Clinical response in patients receiving tagraxofusp 12 μg/kg per day
| Response∗ . | Treatment naïve (n = 15) . | Relapsed/refractory (n = 22) . |
|---|---|---|
| Follow-up, median (range), mo | NE (0.99-47.18) | 43.7 (0.36-45.01) |
| Patients bridged to allo-SCT, n (%) | 0 | 2 (9)† |
| ORR, n (%) | 0 | 0 |
| Best response, n (%) | ||
| CR | 0 | 0 |
| CCyR + optimal MR | 1 (7) | 1 (5) |
| PR | 0 | 0 |
| SD‡ | 6 (40) | 13 (59) |
| SD (>8 weeks) | 6 (40) | 7 (32) |
| Clinical benefit (any) | 4 (27) | 5 (23) |
| Erythroid response | 1 (7) | 0 |
| Erythroid + platelet response | 0 | 1 (5) |
| Erythroid + neutrophil response | 0 | 1 (5) |
| Platelet + spleen response | 0 | 1 (5) |
| Platelet response | 1 (7) | 1 (5) |
| Neutrophil response | 1 (7) | 0 |
| Spleen response | 0 | 1 (5) |
| Symptom response | 1 (7) | 0 |
| PD | 4 (27) | 3 (14) |
| Response∗ . | Treatment naïve (n = 15) . | Relapsed/refractory (n = 22) . |
|---|---|---|
| Follow-up, median (range), mo | NE (0.99-47.18) | 43.7 (0.36-45.01) |
| Patients bridged to allo-SCT, n (%) | 0 | 2 (9)† |
| ORR, n (%) | 0 | 0 |
| Best response, n (%) | ||
| CR | 0 | 0 |
| CCyR + optimal MR | 1 (7) | 1 (5) |
| PR | 0 | 0 |
| SD‡ | 6 (40) | 13 (59) |
| SD (>8 weeks) | 6 (40) | 7 (32) |
| Clinical benefit (any) | 4 (27) | 5 (23) |
| Erythroid response | 1 (7) | 0 |
| Erythroid + platelet response | 0 | 1 (5) |
| Erythroid + neutrophil response | 0 | 1 (5) |
| Platelet + spleen response | 0 | 1 (5) |
| Platelet response | 1 (7) | 1 (5) |
| Neutrophil response | 1 (7) | 0 |
| Spleen response | 0 | 1 (5) |
| Symptom response | 1 (7) | 0 |
| PD | 4 (27) | 3 (14) |
Data presented are for the intent-to-treat population.
MR, marrow response; NE, not estimable; ORR, overall response rate; PD, progressive disease; PR, partial response.
Modified 2015 MDS/MPN response criteria with an added category of SD (see supplemental Appendix).
Patients who were bridged to allo-SCT included 2 patients in the relapsed/refractory cohort who achieved SD.
SD is defined as those patients not belonging to any of the defined categories in the 2015 criteria (including PD).