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Table 1 PI3K inhibitors in FL (includes completed and ongoing trials)

From: Evolving therapeutic landscape in follicular lymphoma: a look at emerging and investigational therapies

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 [39, 40] II 142 [104] 3 59 [20] 12.5 Hyperglycemia [40], Hypertension [24], Neutropenia [24]  + 
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 Neutropenia [11], diarrhea [10], LFT rise [7]  + 
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 Neutropenia [41], rash [20], diarrhea [13]
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
  1. Abbreviations: AEs—adverse events; BR—bendamustine and rituximab; CR—complete response rate; NP—not presented; ORR—overall response rate; PFS—progression-free survival; PNA—pneumonia; R-CHOP—rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
  2. aResponse rates for FL subset
  3. bGrade ≥ 3 seen in at least 5% of all patients regardless of lymphoma subtype
  4. cNot available, clinical trials are either ongoing or underway
  5. dResults are for NHL, FL specific results were not presented due to the small number of pts