Treatment | Target specificity | Publication/NCT# | Phase | Total n [FL] | Median lines of prior therapy | ORR%a [CR%] | Median PFS (mos) | Grade ≥ 3 AEs (%)b | Approved |
---|---|---|---|---|---|---|---|---|---|
Single agent studies | |||||||||
Idelalisib | δ | [36] | II | 125 [72] | 4 | 45 [3] | 11 | Neutropenia [27], LFT elevation [13], diarrhea [13], PNA [7] |  +  |
Copanlisib | α/δ | II | 142 [104] | 3 | 59 [20] | 12.5 |  +  | ||
Duvelisib | δ/γ | [41] | II | 129 [83] | 3 | 42 [1] | 9.5 | Neutropenia [25], anemia [15], diarrhea [15], thrombocytopenia [12], LFT rise [5], lipase rise [7], colitis [5], PNA [5], |  +  |
Umbralisib | δ, CK1ε | [44] | II | 208 [117] | 2 | 45 [5] | 10.6 |  +  | |
Parsaclisib | δ | NCT03126019 | II | NAc | NAc | NAc | NAc | NAc | – |
Zandelisib | δ | NCT03768505 | II | NAc | NAc | NAc | NAc | NAc | – |
YY-20394 | δ | NCT04370405 | II | NAc | NAc | NAc | NAc | NAc | – |
Tenalisib | δ/γ | NCT03711578 | II | NAc | NAc | NAc | NAc | NAc | – |
Combination studies | |||||||||
Duvelisib + BR or R | δ/γ | [50] | I | 46 [15] | 2 | Duvelisib + R: 62 [19], Duvelisib + BR: 58 [17]d | Duvelisib + R: 10.7, Duvelisib + BR: 5.3d | – | |
Umbralisib + ublituximab | δ, CK1ε | [51] | I | 75 [19] | 3 | 44 [22] | NP | Neutropenia [28], PNA [8], diarrhea [8], abdominal pain [7], thrombocytopenia [5] | – |
Copanlisib + BR or R-CHOP | α/δ | NCT03711578 | III | NAc | NAc | NAc | NAc | NAc | – |
Duvelisib + nivolumab | δ/γ | NCT03892044 | I | NAc | NAc | NAc | NAc | NAc | – |
Idelalisib + pembrolizumab | δ | NCT02332980 | II | NAc | NAc | NAc | NAc | NAc | – |
Duvelisib + acalabrutinib | δ/γ | NCT04836832 | I/II | NAc | NAc | NAc | NAc | NAc | – |
Umbralisib + pembrolizumab | δ, CK1ε | NCT03283137 | I | NAc | NAc | NAc | NAc | NAc | – |
Umbralisib + ublituximab + lenalidomide | δ, CK1ε | NCT04635683 | I | NAc | NAc | NAc | NAc | NAc | – |