagnosed advanced ovarian cancer patients.”
The phase 3 PAOLA-1/ENGOT-ov25 trial launched in 2015 as the first phase 3 trial to examine a PARP inhibitor’s efficacy and safety with Avastin when used as a first-line maintenance therapy for patients with ovarian cancer regardless of BRCA mutation status. Its 806 participants, who had stage 3 or 4 ovarian cancer, were randomized 2:1 to receive 300 mg of Lynparza twice daily for up to 24 months plus 15 mg/kg of Avastin every three weeks for 15 months, or a placebo plus Avastin.
Trial results presented at the European Society of Medical Oncology Congress 2019 in Barcelona, showed a median progression-free survival time of 22.1 months for the Lynparza group and 16.6 months for the placebo group.
It was reported this January that maintenance Lynparza plus Avastin appeared to result in higher progression-free survival among patients with BRCA-mutant, high-grade ovarian cancer, followed by the news in April that Lynparza and Imfinzi (durvalumab) added to Avastin and chemotherapy was shown to be likely to improve outcomes for patients with advanced, high-grade epithelial ovarian cancer without BRCA mutations.
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