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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