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Bevacizumab Addition Boosts Niraparib PFS For Platinum-Sensitive Recurrent Ovarian Cancer

Combining niraparib and bevacizumab extends survival for women with platinum-sensitive recurrent ovarian cancer
06 Sep 2019
Ovarian Cancer;  Anticancer Agents
By Lynda Williams, Senior medwireNews Reporter

medwireNews: Phase II trial results suggest that the addition of bevacizumab to niraparib significantly extends progression-free survival (PFS) for patients with platinum-sensitive, recurrent ovarian cancer. 

The AVANOVA2/ENGOT-ov24 study included patients with high-grade serous or endometrioid platinum-sensitive recurrent disease who had received at least first-line platinum-based chemotherapy but no more than one non-platinum-containing regimen for recurrent disease. 

After a median 16.9 months of follow-up, median PFS was 11.9 months for the 48 women who were randomly assigned to receive the oral PARP inhibitor niraparib 300 mg/day plus intravenous bevacizumab 15 mg/kg every 3 weeks. 

This was significantly longer than the 5.5 months achieved by the 49 participants who instead were randomly assigned to receive niraparib alone, a significant difference with an adjusted hazard ratio for progression or death of 0.35. 

Moreover, the PFS benefit was present in the prespecified patient subgroups with homologous recombination deficiency (HRD)-positive (median 11.9 vs 6.1 months, HR=0.38) and HRD-negative disease (median 11.3 vs 4.2 months, HR=0.40), as well as those with a chemotherapy-free interval of 6–12 months (median 11.3 vs 2.2 months, HR=0.29) and more than 12 months (median 13.1 vs 6.1 months, HR=0.42). 

Patients who received the combination regimen had a higher rate of grade 3 and more severe adverse events than those given niraparib monotherapy, at 65% versus 45%, and this was “largely driven” by hypertension which occurred in 21% and 0% of patients, respectively, say the investigators. The next most common grade 3 and more severe events were anaemia (15 vs 18%) and thrombocytopenia (10 vs 12%). 

The niraparib plus bevacizumab regimen was also associated with a higher rate of any-grade proteinuria than niraparib monotherapy (21 vs 0%) and hypertension (56 vs 22%), report Mansoor Mirza, from the Rigshospitalet Copenhagen University Hospital in Denmark, and colleagues. 

The researchers emphasize the “relatively low proportion of patients discontinuing treatment”, with just 19% of the combination treatment arm discontinuing bevacizumab and 13% both treatments because of toxicity. 

“The chemotherapy-free regimen avoided the substantial cumulative toxicities associated with chemotherapy, and analyses of patient-reported outcomes revealed no relevant effect of treatment on global health status/quality of life”, they add.

The team therefore concludes: “Chemotherapy-free regimens are attractive to patients, avoiding the substantial toxicity of platinum-based regimens, and might enable prolongation of the chemotherapy-free interval.

“The combination regimen identified in AVANOVA2 will be compared with chemotherapy and bevacizumab in a randomised, phase 3 trial.” 

 

Reference 

Mirza MR, Lundqvist EÅ, Birrer MJ, et al. Niraparib plus bevacizumab versus niraparib alone for platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24): a randomised, phase 2, superiority trial. Lancet Oncol; Advance online publication 29 August 2019. https://doi.org/10.1016/S1470-2045(19)30515-7

Last update: 06 Sep 2019

medwireNews (www.medwireNews.com  ) is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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