Table 2.
Adverse events in ≥20% of patients in phase 1b trials.
Study | Chow et al. 2017 [12] | Shayan et al. 2018 [13] | Machiels et al. 2013 [14] * |
---|---|---|---|
Agent | Motolimod | Motolimod | IMO-2055 |
Treatment | Motolimod + cetuximab | Motolimod + cetuximab | IMO-2055 + 5-fluorouracil, cisplatin, and cetuximab |
Number of Patients | 13 | 14 | 13 |
Dosage | Motolimod: 2.5 mg/m2, 3.0 mg/m2, or 3.5 mg/m2 Cetuximab: 250 mg/m2 |
Motolimod: 2.5 mg/m2 Cetuximab: 400 mg/m2 loading then 250 mg/m2 |
IMO-2055: 0.16 mg/kg or 0.32 mg/kg Cetuximab: 400 mg/m2 loading then 250 mg/m2 Cisplatin: 100 mg/m2/day 5-fluorouracil: 1000 mg/m2/day |
Flu-Like Symptoms (%) | 92 | 36 | - |
Injection Site Reaction (%) | 92 | 79 | 54 |
Fatigue (%) | 85 | 21 | 39 |
Rash (%) | 38 | 79 | 39 |
Grade 3+ AEs (%) | 8 | - * | 92 |
Fatal AEs (%) | 0 | 0 | 8 |
Discontinued Due to AEs (%) | 0 | 0 | 31 |
* No grade 4 or 5 AEs reported.