Table 2.
Clinical outcomes and toxicities.
| Characteristics | Total cohort N = 28 |
Evaluable cohort* N = 22 |
|---|---|---|
| N. of cycles, median (range) Years from diagnosis to therapy, median (range) Steroid and lubricant eye drop premedication, n (%) Systemic steroid/antihistamine premedication, n (%) |
3 (1-23) 7 (1-19) 28 (100) 28 (100) |
4 (2-23) 7 (1-19) 22 (100) 22 (100) |
| Response rates | ||
| ORR, n (%) CR, n (%) VGPR, n (%) PR, n (%) SD, n (%) |
11 (40) 3 (11) 3 (11) 5 (18) 3 (11) |
11 (50) 3 (14) 3 (14) 5 (22) 3 (14) |
| Median PFS, months (range) 1-year PFS Median OS, months (range) 1-year OS Median DOR, months (range) 1-year DOR |
3 (0-23) 32% 8 (0-23) 34% - - |
5 (0-23) 41% 11 (1-23) 43% N.r. (2-23) 74% |
| Keratopathy, n (%) Grades I–II Grades III–IV Drug-related discontinuation, n (%) Drug-related dose reduction, n (%) Drug-related administration delay, n (%) |
9 (32) 6 (21) 3 (11) 3 (11) 1 (3) 3 (11) |
|
| Ocular reported symptoms | ||
| Blurred vision, n (%) Dry eyes, n (%) Severe BCVA reduction, n (%) |
3 (11) 2 (7) 3 (11) |
|
| Thrombocytopenia, n (%) Grades I–II Grades III–IV |
13 (46) 9 (32) 4 (14) |
|
ORR, overall response rate; CR, complete remission; VGPR, very good partial remission; PR, partial remission; SD, stable disease; PFS, progression-free survival; OS, overall survival; DOR, response duration; BCVA, best corrected visual acuity. *Evaluable cohort = patients treated with ≥2 belantamab-mafodotin cycles.