---
title: "Cusatuzumab plus venetoclax ± azacitidine in unfit newly diagnosed AML: Phase Ib ELEVATE study"
id: "pubmed-42689432"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42689432"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42689432/"
doi: "10.3324/haematol.2026.300917"
published_at: "2026-09-03T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Cusatuzumab plus venetoclax ± azacitidine in unfit newly diagnosed AML: Phase Ib ELEVATE study
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42689432
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42689432/)
- **DOI:** [10.3324/haematol.2026.300917](https://doi.org/10.3324%2Fhaematol.2026.300917)
- **Published At:** 2026-09-03T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This PubMed record reports the Phase Ib **ELEVATE** study evaluating **cusatuzumab** combined with **venetoclax**, with or without **azacitidine**, in patients deemed unfit for intensive therapy with newly diagnosed **acute myeloid leukemia (AML)**. - The manuscript is listed in Haematologica, published online ahead of print with DOI 10.3324/haematol.2026.300917 and PubMed ID 42689432. - The author list is extensive and multinational; lead author is Gail J Roboz, with contributors from academic centers and industry (including argenx, Janssen R&D, OncoVerity, RefinedScience). - Participating institutions include Weill Cornell Medicine, Bern University Hospital, City of Hope, University of Alberta, multiple European and North American cancer centers, and several industry collaborators. - The PubMed entry provides article metadata (title, authors, affiliations, journal, DOI, PMID, and date) but does not include the abstract text, study methods, patient numbers, efficacy endpoints, safety data, or outcomes in the accessible snippet. - No specific numerical results, response rates, survival outcomes, adverse events, dose levels, or statistical analyses are reported in the source content provided here. - Because the full abstract and manuscript content were not present in the supplied source text, details on design elements (randomization, cohort sizes, inclusion/exclusion criteria), treatment schedules, or conclusions are not reported and cannot be inferred. - The record notes the work is online ahead of print (2026 Sep 3). Contact information for the corresponding author and the DOI are provided for retrieval of the full report. - Users should consult the full journal article or PubMed abstract page for complete methods, results, safety, and authors’ interpretations; those elements are not included in the source text used for this rewrite.
## Clinical Analysis & Structured Key Points
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Online ahead of print. # Cusatuzumab combined with venetoclax with or without azacitidine in unfit patients with newly diagnosed acute myeloid leukemia: phase Ib ELEVATE study [Gail J Roboz](https://pubmed.ncbi.nlm.nih.gov/?term=Roboz+GJ&cauthor_id=42689432)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-1 "Weill Cornell Medicine and the New York Presbyterian Hospital, New York, NY. gar2001@cornell.edu."), [Thomas Pabst](https://pubmed.ncbi.nlm.nih.gov/?term=Pabst+T&cauthor_id=42689432)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-2 "Bern University Hospital, Bern."), [Ahmed Aribi](https://pubmed.ncbi.nlm.nih.gov/?term=Aribi+A&cauthor_id=42689432)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-3 "City of Hope Comprehensive Cancer Center, Duarte, CA."), [Joseph M Brandwein](https://pubmed.ncbi.nlm.nih.gov/?term=Brandwein+JM&cauthor_id=42689432)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-4 "University of Alberta, Edmonton, AB."), [Hartmut Döhner](https://pubmed.ncbi.nlm.nih.gov/?term=D%C3%B6hner+H&cauthor_id=42689432)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-5 "University Hospital of Ulm, Ulm."), [Walter Fiedler](https://pubmed.ncbi.nlm.nih.gov/?term=Fiedler+W&cauthor_id=42689432)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-6 "Hubertus Wald University Cancer Center, Hamburg-Eppendorf, Hamburg."), [Carsten Riether](https://pubmed.ncbi.nlm.nih.gov/?term=Riether+C&cauthor_id=42689432)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-2 "Bern University Hospital, Bern."), [Domenica Gandini](https://pubmed.ncbi.nlm.nih.gov/?term=Gandini+D&cauthor_id=42689432)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-7 "argenx, Ghent."), [Michelle Geddes](https://pubmed.ncbi.nlm.nih.gov/?term=Geddes+M&cauthor_id=42689432)[ 8 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-8 "Tom Baker Cancer Centre, Calgary, AB."), [Jing-Zhou Hou](https://pubmed.ncbi.nlm.nih.gov/?term=Hou+JZ&cauthor_id=42689432)[ 9 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-9 "University of Pittsburgh Hillman Cancer Centers, Pittsburgh, PA."), [Karen Yee](https://pubmed.ncbi.nlm.nih.gov/?term=Yee+K&cauthor_id=42689432)[ 10 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-10 "Princess Margaret Cancer Centre, Toronto, ON."), [Anna Hultberg](https://pubmed.ncbi.nlm.nih.gov/?term=Hultberg+A&cauthor_id=42689432)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-7 "argenx, Ghent."), [Eric Huselton](https://pubmed.ncbi.nlm.nih.gov/?term=Huselton+E&cauthor_id=42689432)[ 11 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-11 "University of Rochester, Rochester, NY."), [Julie Jacobs](https://pubmed.ncbi.nlm.nih.gov/?term=Jacobs+J&cauthor_id=42689432)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-7 "argenx, Ghent."), [Piotr Zabrocki](https://pubmed.ncbi.nlm.nih.gov/?term=Zabrocki+P&cauthor_id=42689432)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-7 "argenx, Ghent."), [Ewa Lech-Marańda](https://pubmed.ncbi.nlm.nih.gov/?term=Lech-Mara%C5%84da+E&cauthor_id=42689432)[ 12 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-12 "Instytut Hematologii i Transfuzjologii Indiry Gandhi 14, Warsaw."), [Marieke Louwers](https://pubmed.ncbi.nlm.nih.gov/?term=Louwers+M&cauthor_id=42689432)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-7 "argenx, Ghent."), [Kerri Nottage](https://pubmed.ncbi.nlm.nih.gov/?term=Nottage+K&cauthor_id=42689432)[ 13 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-13 "Janssen R&D, Raritan, NJ."), [Uwe Platzbecker](https://pubmed.ncbi.nlm.nih.gov/?term=Platzbecker+U&cauthor_id=42689432)[ 14 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-14 "Universitätsklinikum Leipzig, Leipzig."), [Raajit Rampal](https://pubmed.ncbi.nlm.nih.gov/?term=Rampal+R&cauthor_id=42689432)[ 15 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-15 "Memorial Sloan Kettering Cancer Center, New York, NY."), [Masha Salman](https://pubmed.ncbi.nlm.nih.gov/?term=Salman+M&cauthor_id=42689432)[ 13 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-13 "Janssen R&D, Raritan, NJ."), [Priya Shah](https://pubmed.ncbi.nlm.nih.gov/?term=Shah+P&cauthor_id=42689432)[ 16 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-16 "Janssen R&D, High Wycombe, Buckinghamshire."), [Kayla Wilson](https://pubmed.ncbi.nlm.nih.gov/?term=Wilson+K&cauthor_id=42689432)[ 17 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-17 "Norton Cancer Institute, Louisville, KY."), [Monic Stuart](https://pubmed.ncbi.nlm.nih.gov/?term=Stuart+M&cauthor_id=42689432)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-7 "argenx, Ghent."), [Marion Subklewe](https://pubmed.ncbi.nlm.nih.gov/?term=Subklewe+M&cauthor_id=42689432)[ 18 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-18 "Klinikum der Universität München, Munich."), [Anne Sumbul](https://pubmed.ncbi.nlm.nih.gov/?term=Sumbul+A&cauthor_id=42689432)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-7 "argenx, Ghent."), [Eunice S Wang](https://pubmed.ncbi.nlm.nih.gov/?term=Wang+ES&cauthor_id=42689432)[ 19 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-19 "Roswell Park Comprehensive Cancer Center, Buffalo, NY."), [Agnieszka Wierzbowska](https://pubmed.ncbi.nlm.nih.gov/?term=Wierzbowska+A&cauthor_id=42689432)[ 20 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-20 "Medical University of Lodz, Lodz, Poland; Provincial Multi-Specialized Oncology and Trauma Center, Lodz."), [Bin Yao](https://pubmed.ncbi.nlm.nih.gov/?term=Yao+B&cauthor_id=42689432)[ 21 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-21 "OncoVerity, Aurora, CO."), [Ravi Patel](https://pubmed.ncbi.nlm.nih.gov/?term=Patel+R&cauthor_id=42689432)[ 21 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-21 "OncoVerity, Aurora, CO."), [Adam George](https://pubmed.ncbi.nlm.nih.gov/?term=George+A&cauthor_id=42689432)[ 21 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-21 "OncoVerity, Aurora, CO."), [Nazmul Islam](https://pubmed.ncbi.nlm.nih.gov/?term=Islam+N&cauthor_id=42689432)[ 22 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-22 "RefinedScience, Aurora, CO."), [Clay Smith](https://pubmed.ncbi.nlm.nih.gov/?term=Smith+C&cauthor_id=42689432)[ 21 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-21 "OncoVerity, Aurora, CO."), [Michael Boyiadzis](https://pubmed.ncbi.nlm.nih.gov/?term=Boyiadzis+M&cauthor_id=42689432)[ 21 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-21 "OncoVerity, Aurora, CO."), [Gautam Borthakur](https://pubmed.ncbi.nlm.nih.gov/?term=Borthakur+G&cauthor_id=42689432)[ 23 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#full-view-affiliation-23 "University of Texas MD Anderson Cancer Center, Houston, TX.") Affiliations Expand ### Affiliations * 1 Weill Cornell Medicine and the New York Presbyterian Hospital, New York, NY. gar2001@cornell.edu. * 2 Bern University Hospital, Bern. * 3 City of Hope Comprehensive Cancer Center, Duarte, CA. * 4 University of Alberta, Edmonton, AB. * 5 University Hospital of Ulm, Ulm. * 6 Hubertus Wald University Cancer Center, Hamburg-Eppendorf, Hamburg. * 7 argenx, Ghent. * 8 Tom Baker Cancer Centre, Calgary, AB. * 9 University of Pittsburgh Hillman Cancer Centers, Pittsburgh, PA. * 10 Princess Margaret Cancer Centre, Toronto, ON. * 11 University of Rochester, Rochester, NY. * 12 Instytut Hematologii i Transfuzjologii Indiry Gandhi 14, Warsaw. * 13 Janssen R&D, Raritan, NJ. * 14 Universitätsklinikum Leipzig, Leipzig. * 15 Memorial Sloan Kettering Cancer Center, New York, NY. * 16 Janssen R&D, High Wycombe, Buckinghamshire. * 17 Norton Cancer Institute, Louisville, KY. * 18 Klinikum der Universität München, Munich. * 19 Roswell Park Comprehensive Cancer Center, Buffalo, NY. * 20 Medical University of Lodz, Lodz, Poland; Provincial Multi-Specialized Oncology and Trauma Center, Lodz. * 21 OncoVerity, Aurora, CO. * 22 RefinedScience, Aurora, CO. * 23 University of Texas MD Anderson Cancer Center, Houston, TX. * PMID: **42689432** * DOI: [ 10.3324/haematol.2026.300917 ](https://doi.org/10.3324/haematol.2026.300917) Item in Clipboard # Cusatuzumab combined with venetoclax with or without azacitidine in unfit patients with newly diagnosed acute myeloid leukemia: phase Ib ELEVATE study Gail J Roboz et al. Haematologica. 2026. Show details Display options Display options Format Abstract PubMed PMID Haematologica Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Haematologica%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Haematologica%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42689432/) . 2026 Sep 3. doi: 10.3324/haematol.2026.300917. Online ahead of print. ### Authors [Gail J Roboz](https://pubmed.ncbi.nlm.nih.gov/?term=Roboz+GJ&cauthor_id=42689432)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-1 "Weill Cornell Medicine and the New York Presbyterian Hospital, New York, NY. gar2001@cornell.edu."), [Thomas Pabst](https://pubmed.ncbi.nlm.nih.gov/?term=Pabst+T&cauthor_id=42689432)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-2 "Bern University Hospital, Bern."), [Ahmed Aribi](https://pubmed.ncbi.nlm.nih.gov/?term=Aribi+A&cauthor_id=42689432)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-3 "City of Hope Comprehensive Cancer Center, Duarte, CA."), [Joseph M Brandwein](https://pubmed.ncbi.nlm.nih.gov/?term=Brandwein+JM&cauthor_id=42689432)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-4 "University of Alberta, Edmonton, AB."), [Hartmut Döhner](https://pubmed.ncbi.nlm.nih.gov/?term=D%C3%B6hner+H&cauthor_id=42689432)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-5 "University Hospital of Ulm, Ulm."), [Walter Fiedler](https://pubmed.ncbi.nlm.nih.gov/?term=Fiedler+W&cauthor_id=42689432)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-6 "Hubertus Wald University Cancer Center, Hamburg-Eppendorf, Hamburg."), [Carsten Riether](https://pubmed.ncbi.nlm.nih.gov/?term=Riether+C&cauthor_id=42689432)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-2 "Bern University Hospital, Bern."), [Domenica Gandini](https://pubmed.ncbi.nlm.nih.gov/?term=Gandini+D&cauthor_id=42689432)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-7 "argenx, Ghent."), [Michelle Geddes](https://pubmed.ncbi.nlm.nih.gov/?term=Geddes+M&cauthor_id=42689432)[ 8 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-8 "Tom Baker Cancer Centre, Calgary, AB."), [Jing-Zhou Hou](https://pubmed.ncbi.nlm.nih.gov/?term=Hou+JZ&cauthor_id=42689432)[ 9 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-9 "University of Pittsburgh Hillman Cancer Centers, Pittsburgh, PA."), [Karen Yee](https://pubmed.ncbi.nlm.nih.gov/?term=Yee+K&cauthor_id=42689432)[ 10 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-10 "Princess Margaret Cancer Centre, Toronto, ON."), [Anna Hultberg](https://pubmed.ncbi.nlm.nih.gov/?term=Hultberg+A&cauthor_id=42689432)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-7 "argenx, Ghent."), [Eric Huselton](https://pubmed.ncbi.nlm.nih.gov/?term=Huselton+E&cauthor_id=42689432)[ 11 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-11 "University of Rochester, Rochester, NY."), [Julie Jacobs](https://pubmed.ncbi.nlm.nih.gov/?term=Jacobs+J&cauthor_id=42689432)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-7 "argenx, Ghent."), [Piotr Zabrocki](https://pubmed.ncbi.nlm.nih.gov/?term=Zabrocki+P&cauthor_id=42689432)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-7 "argenx, Ghent."), [Ewa Lech-Marańda](https://pubmed.ncbi.nlm.nih.gov/?term=Lech-Mara%C5%84da+E&cauthor_id=42689432)[ 12 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-12 "Instytut Hematologii i Transfuzjologii Indiry Gandhi 14, Warsaw."), [Marieke Louwers](https://pubmed.ncbi.nlm.nih.gov/?term=Louwers+M&cauthor_id=42689432)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-7 "argenx, Ghent."), [Kerri Nottage](https://pubmed.ncbi.nlm.nih.gov/?term=Nottage+K&cauthor_id=42689432)[ 13 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-13 "Janssen R&D, Raritan, NJ."), [Uwe Platzbecker](https://pubmed.ncbi.nlm.nih.gov/?term=Platzbecker+U&cauthor_id=42689432)[ 14 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-14 "Universitätsklinikum Leipzig, Leipzig."), [Raajit Rampal](https://pubmed.ncbi.nlm.nih.gov/?term=Rampal+R&cauthor_id=42689432)[ 15 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-15 "Memorial Sloan Kettering Cancer Center, New York, NY."), [Masha Salman](https://pubmed.ncbi.nlm.nih.gov/?term=Salman+M&cauthor_id=42689432)[ 13 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-13 "Janssen R&D, Raritan, NJ."), [Priya Shah](https://pubmed.ncbi.nlm.nih.gov/?term=Shah+P&cauthor_id=42689432)[ 16 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-16 "Janssen R&D, High Wycombe, Buckinghamshire."), [Kayla Wilson](https://pubmed.ncbi.nlm.nih.gov/?term=Wilson+K&cauthor_id=42689432)[ 17 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-17 "Norton Cancer Institute, Louisville, KY."), [Monic Stuart](https://pubmed.ncbi.nlm.nih.gov/?term=Stuart+M&cauthor_id=42689432)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-7 "argenx, Ghent."), [Marion Subklewe](https://pubmed.ncbi.nlm.nih.gov/?term=Subklewe+M&cauthor_id=42689432)[ 18 ](https://pubmed.ncbi.nlm.nih.gov/42689432/#short-view-affiliation-18 "Klinikum der Universität München, Munich."), [Anne Sumbul](https://pubmed.ncbi.nlm.nih.gov/?term=Sumbul+A&cautho
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