Table 3.

Mitigation strategies used in BsAb clinical trials and resulting CRS rates

Trial IDN.Histology, settingDrug(s)RouteFull dose, mgMitigation strategies during C1% CRS % serious CRS% toci use
SUDHosp∗Other G1G2G3G4G5
NCT03677154 29 DLBCL, ND MOSUN IV 13.5 (8), 30 (21) Yes Mandatory  17 NR 
NCT02500407 197 Mixed, R/R MOSUN IV 2.8-40.5 Yes§  Optional only in exp. cohorts  21 1.5 
90 FL, R/R MOSUN IV 30 Yes Optional  26 17 1  NR 7.8 
39 Mixed, R/R MOSUN SC 45 Yes Optional  11 178 10.3 
27 Mixed, R/R MOSUN, rapid SUD SC 45 Yes Optional  33 
NCT03075696 258 Mixed, R/R GLOFIT IV 0.6-30 Yes§  Mandatory Obin  31 23 36 20% at RP2D 
155 DLBCL, R/R GLOFIT IV 30 Yes Mandatory Obin  47 12 NR 32 
24 FL, R/R GLOFIT IV 16 (3), 30 (21) Yes Mandatory Obin  63 13 50 8.3 
29 FL, R/R GLOFIT, ext. SUD IV 30 Yes Mandatory Obin  35 21 31 21 
19 FL, R/R GLOFIT-obin IV 30 Yes Mandatory Obin  53 26 26 26 
29 MCL, R/R GLOFIT IV 0.6-30 Yes§  Mandatory Obin  35 21 38 24 
NCT03625037 68 Mixed, R/R EPCOR SC 0.0128-60 Yes§  Mandatory Post-dose CS 29 29 NR 
157 LBCL, R/R EPCOR SC 48 Yes Mandatory Post-dose CS 32 15 NR 14 
NCT04082936 40 Mixed, R/R IgM2323 IV 0.5-1000 Yes§  Mandatory  18 NR NR 
NCT02924402 64 Mixed, R/R PLAMO IV 0.7-450ug/Kg, or 50 Yes§  NR  19 33 <1 <1 NR NR 
NCT02290951 145 Mixed, R/R ODRON IV 0.5-320 Yes Mandatory Split-dose 36 18 NR NR 
NCT03677141 40 DLBCL, ND MOSUN-CHOP IV 30 Yes NR  40 13 NR 
NCT03467373 31 Mixed, R/R GLOFIT-R-CHOP IV 0.07-30 Yes§  Mandatory GLOFIT from C2 32 13 10 26 26 
26 DLBCL, ND GLOFIT-R-CHOP IV 30 Yes Mandatory GLOFIT from C2 
NCT04663347 24 DLBCL, ND EPCOR-R-CHOP SC 24 (4), 48 (20) Yes Mandatory Post-dose CS 17 17 NR NR 
29 DLBCL, R/R EPCOR-R-DHAX SC 48 Yes Mandatory Post-dose CS 38 28 10 NR 
26 DLBCL, R/R EPCOR-GemOx SC 48 Yes Mandatory Post-dose CS 27 38 NR 19 
NCT03671018 63 DLBCL (60), FL (3), R/R MOSUN-pola IV 30 Yes Optional  16 
NCT03533283 59 Mixed, R/R GLOFIT-pola IV 10 (6), 30 (53) Yes NR GLOFIT from C1D8 29 12 24 11.9 
NCT04246086 29 FL, R/R MOSUN-len IV 30 Yes Optional  24 14 
NCT04663347 29 FL, R/R EPCOR-R-len SC 2 (3), 48 (26) Yes Mandatory Post-dose CS 28 14 NR NR 
Trial IDN.Histology, settingDrug(s)RouteFull dose, mgMitigation strategies during C1% CRS % serious CRS% toci use
SUDHosp∗Other G1G2G3G4G5
NCT03677154 29 DLBCL, ND MOSUN IV 13.5 (8), 30 (21) Yes Mandatory  17 NR 
NCT02500407 197 Mixed, R/R MOSUN IV 2.8-40.5 Yes§  Optional only in exp. cohorts  21 1.5 
90 FL, R/R MOSUN IV 30 Yes Optional  26 17 1  NR 7.8 
39 Mixed, R/R MOSUN SC 45 Yes Optional  11 178 10.3 
27 Mixed, R/R MOSUN, rapid SUD SC 45 Yes Optional  33 
NCT03075696 258 Mixed, R/R GLOFIT IV 0.6-30 Yes§  Mandatory Obin  31 23 36 20% at RP2D 
155 DLBCL, R/R GLOFIT IV 30 Yes Mandatory Obin  47 12 NR 32 
24 FL, R/R GLOFIT IV 16 (3), 30 (21) Yes Mandatory Obin  63 13 50 8.3 
29 FL, R/R GLOFIT, ext. SUD IV 30 Yes Mandatory Obin  35 21 31 21 
19 FL, R/R GLOFIT-obin IV 30 Yes Mandatory Obin  53 26 26 26 
29 MCL, R/R GLOFIT IV 0.6-30 Yes§  Mandatory Obin  35 21 38 24 
NCT03625037 68 Mixed, R/R EPCOR SC 0.0128-60 Yes§  Mandatory Post-dose CS 29 29 NR 
157 LBCL, R/R EPCOR SC 48 Yes Mandatory Post-dose CS 32 15 NR 14 
NCT04082936 40 Mixed, R/R IgM2323 IV 0.5-1000 Yes§  Mandatory  18 NR NR 
NCT02924402 64 Mixed, R/R PLAMO IV 0.7-450ug/Kg, or 50 Yes§  NR  19 33 <1 <1 NR NR 
NCT02290951 145 Mixed, R/R ODRON IV 0.5-320 Yes Mandatory Split-dose 36 18 NR NR 
NCT03677141 40 DLBCL, ND MOSUN-CHOP IV 30 Yes NR  40 13 NR 
NCT03467373 31 Mixed, R/R GLOFIT-R-CHOP IV 0.07-30 Yes§  Mandatory GLOFIT from C2 32 13 10 26 26 
26 DLBCL, ND GLOFIT-R-CHOP IV 30 Yes Mandatory GLOFIT from C2 
NCT04663347 24 DLBCL, ND EPCOR-R-CHOP SC 24 (4), 48 (20) Yes Mandatory Post-dose CS 17 17 NR NR 
29 DLBCL, R/R EPCOR-R-DHAX SC 48 Yes Mandatory Post-dose CS 38 28 10 NR 
26 DLBCL, R/R EPCOR-GemOx SC 48 Yes Mandatory Post-dose CS 27 38 NR 19 
NCT03671018 63 DLBCL (60), FL (3), R/R MOSUN-pola IV 30 Yes Optional  16 
NCT03533283 59 Mixed, R/R GLOFIT-pola IV 10 (6), 30 (53) Yes NR GLOFIT from C1D8 29 12 24 11.9 
NCT04246086 29 FL, R/R MOSUN-len IV 30 Yes Optional  24 14 
NCT04663347 29 FL, R/R EPCOR-R-len SC 2 (3), 48 (26) Yes Mandatory Post-dose CS 28 14 NR NR 

The table separates single-agent studies (upper portion) from combination studies (lower portion). Data generally refer to the CRS episode with highest frequency and/or of the highest grade following BsAb dosing. These varied among trials. Virtually all patients received acetaminophen, antihistamine, and corticosteroids premedication. The distinction between CTCAE-defined infusion-related reaction and CRS was either not explicitly made or left at the treating physician's discretion, thus it is possible that the true incidence of CRS be different than reported in some studies.

C, cycle; CS, corticosteroids; (D)LBCL, (diffuse) large B-cell lymphoma; EPCOR, epcoritamab; esc, escalation; exp, expansion; FL, follicular lymphoma; GLOFIT, glofitamab; G, grade; len, lenalidomide; hosp, hospitalization; MCL, mantle cell lymphoma; MOSUN, mosunetuzumab; ND, newly diagnosed, NR, not reported; obin, obinutuzumab; ODRON, odronextamab; PLAMO, plamotamab; pola, polatuzumab, RP2D, recommended phase-2 dose; R/R relapsed/refractoy; SC, subcutaneous; SUD, step-up dosing; toci, tocilizumab.

Prescribed on the day of expected highest risk of CRS.

In all reported studies, corticosteroids were used as part of the premedication during cycle 1 and, in some cases cycle 2.

Incidence as reported by authors, separately reported single components are not listed in this table.

§

Performed in only part of the study population, for example, at certain dose levels or in expansion cohorts only.

Patient with leukemic phase FL.

Generally administered on cycle 1, day 7; defined according to the ASBMT consensus criteria.

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