Table 1.

Warnings and Grade ≥ 3 AEs for Approved and Emerging PI3K Inhibitors for Indolent NHL^6,15,17–19

	Copanlisib	Idelalisib	Duvelisib	Umbralisib
MoA	PI3Ki (α, δ)	PI3Ki (δ)	PI3Ki (δ,γ)	PI3Ki (δ), cMyc
Black Box warning	None	Fatal and/or serious toxicities: Hepatotoxicity (11%–18%) Severe diarrhea or colitis (14%–19%) Pneumonitis (4%) Infections (21%–36%) Intestinal perforation	Fatal and/or serious toxicities: Diarrhea or colitis (18%) Cutaneous reactions (5%) Infections (31%) Pneumonitis (5%)	N/A
Grade ≥ 3 AEs (in patients with FL unless otherwise noted)b
Hyperglycemia	40% (infusion-related)	N/A	N/A	N/A
Hypertension	27% (infusion-related)	N/A	N/A	N/A
Pneumonitis	1%	16%d	5%f	< 1.5%a
Lung infection	16%		16%e	5%e
Diarrhea	5%	14%	18%	3%
Colitis	1%c			< 1.5%a
ALT increased	1.4%	18%	18%	3%
AST increased	1.4%	12%	12%	3%

Abbreviations: AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; FL = follicular lymphoma; MoA = mechanism of action; N/A = not available; NHL = non-Hodgkin lymphoma.

Table is for comparison purposes only. There are no clinical data comparing any of these drugs.

^aAll grades.

^bFor copanlisib, AEs reported are for patients with FL and other hematologic malignancies.

^cPatient had medical history of diverticulosis.

^dIncludes patients with pneumonia, other lung infections, or pneumonitis.

^ePneumonia only.

^fReported as severe events.