Highlights from

ESMO 2019

European Society for Medical Oncology Congress 2019

Barcelona 27 September - 01 October 2019

Ovarian cancer patients benefit from combined maintenance therapy

Prof. Isabelle Ray-Coquard (Université Claude Bernard, Lyon, France) presented the late-breaking results of the PAOLA-1/ENGOT-ov25 trial showing a benefit in progression-free survival when adding the PARP inhibitor olaparib to bevacizumab treatment, in an all-comers ovarian cancer population, irrespective of BRCA mutation [1].

PAOLA-1/ENGOT-ov25 is the first phase 3 trial to examine the efficacy and safety of a pharmacological inhibitor of the enzyme poly-ADP ribose polymerase (PARP) with bevacizumab as first-line maintenance therapy in patients in women with newly-diagnosed advanced ovarian cancer who had a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab, with and without a BRCA mutation. This international, academic-led trial enrolled 806 patients. After completing first-line chemotherapy, patients were randomly allocated 2:1 to olaparib or placebo, in addition to the standard of care, bevacizumab monotherapy. They received olaparib for up to 24 months and bevacizumab for 15 months in total. The primary outcome was investigator-assessed progression-free survival.

The median follow-up was 24 months in the olaparib arm and 22.7 months in the placebo arm. Median progression free survival was 22.1 months in the olaparib group and 16.6 months in the placebo group (HR 0.59; 95% CI 0.49-0.72; P<0.0001). In prespecified subgroup analyses, the progression-free survival benefit of olaparib versus placebo was even more pronounced in patients with a BRCA mutation and in those with homologous recombination deficiency (HRD), with hazard ratios of 0.31 and 0.33, respectively. Median progression-free survival with olaparib reached 37.2 months in patients with a BRCA mutation and in patients with HRD. Prof. Ray-Coquard noted that randomisation in PAOLA-1/ENGOT-ov25 started a median 6 weeks after the last cycle of chemotherapy, whereas most previous trials started randomisation with the first cycle of chemotherapy. "It is an important point to consider when comparing the results to other data," she said.

  1. Ray-Coquard IL et al. Phase III PAOLA-1/ENGOT-ov25 trial: Olaparib plus bevacizumab (bev) as maintenance therapy in patients (prs) with newly diagnosed, advanced ovarian cancer (OC) treated with platinum-based chemotherapy (PCh) plus bev. ESMO Congress 2019, 27 Sept-1 October 2019, Barcelona, Catalonia, Spain, Abstract LBA2


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