Table 3:
Bevacizumab Approvals in Ovarian Cancer: 2010-2020*
| Trial supporting approval |
Population Studied |
Study Design | Primary Endpoint | Select Secondary Endpoints | Approved Indication |
|---|---|---|---|---|---|
| GOG-021818 | First-Line OC treatment and maintenance | DB, PC, R (1:1:1) CPB+B (n=623) versus CPB (n=625) versus CP (n=625) |
PFS: median 18.2 versus 12 months (HR 0.62; 95% CI: 0.52–0.75) for CPB+B versus CP | OS: median 43.8 versus 40.6 months (HR 0.89; 95% CI: 0.76–1.05) for CPB+B versus CP | Patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. RA granted on June 13, 2018 |
| PAOLA-118,41,55,57 | First-Line maintenance | DB, PC, R (2:1) O+B (n=537) versus P+B (n=269) |
PFS (HRD-positive population): median 37.2 versus 17.7 months (HR 0.33; 95% CI: 0.25-0.45) | OS: Immature | In combination with olaparib for patients with newly diagnosed advanced ovarian cancer associated with homologous recombination deficiency positive (HRD+) status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. RA granted on May 8, 2020 |
| OCEANS18,39 | Recurrent OC, platinum sensitive | R (1:1) CG+B (n=242) versus CG+P (n=242) | PFS: median 12.4 versus 8.4 months (HR 0.46; 95% CI: 0.37, 0.58) | OS: Not significantly improved (HR 0.95; 95% CI: 0.77 - 1.17) ORR: 78% versus 57% |
In combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by bevacizumab alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. RA granted on December 6, 2016 |
| GOG-021318,40 | R (1:1) CPB (n=337) versus CP (n=336) | OS: median 42.6 versus 37.3 months (HR 0.82; 95% CI: 0.68, 0.996) | PFS: median 13.8 versus 10.4 months (HR 0.61; 95% CI: 0.51, 0.72) for CPB versus CP ORR: 78% versus 56% |
||
| AURELIA18,38 | Recurrent OC, platinum resistant | R (1:1) Chemo + Bevacizumab (n=179) versus Chemo (n=182) | PFS: median 6.8 versus 3.4 months (HR 0.38; 95% CI: 0.30–0.49) | OS: median 16.6 versus 13.3 months (HR 0.89; 95% CI: 0.69–1.14) ORR: 28% versus 13% DoR: 9.4 versus 5.4 months |
In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for the treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. RA granted on November 14, 2017 |
*
Data in the table reflects updated information from the recent product USPI, as dated in the references
R: Randomized; DB: Double-blind; PC: Placebo controlled; CP: carboplatin plus paclitaxel; CPB: carboplatin plus paclitaxel with bevacizumab; CPB+B: carboplatin plus paclitaxel with bevacizumab for six cycles followed by single-agent bevacizumab maintenance treatment; O+B: olaparib
+
bevacizumab maintenance; P+B: placebo + bevacizumab maintenance; CG+B: carboplatin plus gemcitabine with bevacizumab; CG+P: carboplatin plus gemcitabine with placebo; Chemo: weekly paclitaxel, topotecan, or pegylated liposomal doxorubicin