Table 1.
Completed single agent BCR trials in NHL
| Disease/Drug | Number of patients | Patient population (median age) | OR | Median PFS | Reference |
|---|---|---|---|---|---|
| MCL | |||||
| Ibrutinib | 56 (9 MCL) | R/R NHL (65) | ALL NHL: 54% (14% CR) MCL: 78% (33% CR) |
13.6 months | Advani2 |
| Ibrutinib | 111 | R/R MCL (68) | 68% (21% CR) | 13 months | Wang3,4 |
| Idelalisib | 40 | R/R MCL (69) | 40% (5% CR) | 3.7 months | Kahl10 |
| Enzasturin | 60 | R/R MCL (66) | 0%, 10% FFP for > 6 months | 2 months | Morschhauser40 |
| Fostamatinib | 68 (9 MCL) | R/R NHL (61) | MCL: 11% (0% CR) | 3.8 months | Friedberg41 |
| DLBCL | |||||
| Ibrutinib | 56 (7 DLBCL) | R/R NHL (65) | ALL NHL: 54% OR (14% CR) DLBCL: 29% (0 CR) |
13.6 months | Advani2 |
| Ibrutinib | 70 | R/R DLBCL (63) | ALL DLBCL: 21% (5% CR) ABC DLBCL: 40% (8% CR) GCB DLBCL: 5.3% (0 CR) |
ALL DLBCL: 1.6 months ABC DLBCL: 2.5 months GCB DLBCL: 1.3 months |
Wilson14 |
| Fostamatinib | 68 (23 DLBCL) | R/R NHL (61) | DLBCL: 22% (4% CR) | 2.7 months | Friedberg41 |
| Fostamatinib | 68 | R/R DLBCL (65) | 3% (1.5% CR) | NA | Flinn42 |
| Enzasturin | 55 | R/R DLBCL (68) | NA | 15% free from progression after 4 cycles | Robertson17 |
| Enzasturin (PRELUDE) | 758 | Front-line DLBCL (64) | NA: all in CR at enrollment | DFS at 48 months 71% enzasturin vs. 70% placebo (HR 0.92, p=0.54) | Crump18 |
| BKM120 | 64 (26 DLBCL) | R/R NHL (63.5) | DLBCL: 12% (4% CR) | NA | Younes20 |
| FL | |||||
| Idelalisib | 64 (38 FL) | R/R Indolent NHL (64) | ALL NHL: 47% (1.6% CR) FL: 45% OR |
7.6 months | Flinn21 |
| Idelalisib | 125 (72 FL) | R/R Indolent NHL (64) | ALL NHL: 57% (6% CR) FL: 54% |
11 months | Gopal22,23 |
| Ibrutinib | 56 (16 FL) | R/R NHL (65) | ALL NHL: 54% (14% CR) FL: 38% (19% CR) |
13.4 months | Advani2 and Fowler26 |
| Ibrutinib | 40 | R/R FL (64) | 30% (3% CR) | 9.9 months | Bartlett27 |
| Fostamatinib | 68 (21 FL) | R/R NHL (61) | FL: 10% (0 CR) | 4.6 months | Friedberg41 |
| Enzasturin | 66 | R/R FL (62) | 26% (4% CR) | 18.1 months | Schwartzberg43 |
| WM | |||||
| Ibrutinib | 56 (4 WM) | R/R NHL (65) | ALL NHL: 54% (14% CR) WM: 75% (0 CR) |
13.6 months | Advani2 |
| Ibrutinib | 63 | R/R WM (63) | 90% (73% Major response) | 2-year PFS 69.1% | Treon28 |
| Idelalisib | 64 (9 WM) | R/R (64) | 47% (1.6% CR) WM: 55% |
7.6 months | Flinn21 |
| Idelalisib | 125 (10 WM) | R/R (64) | 57% (6% CR) W: 80% |
11 months | Gopal22,23 |
| Enzasturin | 42 | R/R WM (65) | 38.1% | 10.9 months | Ghobrial44 |
Abbreviations: OR: Overall response; PFS: Progression-free survival; R/R: relapsed/refractory; MCL: Mantle cell lymphoma; NHL: non-Hodgkin's lymphoma; CR: complete response; DLBCL: diffuse large B-cell lymphoma; ABC: activated B-cell; GCB: germinal center B-cell; NA: not available DFS: disease free survival; FL: follicular lymphoma; WM: Waldenstrom's macroglobulinemia; PFS: progression-free survival.