Introduction
Methods
Data collection and patients
Study design
Cohort balancing
Sensitivity analysis
Endpoints
Treatment-effect comparisons
Results
Study sites
Patient disposition
MAS for pola-BR | MAS for R2 | MAS for CAR-T | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Tafasitamab + lenalidomide (n = 24) | Pola-BR (n = 24) | Absolute standardized difference | Tafasitamab + lenalidomide (n = 33) | R2 (n = 33) | Absolute standardized difference | Tafasitamab + lenalidomide
(n = 37) | CAR-T (n = 37) | Absolute standardized difference | ||
Matching covariates for main analysis | ||||||||||
Age, n (%) | Age <70 years | 6 (25.0) | 6 (25.0) | 0.00 | 16 (48.5) | 17 (51.5) | 0.06 | 23 (62.2) | 25 (67.6) | 0.11 |
Age ≥70 years | 18 (75.0) | 18 (75.0) | 17 (51.5) | 16 (48.5) | 14 (37.8) | 12 (32.4) | ||||
Refractoriness to last therapy line, n (%) | Yes | 17 (70.8) | 17 (70.8) | 0.00 | 19 (57.6) | 21 (63.6) | 0.12 | 23 (62.2) | 23 (62.2) | 0.00 |
No | 7 (29.2) | 7 (29.2) | 14 (42.4) | 12 (36.4) | 14 (37.8) | 14 (37.8) | ||||
Number of prior lines of therapy, n (%) | 1 | 8 (33.3) | 8 (33.3) | 0.00 | 12 (36.4) | 13 (39.4) | 0.06 | 7 (18.9) | 7 (18.9) | 0.00 |
2/3 | 16 (66.7) | 16 (66.7) | 21 (63.6) | 20 (60.6) | 30 (81.1) | 30 (81.1) | ||||
History of primary refractoriness, n (%) | Yes | 8 (33.3) | 8 (33.3) | 0.00 | 14 (42.4) | 17 (51.5) | 0.18 | 10 (27.0) | 13 (35.1) | 0.18 |
No | 16 (66.7) | 16 (66.7) | 19 (57.6) | 16 (48.5) | 27 (73.0) | 24 (64.9) | ||||
Prior ASCT, n (%) | Yes | 0 (0.0) | 0 (0.0) | NEa | 9 (27.3) | 7 (21.2) | 0.14 | 8 (21.6) | 11 (29.7) | 0.19 |
No | 24 (100) | 24 (100) | 24 (72.7) | 26 (78.8) | 29 (78.4) | 26 (70.3) | ||||
ECOG PS | 0–1 | 22 (91.7) | 22 (91.7) | 0.00 | 27 (81.8) | 27 (81.8) | 0.00 | 34 (91.9) | 34 (91.9) | 0.00 |
≥2 | 2 (8.3) | 2 (8.3) | 6 (18.2) | 6 (18.2) | 3 (8.1) | 3 (8.1) | ||||
Other characteristics | ||||||||||
Sex, n (%) | Female | 10 (41.7) | 10 (41.7) | 17 (51.5) | 11 (33.3) | 18 (48.6) | 17 (45.9) | |||
Male | 14 (58.3) | 14 (58.3) | 16 (48.5) | 22 (66.7) | 19 (51.4) | 20 (54.1) | ||||
Age at index date, years | Mean (SD) | 72.3 (8.19) | 73.7 (13.66) | 67.9 (10.54) | 69.9 (11.80) | 65.8 (10.79) | 63.7 (11.45) | |||
Median (Q1–Q3) | 73.0 (69.5–78.5) | 78.5(69.5–81.0) | 72.0 (58.0–75.0) | 69.0 (63.0–78.0) | 68.0 (58.0–75.0) | 64.0 (57.0–70.0) | ||||
Range (min–max) | 55–86 | 30–91 | 47–82 | 31–91 | 41–82 | 30–92 | ||||
Neutropenia (cut-off <1.5 x 109/L), n (%) | Yes | 0 (0.0) | 3 (12.5) | 0 (0.0) | 4 (12.1) | 0 (0.0) | 1 (2.7) | |||
No | 24 (100) | 17 (70.8) | 33 (100) | 28 (84.8) | 37 (100) | 36 (97.3) | ||||
Missing | 0 (0.0) | 4 (16.7) | 0 (0.0) | 1 (3.0) | 0 (0.0) | 0 (0.0) | ||||
Anemia (cut-off hemoglobin <10 g/dL), n (%) | Yes | 1 (4.2) | 6 (25.0) | 2 (6.1) | 6 (18.2) | 5 (13.5) | 8 (21.6) | |||
No | 23 (95.8) | 17 (70.8) | 31 (93.9) | 26 (78.8) | 32 (86.5) | 29 (78.4) | ||||
Missing | 0 (0.0) | 1 (4.2) | 0 (0.0) | 1 (3.0) | 0 (0.0) | 0 (0.0) | ||||
Elevated LDH (>ULN), n (%) | Yes | 14 (58.3) | 18 (75.0) | 20 (60.6) | 22 (66.7) | 19 (51.4) | 21 (56.8) | |||
No | 10 (41.7) | 4 (16.7) | 13 (39.4) | 8 (24.2) | 18 (48.6) | 15 (40.5) | ||||
Missing | 0 (0.0) | 2 (8.3) | 0 (0.0) | 3 (9.1) | 0 (0.0) | 1 (2.7) | ||||
Race, n (%) | Black or African American | 0 (0.0) | 1 (4.2) | 0 (0.0) | 2 (6.1) | 0 (0.0) | 6 (16.2) | |||
American Indian | 0 (0.0) | 1 (4.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||||
Asian | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (6.1) | 0 (0.0) | 2 (5.4) | ||||
Native Hawaiian or other Pacific Islander | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||||
White | 23 (95.8) | 19 (79.2) | 28 (84.8) | 17 (51.5) | 34 (91.9) | 19 (51.4) | ||||
Unknown | 0 (0.0) | 2 (8.3) | 0 (0.0) | 3 (9.1) | 0 (0.0) | 3 (8.1) | ||||
Other | 0 (0.0) | 1 (4.2) | 1 (3.0) | 9 (27.3) | 0 (0.0) | 7 (18.9) | ||||
Missing | 1 (4.2) | 0 (0.0) | 4 (12.1) | 0 (0.0) | 3 (8.1) | 0 (0.0) | ||||
Primary progressive disease, n (%) | Yes | 1 (4.2) | 3 (12.5) | 2 (6.1) | 8 (24.2) | 2 (5.4) | 6 (16.2) | |||
No | 23 (95.8) | 21 (87.5) | 31 (93.9) | 25 (75.8) | 35 (94.6) | 31 (83.8) | ||||
Early relapse, n (%) | Yes | 7 (29.2) | 5 (20.8) | 12 (36.4) | 9 (27.3) | 8 (21.6) | 7 (18.9) | |||
No | 17 (70.8) | 19 (79.2) | 21 (63.6) | 24 (72.7) | 29 (78.4) | 30 (81.1) | ||||
IPI score, n (%) | 0–2 | 11 (45.8) | 5 (20.8) | 15 (45.5) | 4 (12.1) | 18 (48.6) | 17 (45.9) | |||
3–5 | 13 (54.2) | 14 (58.3) | 18 (54.5) | 16 (48.5) | 19 (51.4) | 13 (35.1) | ||||
Missing | 0 | 5 (20.8) | 0 | 13 (39.4) | 0 | 7 (18.9) | ||||
Ann Arbor disease stage, n (%) | I+II | 3 (12.5) | 4 (16.7) | 8 (24.2) | 2 (6.1) | 6 (16.2) | 8 (21.6) | |||
III+IV | 21 (87.5) | 14 (58.3) | 25 (75.8) | 17 (51.5) | 31 (83.8) | 18 (48.6) | ||||
Missing | 0 | 6 (25.0) | 0 | 14 (42.4) | 0 | 11 (29.7) |