A Phase 1b Study of OMP-305B83 Plus Weekly Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Trial ID # NCT03030287
Phase Ib
Drug Class Angiogenesis Inhibitors: VEGF/DLL4
Drug Name Navicixizumab
Alternate Drug Names OMP-305B83, anti-DLL4/VEGF bispecific monoclonal antibody OMP-305B83
Drugs in Trial Navicixizumab, Paclitaxel
Eligible Participant

Platinum-resistant or refractory ovarian cancer with >2 prior therapies

Patients Enrolled

34; median 4 prior therapies (2-12)

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, PFS, RP2D, evaluated per RECIST

Efficacy

RP2D: Pac 80mg/m2 on days 1,8,15 + Nav 3 mg/kg on days 1,15 of every 28 day cycle
ORR: 42% (11PR, n=26)
DCR: 85% (11PR, 11SD, n=26)
PFS: 5.4 months (3.5-8.0)

Exploratory analysis prior bevacizumab status:
w/ prior bevacizumab: ORR: 33% (6PR, n=18); DCR: 78% (6PR, 8SD, n=18); PFS: 3.7 months (3.3-NR)
w/o prior bevacizumab: ORR: 57% (4PR, n=7); DCR: 100% (4PR, 3SD, n=7)

Clinically Significant Adverse Events

Serious AE: 1 Gr 4 GI perforation, 1 Gr 4 thrombocytopenia
Grade 3-4 AE: hypertension (38%)

Conclusion

Promising activity of navicixizumab+paclitaxel in heavily pretreated patients

Reference

Fu S et al. A Phase Ib study of navicixizumab & weekly paclitaxel in heavily pre-treated platinum resistant ovarian, primary peritoneal or fallopian tube cancer. Ann Oncol (2018) 29 (suppl_8, abstr 951P)
https://academic.oup.com/annonc/article/29/suppl_8/mdy285.159/5141882?searchresult=1

FDA Fast Track Designation for Navicixizumab, Press release, 10/07/2019
https://www.mereobiopharma.com/news-and-events/press-releases/2019/fda-fast-track-designation-for-navicixizumab/fda-fast-track-designation-for-navicixizumab/