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        <datestamp>2026-09-29T07:08:39Z</datestamp>
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          <dc:title>Cost-effectiveness of Orca-T vs allo-HCT with conventional GVHD prophylaxis for the treatment of advanced hematologic malignancies in the United States</dc:title>
          <dc:creator>Rawan Faramand (15021294)</dc:creator>
          <dc:creator>James Scott McClellan (25135854)</dc:creator>
          <dc:creator>Anna Pavlova (2610877)</dc:creator>
          <dc:creator>Rocio Manghani (17632727)</dc:creator>
          <dc:creator>Andrea Blank (25135857)</dc:creator>
          <dc:creator>Matia Saeedian (22698907)</dc:creator>
          <dc:creator>Shivani Yadav (12159236)</dc:creator>
          <dc:creator>Miguel-Angel Perales (496837)</dc:creator>
          <dc:subject>Medicine</dc:subject>
          <dc:subject>Cell Biology</dc:subject>
          <dc:subject>Ecology</dc:subject>
          <dc:subject>Biological Sciences not elsewhere classified</dc:subject>
          <dc:subject>Cancer</dc:subject>
          <dc:subject>Science Policy</dc:subject>
          <dc:subject>Hematology</dc:subject>
          <dc:subject>Cost-effectiveness</dc:subject>
          <dc:subject>allogeneic hematopoietic cell transplantation</dc:subject>
          <dc:subject>graft-versus-host disease</dc:subject>
          <dc:subject>post-transplant cyclophosphamide</dc:subject>
          <dc:subject>hematological malignancies</dc:subject>
          <dc:subject>United States</dc:subject>
          <dc:subject>mixture cure model</dc:subject>
          <dc:subject>I11</dc:subject>
          <dc:subject>D61</dc:subject>
          <dc:subject>I18</dc:subject>
          <dc:description>&lt;p&gt;Allogeneic hematopoietic cell transplantation (allo-HCT) is a potentially curative therapy for patients with hematologic malignancies, but its success is limited by graft‑versus‑host disease (GVHD), which carries considerable clinical and economic burden. A cost-effectiveness model was developed to evaluate whether the higher upfront costs of allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq (Tregzi [Orca-T; Orca Bio, Menlo Park, CA, USA]) are offset by reductions in GVHD and associated healthcare costs compared with conventional allo-HCT using TAC/MTX or PTCy.&lt;/p&gt; &lt;p&gt;A three-state partitioned survival model (relapse-free, relapsed, and dead) with a lifetime horizon and monthly cycles was developed. Overall survival and relapse-free survival data from the Phase 3 Precision-T study (ClinicalTrials.gov Identifier NCT05316701) were incorporated using a cure-mixture modeling approach to estimate long-term survival, relapse status, and cure fraction for patients. Costs included transplant procedure, GVHD management, infection management, and terminal care. Outcomes included life-years, quality-adjusted life-years (QALYs), and direct healthcare costs. Both costs and outcomes were discounted at 3% annually. A scenario analysis was conducted to determine the cost-effectiveness of Orca-T vs allo-HCT with PTCy for GVHD prophylaxis, and sensitivity analyses were conducted to test the uncertainty of the model inputs.&lt;/p&gt; &lt;p&gt;Orca‑T was associated with lower lifetime costs ($1,026,856 vs $2,170,875) and higher QALYs (15.28 vs 13.00) than conventional allo‑HCT with TAC/MTX, yielding cost savings of $1,144,019 and a gain of 2.28 QALYs per patient. GVHD-related costs were substantially lower with Orca‑T ($495,447 vs $1,998,621). Compared with PTCy, Orca‑T remained dominant, with cost savings of $158,144, a gain of 2.85 QALYs, and lower GVHD-related costs ($476,448 vs $999,945).&lt;/p&gt; &lt;p&gt;Orca‑T reduced costs and increased QALYs versus conventional allo‑HCT with TAC/MTX or PTCy, driven by lower GVHD and infection burden. These findings support Orca‑T as a high‑value treatment option.&lt;/p&gt;</dc:description>
          <dc:date>2026-09-29T07:08:39Z</dc:date>
          <dc:type>Text</dc:type>
          <dc:type>Journal contribution</dc:type>
          <dc:identifier>10.6084/m9.figshare.34021779.v1</dc:identifier>
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          <dc:rights>CC BY 4.0</dc:rights>
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