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Caution: inotuzumab before transplant (veno-occlusive disease)

The CD22 ADC is an excellent bridge to transplant, but too many cycles or the wrong conditioning can cause severe liver damage after the transplant.

VOD occurred in 22% of INO-VATE patients who proceeded to transplant; risk rises with >2 cycles, dual-alkylator conditioning, and prior hepatic injury. Guidance: limit to 2 cycles pre-transplant, avoid busulfan-thiotepa, consider defibrotide prophylaxis.

Inotuzumab ozogamicin⚠ withAllogeneic stem cell transplantationcaution
Rationale
Calicheamicin damages hepatic sinusoidal endothelium, which is then further injured by conditioning chemotherapy.
Evidence
INO-VATE safety data; label boxed warning.

Key papers

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rctNew England Journal of Medicine 2016changed practice
INO-VATE: inotuzumab ozogamicin, a CD22 antibody-drug conjugate, versus chemotherapy for relapsed adult B-cell ALL

INO-VATE made inotuzumab a standard salvage therapy for adult ALL and a common route to transplant, and, with the TOWER trial of blinatumomab, moved adult ALL from chemotherapy-only salvage to immunotherapy. Both drugs have since been pulled into front-line regimens. The liver toxicity signal shaped how transplant conditioning is chosen after inotuzumab.

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cancers

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Acute lymphoblastic leukaemia

technologies

1
Allogeneic stem cell transplantation

drugs

1
ApprovedADC
Inotuzumab ozogamicin · Besponsa

key papers

1
INO-VATE: inotuzumab ozogamicin, a CD22 antibody-drug conjugate, versus chemotherapy for relapsed adult B-cell ALL