Table 2.
Progression
| n (%) | |
|---|---|
| Progression | |
| No | 112 (76.7) |
| Yes | 34 (23.3) |
| ECOG at Recurrence | |
| 0 | 21 (61.8) |
| 1 | 8 (23.5) |
| 2 | 3 (8.8) |
| 3 | 2 (5.9) |
| LDH at Recurrence | |
| Normal | 18 (52.9) |
| 1–2x upper limit of normal | 9 (26.5) |
| >2x upper limit of normal | 3 (8.8) |
| Unknown | 4 (11.8) |
| Sites of Progression | |
| 1 | 23 (67.6) |
| 2 | 5 (14.7) |
| 3+ | 6 (17.6) |
| Location of Progression ** | |
| Adrenal | 2 (5.9) |
| Bone | 4 (11.8) |
| Brain | 18 (52.9) |
| Cutaneous/subcutaneous (location of primary) | 6 (17.6) |
| Liver | 4 (11.8) |
| Lung | 7 (20.6) |
| Lymph nodes | 10 (29.4) |
| Other GI (pancreas, peritoneum, small bowel) | 3 (8.8) |
| Treatment of Progression after BRAF/MEK Inhibitor Therapy | |
| Surgery | 10 (29.4) |
| Radiotherapy | 15 (44.1) |
| Systemic Treatment Received for Progression *** | 24 (70.6) |
| Anti-PD-1 monotherapy | 11 (45.8) |
| Response rate | 36.4% |
| Clinical benefit | 54.5% |
| Anti-PD-1/CTLA-4 | 6 (25.0) |
| Response rate | 0.0% |
| Clinical benefit | 33.3% |
| BRAF/MEK inhibitor | 9 (37.5) |
| Response rate | 55.6% |
| Clinical benefit | 77.8% |
| Best Investigator Assessed RECIST 1.1 Response to Therapy | |
| SD | 6 (25.0) |
| PR | 4 (16.7) |
| CR | 3 (12.5) |
| PD | 9 (37.5) |
| NED (no further progression) | 2 (8.3) |
| Subsequent Progression Following Treatment | 19 (55.9) |
*
Adverse events (not treatment related), other treatment became available in extended access program
**
10 patients had recurrence at more than one site
***
One patient received PD-1 monotherapy, anti-PD-1/CTLA-4, and BRAF/MEK inhibitor therapy, clinical benefit includes RECIST stable disease in addition to partial and complete response.