Delving into the Latest Updates on Inotuzumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms-

Target

CD22

Action

inhibitors

Mechanism

CD22 inhibitors(CD22 inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Neoplasms

Inactive Indication-

Originator Organization

Pfizer Inc.

Active Organization

Pfizer Inc.

Inactive Organization-

License Organization-

Drug Highest PhaseClinical

First Approval Date-

Regulation-

Structure/Sequence

Sequence Code 9923006L

Source: *****

Sequence Code 9923033H

Source: *****

Adult ALL is typically treated with intensive chemotherapy although novel agents like blinatumomab and inotuzumab remain largely inaccessible in low- and middle-income countries (LMICs). Early mortality (EM) during induction is substantially higher in LMICs (10%-25%) than in high-income countries (<5%). This study aimed to identify EM risk factors in patients with adult ALL in LMICs to guide context-specific interventions.

METHODS:

A retrospective cohort study analyzed patients 15 years and older with newly diagnosed ALL between 2009 and 2023, regardless of the phenotype or Philadelphia status. EM was defined as death within 30 days of diagnosis.

RESULTS:

Among 203 patients (median age 36 years), the overall EM was 9.8% and 7.9% was younger than 50 years. Univariate analysis identified positive cerebral spinal fluid, cyclophosphamide during the prephase, low albumin, and obesity as associated with higher EM. In multivariable models, predictors of EM for the full cohort included age, albumin, cyclophosphamide use, and obesity. In patients 50 years and younger, only albumin and cyclophosphamide remained significant. After induction, 51.2% achieved complete response; 17.3% was unevaluable because of complications or death. Infection was common (72.9%). Sociodemographic variables were not associated with EM.

CONCLUSION:

EM was elevated, reflecting LMIC-specific challenges like late diagnosis and limited supportive care. Low albumin and prephase cyclophosphamide use were strongly linked to EM, likely via increased immunosuppression and infection risk. Findings stress the need for locally adapted protocols and simple risk markers to reduce EM in adult ALL.

28 Jan 2026·LEUKEMIA & LYMPHOMA

Mini-hyper CVD-inotuzumab with asciminib as salvage therapy for ponatinib-refractory Ph + B-ALL and CML lymphoid blast crisis

Article

Author: Dua, Vikas ; Nathany, Shrinidhi ; Swaminathan, Anusha ; Danewa, Arun ; Rastogi, Neha ; Bhargava, Rahul ; Kumar, Nikhil M. M.

01 Dec 2025·ANNALS OF PHARMACOTHERAPY

Revumenib for Relapsed or Refractory Acute Leukemia With a KMT2A Translocation

Review

Author: Faro, Sarah Jane E. ; Lynch, Emilie J. ; Lindstrom, Alec M. ; Sethi, Nadia A. ; Seligson, Nathan D. ; Wang, Wendy Y.

Objective::

To review the pharmacology, efficacy, and safety of revumenib (Revuforj) for relapsed or refractory (r/r) acute leukemia with a lysine methyltransferase 2A ( KMT2A) gene rearrangement or translocation ( KMT2Ar ).

Data Sources::

A literature search was conducted using PubMed/MEDLINE, applicable published abstracts, and ongoing studies from ClinicalTrials.gov between January 1, 1981, and April 23, 2025. Keywords included Revuforj, revumenib, SNDX-5613, KMT2A , MLL1 , and menin.

Study Selection and Data Extraction::

All English-language studies involving revumenib for r/r acute leukemia with a KMT2Ar were included.

Data Synthesis::

Revumenib, a protein-protein inhibitor that interrupts the interaction between the KMT2A protein and the scaffold protein menin, was granted approval by the Food and Drug Administration (FDA) for r/r acute leukemia with KMT2Ar based on a phase 2 clinical trial in adult and pediatric patients (n = 57), which reported a complete remission or complete remission with partial hematologic recovery of 22.8%. Common grade 3/4 adverse reactions reported for revumenib include infectious (febrile neutropenia 33%; infection 29%; bacterial infection 20%) and hematologic events (differentiation syndrome 13%; hemorrhage 9%; thrombosis 5%). Grade 3/4 QT prolongation, the primary dose-limiting adverse effect, was present in 12% of patients. Differentiation syndrome, related to revumenib’s antileukemic effect, was observed in 29% of patients (grade 3/4: 13%; grade 5: <1%). We also include long-term follow-up for a total of 104 and 135 patients for efficacy and safety results, respectively.

Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs::

In the high-risk disease of r/r acute leukemia with KMT2Ar , given limited treatment options, revumenib appears to be a viable, novel treatment option demonstrating clinical efficacy and a manageable adverse effect profile that can be utilized as a bridge to stem cell transplant. Existing therapy options in this setting may include additional traditional chemotherapy, chimeric antigen receptor T-cell therapy (CAR-T), antibody-drug conjugates (eg, gemtuzumab, inotuzumab), bispecific T-cell engager (BiTE) therapies (eg, blinatumomab), DNA methyltransferase inhibitors (eg, azacitidine, decitabine), histone deacetylase inhibitors (eg, vorinostat, panobinostat), and BCL-2 inhibitors (venetoclax).

Conclusions::

Revumenib is an innovative targeted treatment with promising activity in r/r acute leukemia with KMT2Ar .

100 Deals associated with Inotuzumab

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Clinical	-	Pfizer Inc.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PS1377 (EHA2025)	Not Applicable	Refractory B Acute Lymphoblastic Leukemia CD22	68	Inotuzumab Ozogamicin (INO)	ywuagdsoai(rngmxgwkqm) = Hematologic toxicity occurred in all patients, with 52.9% experiencing grade 3-4 events jlhzuchnkz (kvaplbaypy ) View more	Positive	14 May 2025
PB2350 (EHA2025)	Not Applicable	Recurrent Childhood Acute Lymphoblastic Leukemia CD22 expression	26	Inotuzumab 1 mg/m^2	jiuwxcnlef(dktrrgotph) = wpullcafuu byawinbnvz (wkzakuijya ) View more	Positive	14 May 2025
PB2350 (EHA2025)	Not Applicable		26	Inotuzumab 1.2 mg/m^2	jiuwxcnlef(dktrrgotph) = blcajcfnrg byawinbnvz (wkzakuijya ) View more	Positive	14 May 2025
PF1161 (EHA2025)	Not Applicable	Refractory B Acute Lymphoblastic Leukemia	73	Inotuzumab-based regimen	kqryvxaoeg(ehrkjxyqmd) = xqmfqmftye pwgyluaeaq (szrswjilxr ) View more	Positive	14 May 2025
PF1161 (EHA2025)	Not Applicable	Refractory B Acute Lymphoblastic Leukemia	73	Tali-cel infusion	yrmxwwxboi(nrdnbxggjv) = rorqcofmcr yinorsixhp (glxqkcxfgv, 1 - 74)	Positive	14 May 2025
ASH2024	Not Applicable	Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia	-	Inotuzumab	koiazaaxrw(aprkeyqmvc) = cksfninqna uzhyaeigzr (thwwfwzaeg ) View more	-	07 Dec 2024
ALL-808 (SOHO2024)	Phase 2	Recurrent Childhood Acute Lymphoblastic Leukemia	22	Mini-Hyper-CVD-Inotuzumab-Blinatumomab	hnjdrwbnmb(agdvjzpuwy) = rojjqfyacz wuccgvetgg (ckkthyazkh ) View more	Positive	04 Sep 2024
EHA2023	Not Applicable	Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	21	Two-dose regimen of inotuzumab	xruxwfkiev(yzrrbjsqoe) = Grade 1-3 hepatotoxicity occurred in 5 cases (23.8%) ebwgnphbjx (pdqqftdmpr )	-	08 Jun 2023
EHA2023	Phase 2	Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia	83	Mini-Hyper-CVD-Inotuzumab	yssvdctymc(wcoxknrjjw) = pcqmgnyqyn knypbfcwkl (egahfoabbw ) View more	-	08 Jun 2023
EHA2023	Phase 2		83	Mini-Hyper-CVD-Inotuzumab+Blinatumomab	jybvebbcky(wkjuahifre) = ooqycgyurf trvudjdhua (xnzlmcolfy ) View more	-	08 Jun 2023

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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