Multicenter Phase III Randomized Study With Second Line Chemotherapy Plus or Minus Bevacizumab in Patients With Platinum Sensitive Epithelial Ovarian Cancer Recurrence After a Bevacizumab/Chemotherapy First Line

Trial ID # NCT01802749; MITO16B-MaNGO OV2B
Phase III
Drug Class Angiogenesis Inhibitors: VEGF
Drug Name Bevacizumab
Alternate Drug Names immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin
Drugs in Trial Bevacizumab, Carboplatin, Gemcitabine, Liposomal doxorubicin, Paclitaxel
Eligible Participant

Pt-sensitive ovarian cancer after first-line treatment incl. bevacizumab (recurrence or progression might occur either during or after bevacizumab as maintenance)

Patients Enrolled

406

Therapy Setting

Recurrence

Study Design

Open-Label, Randomized

Endpoints

ORR, PFS, OS, evaluated per RECIST

Efficacy

CarboPt+Pac+Bev vs CarboPt+Pac:

ORR: 74.6 (20CR, 77PR) vs 65.7% (9CR, 85PR)
PFS: 11.8 vs 8.8 months, HR: 0.51 (0.41-0.65, p<0.001)
OS: 26.6 vs 27.1 months, HR: 0.97 (0.70-1.35, p=0.98, not mature)

Clinically Significant Adverse Events

CarboPt+Pac+Bev vs CarboPt+Pac:
Serious AE:
Grade 3-4 AE: hypertension (27.5 vs 9.7%), proteinuria (4 vs 0%)

Conclusion

Rechallenge with bevacizumab in combination with platinum-based doublets is associated with a significantly prolonged PFS

Reference

Pignata S et al. Chemotherapy plus or minus bevacizumab forplatinum-sensitive ovarian cancer patients recurring after a bevacizumabcontaining first line treatment: The randomized phase 3 trialMITO16B-MaNGO OV2B-ENGOT OV17. J Clin Oncol (2018) 36 (suppl; abstr 5506)
https://meetinglibrary.asco.org/record/161812/abstract