Article Figures & Data
Figures
- Figure 1.
Mechanism of action of VB-111. VB-111 targeted to angiogenic endothelial cells.
- Figure 2.
A, pharmacokinetics: copies of Ad-5 DNA detected in whole blood (mean) by treatment cohort. Dose response shows at least 2-log reduction in Ad-5 levels by RT-PCR at day 56. B, levels of anti-Ad-5 IgG postdosing, cohorts 6–7. Levels reach a plateau at 14 to 28 days, without apparent dose response.
- Figure 3.
Tumor response, overall survival, and progression-free survival. A, cohorts 1–5 tumor response at day 56. B, cohorts 6 and 7 tumor response at day 56. C, overall survival: 187 versus 173 days versus not reached in cohort 1–5 versus 6 versus 7, respectively (P = 0.012). (Continued on the following page). D, time to progressive disease: 31 versus 55 versus 121 days in cohort 1–5 versus 6 versus 7, respectively (P = 0.24). E, overall survival in cohort 1–6 versus 7: 173 days versus not reached (P = 0.0098). F, time to progressive disease in cohort 1–6 versus 7: 34.5 vs. 121 days (P = 0.10).
- Figure 4.
Partial response (RECIST criteria) in a patient with metastatic papillary thyroid cancer, radioiodine resistant. At 6 months, there is a 30% reduction in the lesion diameter, central necrosis, and no pressure on trachea.
Tables
- Table 1.
Demographics and baseline characteristics
N = 33 Age, median (range), y 59 (35—77) Gender Male 17 (52%) Female 16 (48%) Karnofsky, median (range) 90 (70–100) Tumor type Colorectal/adenocarcinoma 11 Carcinoid/neuroendocrine 4 NSCLC 3 RCC 3 Melanoma 2 Sarcoma 2 Thyroid 2 Merkel cell 1 Small cell lung 1 Bladder/transitional cell 1 Gastrointestinal stromal tumor 1 Testicular/sex cord 1 Esophageal adenocarcinoma 1 Treatment history Surgery 24 (73%) Radiotherapy 15 (45%) Chemotherapy 29 (88%) 1 prior regimen 2 (6%) 2 prior regimens 9 (6%) ≥3 prior regimens 18 (55%) Abbreviations: NSCLC, non–small cell lung cancer; RCC, renal cell carcinoma.
- Table 2.
Summary of adverse events
Cohorts 1–4 (n = 12) Cohort 5 (n = 3) Cohort 6 (n = 12) Cohort 7 (n = 6) Total (N = 33) Adverse event Grade 1–2 Grade 3 Grade 1–2 Grade 3 Grade 1–2 Grade 3 Grade 1–2 Grade 3 Grade 1–2 Grade 3 Frequent drug-related adverse events Nausea 0 0 0 0 2 0 2 0 4 0 Chills 0 0 1 0 6 0 2 0 9 0 Fever 1 0 2 0 9 0 5 1 18 1 aPTT prolonged 0 0 0 0 3 0 0 0 3 0 ALT increased 0 0 0 0 0 0 3 0 3 0 AST increased 0 0 0 0 1 0 3 0 4 0 Anorexia 0 0 1 0 2 0 0 0 3 0 Dizziness 0 0 1 0 0 0 2 0 3 0 Hyperhidrosis 0 0 0 0 3 0 0 0 3 0 Cohorts 1–4 (n = 12) Cohort 5 (n = 3) Cohort 6 (n = 12) Cohort 7 (n = 6) Total (n = 33) All Related All Related All Related All Related All Related All grade 3–4 adverse events Abdominal pain/cramping 0 0 0 0 1 0 1 0 2 0 Asthenia 0 0 0 0 1 0 0 0 1 0 Disease progression 1 0 0 0 0 0 0 0 1 0 Fatigue 2 0 0 0 0 0 0 0 2 0 Pyrexia 0 0 0 0 0 0 1 1 1 1 LFT increase 0 0 0 0 1 0 0 0 1 0 Hyperbilirubinemia 0 0 0 0 1 0 0 0 1 0 Anemia 1 0 0 0 0 0 0 0 1 0 Hemoglobin decreased 1 0 0 0 0 0 0 0 1 0 Hyperglycemia 0 0 0 0 1 0 0 0 0 0 Electrolyte disorders 5 0 0 0 1 0 0 0 6 0 Spinal cord compression 0 0 0 0 0 0 1 0 1 0 Suicidal ideation 0 0 0 0 1 0 0 0 1 0 NOTE: All events occurring in 3 or more patients and all grade 3–4 events.
Abbreviation: LFT, liver function test.
- Table 3.
Patient disease response
Individual patient data Cohort summary Day 28 Day 56 PFS OS Cohort Patient Cancer type Day 28 Day 56 SD PD PR SD PD PR (median), mo (median), mo 1 01–001 Gastrointestinal stromal tumor PD PD 1/3 (33%) 2/3 (67%) 0/3 (0%) 0/3 (0%) 2/3 (67%) 0/3 (0%) 1.0 3.9 01–002 Sarcoma SD LTFU 01–003 Testicular/sex cord carcinoma PD PD 2 01–004 TCC bladder PD PD 1/3 (33%) 2/3 (67%) 0/3 (0%) 0/3 (0%) 3/3 (100%) 0/3 (0%) 0.9 10.5 01–005 Sarcoma SD PD 01–006 CRC PD PD 3 01–007 CRC SD SD 1/3 (33%) 2/3 (67%) 0/3 (0%) 1/3 (33%) 2/3 (66%) 0/3 (0%) 1.9 8.5 01–008 Melanoma PD PD 01–009 NSCLC PD PD 4 01–010 CRC SD SD 1/3 (33%) 1/3 (33%) 0/3 (0%) 1/3 (33%) 1/3 (33%) 0/3 (0%) 0.9 3.7 02–013 CRC PD PD 01–014 NSCLC LTFU LTFU 5 02–020 CRC PD PD 1/3 (33%) 2/3 (67%) 0/3 (0%) 1/3 (33%) 2/3 (67%) 0/3 (0%) 0.9 2.7 02–021 SCLC SD SD 01–024 CRC PD PD 6 02–022 Carcinoid SD SD 8/12 (67%) 4/12 (33%) 0/12 (0%) 5/12 (42%) 6/12 (50%) 0/12 (0%) 1.8 5.8 02–025 Melanoma SD N/A 02–026 Papillary thyroid carcinoma SD SD 02–027 CRC PD PD 02–028 CRC SD SD 01–029 NET SD SD 02–030 CRC SD SD 02–032 RCC SD PD 01–033 CRC PD PD 02–035 Merkel cell carcinoma SD PD 01–036 Esophageal carcinoma PD PD 01–038 CRC PD PD 7 01–039 NET PD PD 4/6 (67%) 2/6 (33%) 0/6 (0%) 4/6 (67%) 2/6 (33%) 0/6 (0%) 4.0 16.2 02–040 Medullary thyroid carcinoma SD SD 01–041 NET SD SD 01–042 NSCLC SD SD 02–043 RCC SD SD 02–044 RCC PD PD Abbreviations: CRC, colorectal carcinoma; LTFU, lost to follow-up; NET, neuroendocrine tumor; NSCLC, non–small cell carcinoma; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; RCC, renal cell carcinoma; SCLC, small cell lung carcinoma; SD, stable disease; TCC, transitional cell carcinoma.
Volume 19, Issue 14
