Table 2. Oncology clinical trails assessing Bavituximab.
| Indication | Phase | Trial design | n | Experimental regimen | Results |
|---|---|---|---|---|---|
| Company sponsored | |||||
| Refractory advanced solid tumorsa | I | Single-arm, dose escalation | 26 | Bavituximab monotherapy (0.1, 0.3, 1.0, 3.0 mg/kg) | Well tolerated, pharmacokinetics support weekly dosing |
| Refractory advanced solid tumorsb | I | Single-arm | 14 | Bavituximab+chemotherapy for indication | Well tolerated in combination |
| Second-line advanced breast cancerc | II | Single-arm | 46 | Bavituximab (3mg/kg)+docetaxel | Overall response rate: 61% Median progression-free survival: 7.4 months (mo.) Median overall survival: 20.7 mo |
| Front-line non-small cell lung cancerd | II | Single-arm | 49 | Bavituximab (3mg/kg)+carboplatin/paclitaxel | Overall response rate: 41% Median progression-free survival: 6.0 mo Median overall survival: 12.4 mo. |
| Advanced pancreatic cancere | IIb | Randomized, open label | 70 | Bavituximab (3mg/kg)+gemcitabine versus gemcitabine | Overall response rate: 28.1% versus 12.9% Median overall survival: 5.6 versus: 5.2 mo |
| Second-line non-small cell lung cancerf | IIb | Randomized, double blind* | 121 | Bavituximab (3mg/kg or 1mg/kg) or Placebo + docetaxel* | Overall response rate: 17.1% versus 11.3%* Median Progression-free survival: 4.2 versus 3.9 mo* Median overall survival: 11.7 versus 7.3 mo* |
| Investigator sponsored | |||||
| Front-line HER2-negative breast cancerg | I | Single-arm | 14 | Bavituximab (3mg/kg)+paclitaxel | Overall response rate: 85% Complete response: 15% |
| Front-line stage IV non-small cell lung cancerh | I | Single-arm | 25 | Bavituximab (3mg/kg)+carboplatin/pemetrexed | Overall response rate: 35% Median progression-free survival: 4.8 mo Median overall survival: 12.2 mo |
| Front-line hepatocellular carcinomai | I/II | Single-arm, dose escalation | 48 | Bavituximab (0.1, 0.3, 1.0, 3.0 mg/kg)+sorafenib | Median time to progression 6.7 mo Median overall survival: 6.2 mo |
Company-sponsored and investigators-sponsored bavituximab clinical trials. References are indicated where relevant
a
Gerber et al.118
b
Digumarti et al.,130 J. Clin Oncol, 2008, 26 (Suppl) Abstract #3038
c
Tabagari et al.,131 J. Clin Oncol, 2010, 28 (Suppl) Abstract 1042
d
Digumarti et al.117
e
Pandya et al.,132 J. Clin Oncol, 2013, 31 (Suppl) Abstract 4054
f
Shtivelband et al.,133 J. Clin Oncol, 2013, 31 (Suppl) Abstract 8095
g
Chalasani et al.116
h
Grilley-Olson et al.134 Chicago Multidisciplinary Symposium on Thoracic Oncology, 2014 Abstract #215
i
Yopp et al.,135 J. Clin Oncol, 2015, 33 (Suppl) Abstract 4109
*
Placebo and 1 mg/kg bavituximab arms were combined for analysis and compared to 3 mg/kg bavituximab arm