bims-hemali Biomed News
on Hematologic malignancies
Issue of 2026–10–11
sixteen papers selected by
Alexandros Alexandropoulos, Γενικό Νοσοκομείο Αθηνών Λαϊκό



  1. Blood. 2026 Oct 06. pii: blood.2026034588. [Epub ahead of print]
      In this phase II trial, we evaluated the addition of the CD3xCD20 bispecific antibody, glofitamab (glofit) to polatuzumab, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) and an international prognostic index (IPI) ³ 2. Patients received two cycles of pola-R-CHP (one cycle of R-CHOP allowed). Glofitamab was added to pola-R-CHP during cycles 3 through 6 and used as monotherapy for cycles 7 and 8. The primary objective was the best complete response (CR) rate. A total of 41 patients enrolled. The median age was 61 years (range 35-86), and 59% were male. IPI scores were 2 (39%), 3 (41%), and 4 (20%), and 86% of patients had stage III/IV disease. Most patients had DLBCL, NOS (78%) and 12% had high grade B-cell lymphoma with translocations in MYC and BCL-2 and/or BCL-6. The best CR rate was 95% (39/41) (95% CI: 83-99) and both patients with a partial response at the end of therapy converted to CR without intervention. With a median follow-up of 23.9 months, the median progression-free survival (PFS) has not been reached and the 24-month PFS was 95% (95% CI: 89-100). Four (10%) patients developed cytokine release syndrome (CRS) (all grade 1), and no immune effector cell-associated neurotoxicity syndrome (ICANS) was reported. Glofit-pola-R-CHP resulted in high rates of CR and preliminary evidence of durable responses and the schedule, with delayed incorporation of glofit, resulted in low rates of CRS and no neurotoxicity. These data support further evaluation of this regimen. NCT05800366.
    DOI:  https://doi.org/10.1182/blood.2026034588
  2. Leukemia. 2026 Oct 06.
      Treatment-free remission (TFR) has become a major therapeutic goal in patients with chronic myeloid leukemia (CML). Japanese clinical and translational studies have contributed substantially to this field. Here, we review Japanese studies and distinguish between findings that corroborate internationally established concepts and those that provide novel biological insights. Confirmatory studies demonstrated the feasibility of TFR after sustained deep molecular response (DMR), established DMR duration as a more important determinant of durable remission than rapid attainment, and confirmed the feasibility of repeated discontinuation attempts. Together, these findings support the concept that sustained DMR provides sufficient time for both continued reduction of residual disease burden and progressive restoration of immune surveillance. Beyond these observations, Japanese studies have provided important mechanistic insights into leukemic stem cell persistence, dasatinib-associated immune remodeling, inherited immunogenetic determinants of TFR, adaptive immune surveillance, and practical biomarkers of TFR eligibility. Collectively, these findings support an integrated model of TFR in which inherited immunogenetic background, immune competence, leukemic stem cell persistence, and treatment history interact dynamically to determine clinical outcomes. Ongoing studies, including ASSET-CML and ASC4Edit Japan, may further translate these insights into more individualized and durable TFR strategies.
    DOI:  https://doi.org/10.1038/s41375-026-03155-2
  3. Blood. 2026 Oct 05. pii: blood.2026035116. [Epub ahead of print]
      Older or medically unfit patients with diffuse large B-cell lymphoma (DLBCL) frequently cannot tolerate standard anthracycline-based immunochemotherapy, creating a persistent unmet clinical need. We conducted a multicenter, international, open-label phase I/II trial evaluating an immunotherapy-based first-line approach using subcutaneous mosunetuzumab in combination with polatuzumab vedotin in previously untreated patients classified as unfit or frail by simplified geriatric assessment (sGA). Participants received six cycles of polatuzumab vedotin with step-up-dosing of subcutaneous mosunetuzumab, followed by mosunetuzumab monotherapy for a planned total of eight cycles. The primary endpoint was objective response rate (ORR) at end of treatment, assessed by independent review using PET-CT Lugano 2014 criteria. Among participants treated at full dose (n=101), the median age was 81 years with 58% classified as unfit and 41% as frail by sGA. The ORR at the end of treatment was 61.4% (95% CI, 51.1-70.9), with a complete response (CR) rate of 56.4%. The best observed ORR and CR rates on therapy were 80.2% and 66.3%, respectively. With a median follow-up of 36.5 months, median investigator-assessed duration of response and overall survival were not reached; estimated 2-year progression-free and overall survival were 52.2% and 62.4%, respectively. Cytokine release syndrome occurred in 30.6% of participants and was predominantly grade 1. Infection-related mortality was observed, largely during the COVID-19 pandemic and among participants classified as frail. This geriatric assessment-guided treatment demonstrated durable efficacy and may represent a potential first-line treatment option for carefully selected unfit or frail patients with newly diagnosed DLBCL. Trial registration: #NCT03677154.
    DOI:  https://doi.org/10.1182/blood.2026035116
  4. Haematologica. 2026 Oct 08.
      Older adults (OA, ≥60 years) with classic Hodgkin lymphoma (cHL) have historically experienced inferior outcomes compared to younger patients. Nivolumab in combination with doxorubicin, vinblastine, and dacarbazine (NAVD) has demonstrated high efficacy in clinical trials, but real-world data in OA are limited. We conducted a multicenter retrospective study across 20 centers in patients with newly diagnosed advanced stage cHL treated with NAVD and analyzed outcomes in OA across the aging spectrum. Among 327 total patients, 81 (25%) were ≥60 years, with most OA presenting with stage IV disease (58%) and B symptoms (57%). Anygrade and ≥grade 3 AEs occurred in 88% and 67% of OA, respectively. Prophylactic growth factors were used in most OA (82%) which led to low rates of febrile neutropenia (12%) and infection (12%) despite 52% ≥grade 3 neutropenia. Immune-related AEs occurred in 29% (12% ≥grade 3) and treatment was discontinued due to toxicity in 10% of OA. Interim overall (ORR) and complete response rates (CRR) were 100% and 81.6%, end-of-treatment rates were 88% and 82.6%, respectively. At a median follow-up of 12.6 months, 1-year progression-free survival (PFS) and overall survival (OS) in OA were 91.5% and 98.6%, respectively. OS was inferior in OA compared with patients.
    DOI:  https://doi.org/10.3324/haematol.2026.301545
  5. Blood. 2026 Oct 05. pii: blood.2026033293. [Epub ahead of print]
      TP53 loss-of-function (TP53-LoF) remains the single most important prognostic factor in chronic lymphocytic leukemia (CLL). Comprehensive assessment for TP53-LoF requires testing for both gene deletion and mutation. Historically, patients with TP53-LoF CLL have had poor outcomes and experienced short survival when treated with chemoimmunotherapy. In the novel agent era, multiple studies have demonstrated the effectiveness of continuous covalent BTK inhibitor (cBTKi) therapy, especially in the frontline setting, with a median progression-free survival (PFS) of approximately 7 years. Continuous cBTKi is therefore the de-facto standard for current management of TP53-LoF CLL. In contrast, fixed-duration regimens combining venetoclax with either obinutuzumab or cBTKi have shown slower response kinetics with longer time to undetectable minimal residual disease (uMRD) status, and reduced PFS, in patients with TP53-LoF CLL. Although early data from fixed-duration regimen studies indicate that most patients respond to retreatment, specific data for the TP53-LoF subset have not been reported. Therefore, the application of fixed-duration regimens for treatment of TP53-LoF CLL requires careful deliberation on the risks vs benefits of long-term cBTKi therapy, and acceptance of the uncertainty around the lack of granular retreatment outcomes. Multiple fixed-duration studies have shown that uMRD is a key endpoint in patients with TP53-LoF CLL. In this respect, clinical trials examining consolidation strategies in patients with detectable MRD, or in those with high-risk genomics, may be especially impactful in patients with TP53-LoF CLL.
    DOI:  https://doi.org/10.1182/blood.2026033293
  6. Exp Hematol. 2026 Oct 06. pii: S0301-472X(26)00551-5. [Epub ahead of print] 105918
      The human PROMININ-1 (PROM-1, CD133), detected by its AC133 epitope, is expressed on the surface of leukemia-initiating cells of Philadelphia chromosome-positive (Ph+) leukemia cells. Ninety-five percent of chronic myeloid leukemia (CML) cases are Ph+. Ph+ acute lymphoblastic leukemia (ALL) accounts for twenty-five to thirty percent of adult ALL and is considered a high-risk ALL subgroup. Targeting the t(9;22)-fusion protein BCR::ABL1 with ABL1-directed kinase inhibitors (TKIs) is a proven therapeutic concept for CML and Ph+ ALL. Resistance against TKI comprises mutations in BCR::ABL1, but many patients exhibit a primary resistance with unknown mechanisms. Here, we investigated the impact of PROM-1 on the leukemogenesis and the therapy response of Ph+ leukemias. We applied flow cytometry, co-immunoprecipitation, immunoblotting, stem cell assays, and leukemia induction in vivo to cell lines, syngeneic mouse models, and human Ph+ long-term cultures. We found a direct relationship between BCR::ABL1 and PROM-1, a shift from CML towards ALL upon the loss of Prom-1, as well as a link between the response to TKIs and the PROM-1 expression. In contrast to solid tumors, resistance was accompanied by a progressive loss of PROM-1. Our data suggest that PROM-1 plays an essential role in both cell fate decision and induction of the BCR::ABL1-related leukemic phenotype, highlighting its impact on the drug response of Ph+ leukemias. Teaser abstract The Philadelphia chromosome (Ph) is the product of the t(9;22), which fuses the BCR gene on chromosome 22 to the ABL1 gene on chromosome 9. The result is the BCR::ABL1 oncogene, which is responsible for the induction of chronic myeloid leukemia (CML) and for about a third of acute lymphoblastic leukemia (Ph+ ALL). Only little is known about how t(9;22) induces either CML or ALL, and why there is a difference between the two diseases regarding their response to inhibitors that can inactivate BCR::ABL1. Here, we show that a gene called PROMININ-1 is involved in both processes: determining whether BCR::ABL1 induces CML or ALL, and explaining the weaker response of Ph+ ALL compared to CML to inhibitors of BCR::ABL1. We found that the reduction of PROMININ-1 increased the proportion of ALL induced by BCR::ABL1 in the mouse. We could not reproduce these findings in humans but distinguish CML from Ph+ ALL by the expression of PROMININ-1. Also resistance to BCR::ABL1 inhibitors was associated with low expression of PROMININ-1 in Ph+ ALL. These findings are in contrast to observations in solid tumors where a higher level of PROMININ-1 is accompanied by therapy resistance. Our findings contribute to a better understanding of the different types of Ph+ leukemia and their response to therapy, which will help patients better manage these diseases.
    Keywords:  Acute Lymphoblastic Leukemia (ALL); BCR::ABL1; Chronic Myeloid Leukemia (CML); Philadelphia-chromosome (Ph+)-positive leukemia; cellular fate
    DOI:  https://doi.org/10.1016/j.exphem.2026.105918
  7. Onco Targets Ther. 2026 ;19 631781
       Background and Significance: Inhibition of both the phosphoinositide 3-kinase delta (PI3Kδ) pathway and Janus kinase (JAK) signaling decreases proliferation of cells from patients with myelofibrosis (MF). Roginolisib is a novel oral conformation-selective PI3Kδ inhibitor and when combined with JAK inhibitors it shows efficacy in primary progenitor cells isolated from MF patients. The biologically effective dose (BED) previously established at the daily 80 mg dose and corresponding to ≥90% target inhibition was well tolerated during the first-in-human (FiH) dose study. This dose of roginolisib was combined with approved JAK inhibitors in MF patients who no longer responded to JAK inhibition.
    Study Design and Methods: The HEMA-MED trial (NCT06887803) is a prospective, multi-center Phase 1/2 study. The primary objective of this study is to evaluate the tolerability of roginolisib when combined with an approved JAK inhibitor in MF patients. Secondary objectives include: (a) changes in peripheral blood Tregs; (b) splenic response rate (SRR); (c) proportion of patients with a reduction in Total Symptom Score (TSS) as measured by Myelofibrosis Symptom Assessment Form (modified MFSAF version 4). Key Inclusion criteria: (1) diagnosis of primary MF; (2) prior treatment with approved JAK inhibitors for ≥3 months and on a stable dose for ≥1 month prior to starting the add-on treatment. Furthermore, patients must show an unsatisfactory spleen reduction; (3) active symptoms of MF as demonstrated by the presence of a TSS of ≥10; (4) platelet count ≥ 50 × 109/L and haemoglobin ≥8 g/dL. The study is actively enrolling at 17 sites in Italy, Spain and United Kingdom.
    Conclusion: Given the safety profile of roginolisib as monotherapy in patients of the FiH study, the combination of a JAK inhibitor (eg, ruxolitinib) and roginolisib is expected to provide a well-tolerated treatment in patients with MF who are no longer responding to JAK inhibition.
    Keywords:  IOA-244; JAK1/2 inhibition; PI3Kdelta; momelotinib; myelofibrosis; resistance mechanism; roginolisib; ruxolitinib
    DOI:  https://doi.org/10.2147/OTT.S631781
  8. Blood Adv. 2026 Oct 06. pii: bloodadvances.2026022335. [Epub ahead of print]
      Multiple myeloma (MM) is monitored using bone marrow-based minimal residual disease (MRD) assays, which provide high sensitivity but require repeated invasive sampling and are limited to a single anatomical site. Cell-free DNA (cfDNA) offers a minimally invasive alternative, yet most cfDNA approaches rely on prior tumor profiling to identify patient-specific genomic alterations for subsequent tracking in plasma. Here, we developed MATADOR, a myeloma-specific, tumor-agnostic framework that leverages cfDNA fragmentation patterns at a fixed set of myeloma-specific chromatin-accessible regulatory regions. These regions were defined using single-nucleus ATAC-seq data from an independent MM cohort and used to quantify plasma cfDNA fragmentation at these loci without patient-specific tumor profiling. Using these locus-specific features alone, MATADOR distinguished clinically measurable from unmeasurable disease in a held-out test set with an area under the receiver operating characteristic curve (AUROC) of 0.94. These findings establish chromatin-informed cfDNA fragmentomics as a minimally invasive approach for disease assessment in MM without individualized tumor profiling, enabling blood-based assessment of disease beyond the constraints of bone marrow sampling.
    DOI:  https://doi.org/10.1182/bloodadvances.2026022335
  9. Leukemia. 2026 Oct 06.
      Approximately 96% of myelofibrosis (MF) patients express wild-type (WT) p53. MF hematopoietic stem/progenitor cells (HSPCs) overexpress MDM2 that degrades WTp53, thereby supporting MF HSPC survival. Although MDM2 small-molecule inhibitors (SMIs) are clinically effective, their benefit is compromised by an inability to sufficiently deplete MF HSPCs. KT-253 degrades MDM2 and overcomes the p53-dependent feedback loop that restores MDM2 levels observed with the use of MDM2 SMIs such as AMG-232. We evaluated the effects of KT-253 using MPN cell lines, primary MF CD34+ cells, and a mouse xenograft model. KT-253 activity was correlated with activation of the p53 pathway and upregulation of p53 downstream genes, including p21, NOXA, and PUMA in WTp53 UKE-1 cells but not p53 mutant cells. KT-253 treatment induced apoptosis of primary MF CD34+ cells at a tenfold lower concentration than AMG-232 and prevented the upregulation of MDM2 seen with AMG-232. Low doses of KT-253 reduced total MF colony and JAK2V617F+ colony numbers to a far greater extent than log-higher doses of AMG-232 (60% and 71% versus 20% and 10%, respectively). Mouse xenograft studies indicated that KT-253 more effectively depleted JAK2V617F+ MF marrow-repopulating cells. These findings support the further clinical evaluation of MDM2 degraders for the treatment of MF patients.
    DOI:  https://doi.org/10.1038/s41375-026-03163-2
  10. Leuk Res. 2026 Oct 01. pii: S0145-2126(26)00178-5. [Epub ahead of print]171 108334
      Angioimmunoblastic T-cell lymphoma (AITL) is a peripheral T-cell lymphoma (PTCL) that originates from follicular helper T cells (Tfh) and represents a rare subtype of non-Hodgkin lymphoma (NHL). The disease is characterized by unique morphological, molecular, and clinical features, and exhibits aggressive behavior. Currently, there is no standard treatment protocol, and patients treated with first-line CHOP-like chemotherapy show low remission rates, high recurrence rates, and poor overall prognosis. In recent years, with the in-depth study of the molecular genetic mechanism of AITL, various novel therapies have shown potential in patients with relapsed/refractory (R/R) AITL. This review aims to summarize the latest developments in the molecular mechanisms and treatment strategies of AITL, with the goal of providing references for clinical practice.
    Keywords:  Angioimmunoblastic T-cell lymphoma; Epigenetics; Pathogenesis; Prognosis; Treatment; Tumor microenvironment
    DOI:  https://doi.org/10.1016/j.leukres.2026.108334
  11. J Hematol Oncol. 2026 Oct 07. pii: 81. [Epub ahead of print]19(1):
      The management of acute myeloid leukemia (AML) has undergone a remarkable transformation over the past decade, as advances in genomic profiling and drug development have expanded therapeutic options and enabled increasingly personalized treatment approaches. This review summarizes the evolving therapeutic landscape of AML, including current intensive and lower-intensity treatment backbones, approved molecularly targeted therapies, and emerging investigational strategies. We discuss the role of intensive cytarabine plus anthracycline-based regimens and venetoclax-based lower-intensity approaches, as well as targeted therapies directed against FLT3, IDH1/2, NPM1, and KMT2A-rearranged AML. We further examine efforts to optimize existing treatment paradigms through the incorporation of venetoclax into intensive chemotherapy, rational targeted combinations, and novel triplet regimens, in addition to the emerging use of highly active lower-intensity therapies in younger fit patients. Finally, we highlight promising future directions in AML, including therapies targeting RAS/MAPK signaling, emerging approaches for TP53-mutated disease, and immunotherapeutic strategies. AML treatment is rapidly evolving from broadly applied chemotherapy-based approaches toward increasingly molecularly informed and individualized therapeutic strategies. Continued advances in molecular diagnostics, targeted therapies, and synergistic combination regimens have the potential to further increase remission durability, reduce relapses, and improve long-term outcomes for patients with AML.
    Keywords:  AML; Acute myeloid leukemia; Measurable residual disease; Precision medicine; Targeted therapy; Venetoclax
    DOI:  https://doi.org/10.1186/s13045-026-01849-9
  12. Front Immunol. 2026 ;17 1915205
       Rationale: Antibody recruiters are an innovative class of immunotherapeutics, comprising a tumor-binding module and an antibody-binding module to redirect endogenous antibodies toward target cells. Recruited antibodies can then induce Fc-dependent effector functions to lyse tumor cells. The clinical success of CD38-directed monoclonal antibodies daratumumab and isatuximab has established CD38 as a validated target for the treatment of multiple myeloma (MM). Since daratumumab treatment can result in antigen loss or mutation of the binding site, novel immunotherapeutics should explore different binding mechanisms for maximum efficacy. Here, we report the generation of CD38-specific trimeric antibody recruiters (CD38-STARs) using nanobodies, single variable immunoglobulin domains isolated from camelid heavy-chain antibodies.
    Methods: We genetically fused two different CD38-specific nanobodies against distinct CD38 epitopes to a human immunoglobulin κ light chain-specific nanobody to generate two CD38-STARs (E2-E3-STAR and E3-E2-STAR) with biparatopic antigen-binding modules. We analyzed their CD38 binding characteristics and the capacity for simultaneous engagement of CD38 and IgG, IgM, or IgA. We evaluated the induction of complement-dependent cytotoxicity (CDC) against various CD38-expressing tumor cell lines in vitro and against primary MM patient cells ex vivo, comparing the CD38-STARs with monoparatopic bispecific antibody recruiters (BARs).
    Results: Both CD38-STARs engaged CD38 by simultaneously binding two epitopes that are distinct from the epitope bound by daratumumab, resulting in improved avidity compared to monoparatopic CD38-specific BARs. CD38-STARs demonstrated concurrent binding to CD38 and human IgG, IgM, or IgA. CD38-STARs induced higher CDC against various CD38-expressing tumor cell lines in vitro compared to monoparatopic BARs or daratumumab. Ex vivo, CD38-STARs mediated significant CDC induction against primary myeloma cells, whereas monoparatopic BARs failed to achieve significant killing.
    Conclusion: Biparatopic targeting of CD38 using CD38-STARs represents a promising strategy for the treatment of MM, including the rare cases in which daratumumab fails to bind due to CD38 mutations.
    Keywords:  CD38; antibody recruiting molecules; avidity; biparatopic; bispecific engagers; complement-dependent cytotoxicity; multiple myeloma; nanobodies
    DOI:  https://doi.org/10.3389/fimmu.2026.1915205
  13. Hemasphere. 2026 Oct;10(10): e70499
      Erdheim-Chester disease (ECD) is a rare histiocytic neoplasm characterized by heterogeneous clinical manifestations and limited evidence to guide targeted therapy. While MEK inhibitors (MEKi) are increasingly used, data on their real-world efficacy, durability, and safety remain incomplete. We analyzed outcomes of patients with ECD treated with MEKi monotherapy across eight countries and assessed the dynamics and predictors of response, treatment retention, and the safety profile of MEKi. We included 170 patients and were able to evaluate response in 159 (94%) of them. Objective responses were observed in 112 patients (70%), disease stabilization in 35 (22%), and disease progression in 12 (8%). Response rates were independent of treatment lines and underlying molecular alterations. The median time to best response was 14 months, with an estimated 2-year probability of response of 61% (95% CI 51%-67%). In multivariable analysis, dyslipidemia (odds ratio [OR] 0.359, 95% CI 0.171-0.745) and neurodegeneration (OR 0.354, 95% CI 0.144-0.864) were associated with a lower probability of response to MEKi, while cutaneous and gastrointestinal involvement with a higher probability. After a median follow-up of 27 months (interquartile range [IQR] 12-57), the treatment retention rate was 76%, with most discontinuations attributable to toxicity. Adverse events were reported in 106 patients (62%) and were severe in 39 patients (23%). The estimated 2-year event-free survival was 65% (95% CI 57%-72%), and the estimated 2-year overall survival was 80% (95% CI 72%-86%). MEKi monotherapy provides robust and durable clinical efficacy in patients with ECD, with high response rates and favorable long-term outcomes, despite a substantial burden of toxicity.
    DOI:  https://doi.org/10.1002/hem3.70499