Besponsa (inotuzumab ozogamicin)

Inotuzumab ozogamicin showed high activity as reinduction treatment in paediatric very high risk first B-cell acute lymphoblastic leukaemia relapse and a favourable toxicity profile with no treatment-related deaths.

P2, N=32, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China

P2, N=25, Recruiting, University of Chicago | Suspended --> Recruiting | Trial completion date: Mar 2027 --> Mar 2028 | Trial primary completion date: Mar 2027 --> Mar 2028

There were no other notable differences in T-cell phenotype or markers of exhaustion among the subset of samples with extended flow cytometry panels. With the exception of lower CD4:CD8 ratios in patients with prior inotuzumab, the comparable apheresis yield and composition observed after immunotherapy exposure is a reassuring finding, particularly in light increased use of upfront blinatumomab for B-ALL.

The patient achieved complete hematological remission after one cycle of dasatinib combined with hyper-CVAD/MA. Measurable residual disease persisted, and he underwent two cycles of inotuzumab ozogamicin therapy followed by allogeneic hematopoietic stem cell transplantation. This case highlights the critical need for vigilant follow-up in CML patients after prolonged TFR, given the risk of progression to blast crisis.

Notably, in the triplet combination of IO with P-gp and PARP inhibitors, PARP inhibition of the repair of DNA damage caused by calicheamicin accumulation following P-gp inhibition markedly enhanced the antitumor effects of IO. This approach may offer a novel and effective therapeutic strategy for IO-resistant B-ALL.

P3, N=750, Not yet recruiting, Charite University, Berlin, Germany

CD22-targeted therapies, including CD22 CAR-T cells and Inotuzumab Ozogamicin, show promise as alternatives, although data in those patients is limited...Among these patients, 27.9% received blinatumomab, 58.1% received CD19 CAR-T cells, and 14% received both...Patients with extramedullary disease had worse remission rates, and those previously resistant to CD19-targeted therapy had shorter RFS. CD22-targeted therapies offer a potential option for patients progressing after CD19-targeted immunotherapy, but high relapse rates highlight the need for better strategies for lasting remission.

Median time to hepatotoxicity improvement after InO discontinuation was 18 days, and no patients progressed to SOS.ConclusionCalicheamicin Syndrome represents a reproducible and reversible hepatotoxic entity distinct from SOS, characterized by InO exposure, transaminitis, thrombocytopenia, abnormal hepatic imaging, and HSC on pathology. Early recognition may facilitate monitoring and prevent progression to severe hepatic injury.

P2, N=68, Active, not recruiting, Alliance for Clinical Trials in Oncology | Trial completion date: May 2028 --> May 2029 | Trial primary completion date: May 2026 --> Apr 2027

P2, N=25, Suspended, University of Chicago | Recruiting --> Suspended

P2, N=84, Recruiting, National Cancer Institute (NCI) | N=64 --> 84