Table 1.
Characteristics of Symptomatic Patients
| Pt. No. | BRAF Status | Prior Cancer Treatment | PD-L1 Expression | ECOG PS | IC Baseline Target Lesions (No.) | Tumor Burden (mm) | Corticosteroid use(baseline; mg/day) | Induction Doses | Maintenance Doses | Best IC Response | Duration of IC Response (Months) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Mutant | – | 0 to 1% | 0 | 1 | 8 | D: 2 | 4 | 37 | CR | >12.5 (ongoing) |
| 2 | Wild-type | – | 1 to <5% | 1 | 2 | 5, 5 | 0 | 1 | 23 | CR | ≥9.6 (ongoing) |
| 3 | Mutant | – | 5 to <20% | 1 | 3 | 8, 5, 6 | 0 | 4 | 23 | PR | ≥4.1 (ongoing)a |
| 4 | Not reported | SRT | Not determined | 1 | 1 | 22 | D: 2b | 3 | 0 | PR | >2.7 (off-treatment) |
| 5 | Wild-type | – | Not determined | 1 | 1 | 7 | D: 2 | 1 | 0 | No SD >6 mo | – |
| 6 | Mutant | – | Not determined | 0 | 2 | 24, 25 | D: 4 | 1 | 0 | No SD >6 mo | – |
| 7 | Wild-type | Adjuvant (investigational) | Not determined | 0 | 2 | 14, 15 | D: 4 | 2 | 0 | PD | – |
| 8 | Wild-type | – | 0 to <1% | 0 | 5 | 17, 18, 27, 16, 8 | D: 4 | 2 | 0 | PD | – |
| 9 | Wild-type | SRT | 0 to <1% | 0 | 3 | 16, 6, 6 | D: 2, 1 | 1 | 1 | PD | – |
| 10 | Wild-type | Adjuvant (interferon) | Not evaluable | 1 | 3 | 12, 11, 6 | D: 4, 4 | 1 | 0 | PD | – |
| 11 | Mutant | – | 0 to <1% | 0 | 1 | 19 | D: 2 | 1 | 0 | PD | – |
| 12 | Mutant | Metastatic (dabrafenib + trametinib) | 0 to <1% | 0 | 2 | 9, 5 | 0 | 1 | 0 | PD | – |
| 13 | Mutant | – | Not determined | 1 | 2 | 16, 18 | D: 4 | 1 | 0 | PD | – |
| 14 | Wild-type | – | 1 to <5% | 1 | 2 | 19, 6 | 0 | 2 | 0 | PD | – |
| 15 | Mutant | Metastatic (dabrafenib + trametinib) | 0 to <1% | 0 | 3 | 23, 20, 9 | D: 4 | 2 | 0 | PD | – |
| 16 | Wild-type | – | Not determined | 1 | 3 | 22, 21, 13 | D: 8c, 4, 2, 4 | 1 | 0 | PD | – |
| 17 | Not reported | – | ≥20% | 1 | 3 | 5, 18, 6 | 0 | 2 | 0 | Death | – |
| 18 | Mutant | – | Not evaluable | 2 | 2 | 6, 5 | 0 | 1 | 0 | Death | – |
Abbreviations: CR, complete response; D, dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; IC, intracranial; mo. month; No., number; PD, progressive disease; PD-LI, programmed death ligand 1; PR, partial response; SD, stable disease; SRT, stereotactic radiotherapy.
aResponse date was not recorded by the investigator and was derived based on the lesion data.
bAfter the database was locked, this patient was identified as having received dexamethasone 2 mg at baseline by the investigator.
cPatient received 8 mg of dexamethasone outside of the 10-day window that restricted doses to no more than 4 mg/day.