Besponsa (inotuzumab ozogamicin)

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

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

In this context, monoclonal antibodies such as blinatumomab and inotuzumab ozogamicin (InO), used alone or in combination with reduced-intensity chemotherapy, have emerged as promising frontline approaches capable of deep remissions with improved tolerability. Across all treatment strategies, comprehensive geriatric assessment appears more informative than performance status alone in predicting tolerability and outcome, supporting its integration into trial design and routine decision-making. Overall, the refinement of immunotherapeutic approaches, coupled with biologically and geriatrically tailored treatment algorithms, offers the most promising avenue to improve long-term outcomes for older patients with ALL.

P2, N=20, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China

P3, N=310, Suspended, Alliance for Clinical Trials in Oncology | Trial completion date: Aug 2026 --> Aug 2027 | Trial primary completion date: Mar 2026 --> Mar 2027

Currently, most leukemias are effectively treated with immunotherapies (highly effective monoclonal antibodies targeting CD19 [blinatumomab], or CD22 [inotuzumab ozogamicin]), BCR::ABL1 tyrosine kinase inhibitors (TKIs; e.g., dasatinib, ponatinib), Bruton TKIs (e.g., ibrutinib, acalabrutinib), BCL-2 inhibitors (venetoclax), IDH1/2 inhibitors (ivosidenib, olutasidenib, and enasidenib), FLT3 inhibitors (e.g., midostaurin, quizartinib, and gilteritinib), menin inhibitors (revumenib, ziftomenib), and chimeric antigen receptor T-cell therapies. Herein, we provide a high-level overview of prominent clinical developments across all leukemias. In contemporary times, harnessing the benefits of novel targeted therapies and the evolving treatment landscape bolster the optimistic view that most, if not all, leukemias are curable.

Despite recent advancements, patients with B-cell ALL tend to have poorer outcomes, especially in the adult population. Future research and larger scale prospective studies are indicated to evaluate the efficacy of InO in different lines of therapy.

P2/3, N=765, Not yet recruiting, Charite Universitaetsmedizin Berlin KR