Table 3.
Listing of all APVO436-related serious adverse events (SAEs).
| Patient No. | Cohort# | SAE Reported Term (CTCAE Grade) | Start Date (CxDx); # of Days from ICF | End Date (# of Days from ICF | Total Duration of the SAE (Days) |
SAE Outcome |
Changes to Drug Dose or Schedule | SUSAR (Yes/No) |
|---|---|---|---|---|---|---|---|---|
| UPN02 | 1 | CRS (3) | C6D1; 148 | 155 | 8 | Resolved | DPD | Yes |
| Rigors (3) | C6D1; 148 | 150 | 3 | Resolved | DPD | No | ||
| Chills (3) | C6D1; 148 | 150 | 3 | Resolved | DPD | No | ||
| Dyspnea (3) | C6D1; 148 | 150 | 3 | Resolved | DPD | No | ||
| Hypotension (3) | C6D1; 148 | 150 | 3 | Resolved | DPD | No | ||
| UPN04 | 1 | IRR (1)—fever (3) | C1D8; 14 | 16 | 3 | Resolved | None | Yes |
| UPN12 | 4 | Acute renal failure (5) (complication of CRS [2]) | C2D1; 55 | 55 | 1 | Fatal | DPD | Yes |
| CRS (2) | C2D1; 43 | NA | >12 | NR | DD | No | ||
| UPN14 | 4 | CRS (1) | C1D3; 10 | 13 | 4 | Resolved | DD | Yes |
| UPN16 | 4 | CRS (4) | C1D5; 19 | 24 | 6 | Partially Resolved | DPD | Yes |
| Respiratory failure—acute (4) | C1D5; 19 | 21 | 3 | Resolved | DPD | Yes | ||
| UPN17 | 5 | IRR (1) | C3D1; 65 | 67 | 3 | Resolved | None | No |
| UPN20 | 6A | Sepsis (3) | C6D15; 165 | 169 | 5 | Resolved | TI | Yes |
| UPN22 | 6A | CRS (3) | C1D3; 6 | 15 | 10 | Resolved | DR/DD | No |
| Pulmonary edema | C1D3;6 | 15 | 10 | resolved | DD | No | ||
| Hypoxia intermittent (3) | C1D3; 6 | 10 | 5 | Resolved | DD | No | ||
| Worsening dyspnea (2) | C1D3; 6 | 15 | 10 | Resolved | DD | No | ||
| Pulmonary infiltrates (3) | C1D3; 6 | 15 | 10 | Resolved | DD | No | ||
| UPN24 | 6A | Generalized weakness (3) | C1D5; 11 | 38 | 28 | Resolved | DD | Yes |
| UPN30 | 7 | IRR (2) | C2D15; 56 | 59 | 4 | Resolved | TI | No |
| UPN31 | 7 | CRS (2) | C5D1; 120 | 121 | 2 | Resolved | TI | No |
| Rigors (2) | C5D1; 120 | 120 | 1 | Resolved | None | No | ||
| UPN38 | 8 | N-STEMI 2° to CRS (3) | C1D1; 5 | 6 | 2 | Resolved | TI | No |
| Fluid overload (3) | C1D11; 21 | 23 | 3 | Resolved | None | No | ||
| Fever (2) | C1D1; 5 | 5 | 1 | Resolved | TI | No | ||
| Hypotension (3) | C1D1; 5 | 5 | 1 | Resolved | TI | No | ||
| Rigor (2) | C1D1; 5 | 5 | 1 | Resolved | TI | No | ||
| CRS (3) | C1D1; 5 | 6 | 2 | Resolved | TI | No | ||
| UPN46 | NA | Neurotoxicity (1) | C1D1; 10 | 11 | 2 | Resolved | DPD | Yes |
In UPN16 CRS was complicated by grade 3 pleural effusion, grade 4 acute hypoxemic respiratory failure, and grade 3 acute kidney injury (AKI). UPN46 was also assigned to treatment with APVO436 according to an exploratory dose-intense daily regimen but was taken off the study after developing grade 1 neurotoxicity with transient confusion during the first infusion (6 mcg intended dose level; actual dose received: 1.5 mcg). TI: temporarily interrupted (including interruption of infusion or discontinuation of infusion for the day of the AE); DPD: drug permanently discontinued; DD: next dose delayed; DR: dose reduced; CRS: cytokine release syndrome.