Onco-Summaries: Daily Oncology Updates at a Glance

30/06/2026

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• BRUKINSA + rituximab achieves 43% PFS risk reduction in frontline MCL

• US FDA approves Orca Bio’s TREGZI™, as first precision‑engineered cell therapy for matched‑donor stem cell transplant in adult hematological malignancies

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BRUKINSA + rituximab achieves 43% PFS risk reduction in frontline MCL (Ref)

BeOne Medicines announced that BRUKINSA (zanubrutinib; BTK inhibitor) combined with rituximab met the primary progression-free survival endpoint in the Phase 3 MANGROVE trial, demonstrating a 43% reduction in the risk of progression or death (HR=0.57; p<0.0001) vs bendamustine plus rituximab (BR) in adult patients with previously untreated mantle cell lymphoma (MCL)

• PFS showed highly significant improvement, assessed by independent review.

• Overall survival (OS) data are immature but trending positively for BRUKINSA + rituximab

• Safety profile consistent with known data; no new signals identified

Full results from MANGROVE, including efficacy and safety, will be presented at an upcoming medical meeting; global regulatory submissions are planned for 2H 2026

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US FDA approves Orca Bio’s TREGZI™, as first precision‑engineered cell therapy for matched‑donor stem cell transplant in adult hematological malignancies (Ref)

Orca Bio received US FDA approval for TREGZI™ (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq), clinically known as Orca-T®, a precision-engineered cell therapy for use in matched-donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (GVHD)-free survival (cGFS), in the treatment of adults with hematological malignancies.

This marks Orca Bio's first approved product, validating its high-precision cell therapy platform

The FDA approval is based on results from the randomized, multi-center, Phase 3 Precision-T study of patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL)

• TREGZI + single-agent tacrolimus (TAC) vs conventional allogeneic hematopoietic stem cell transplant (alloHSCT) + TAC/methotrexate (TAC/MTX) demonstrated following results at 12 months

  
  

  • The primary endpoint of chronic cGFS: 78% vs 38% (HR 0.26; p<0.00001), an improvement driven by a reduction in chronic GVHD and fewer patient deaths

  • The rate of chronic GVHD: 13% vs 44% (HR 0.19; p<0.00002).

    
    

  • Overall survival (OS): 94% vs 83%

    
    

  • GVHD-free and relapse-free survival (GRFS): 63% vs 31%

    
    

  • Non-relapse mortality (NRM): 3% vs 13%

    
    

  • Additional safety findings were consistent with previous studies

    
    

    • The cumulative incidence for Grade 3 or 4 acute GVHD at day +180: 6% vs 10% (HR 0.37; p=0.044)

      
      

    • Grade 3 infections were less common with TREGZI, with a one year estimated incidence of 44% for TREGZI and 51% for alloHSCT 

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