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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

3601 - Safety and clinical activity of MEDI0562, a humanized OX40 agonist monoclonal antibody, in adult patients with advanced solid tumors


20 Oct 2018


Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research


Clinical Research

Tumour Site


Bonnie Glisson


Annals of Oncology (2018) 29 (suppl_8): viii400-viii441. 10.1093/annonc/mdy288


B. Glisson1, R. Leidner2, R.L. Ferris3, J. Powderly4, N.A. Rizvi5, B. Keam6, R. Schneider7, S. Goel8, J.P. Ohr9, Y. Zheng10, S. Eck11, M. Gribbin12, D.M. Townsley13, V. Chiou13, S.P. Patel14

Author affiliations

  • 1 Thoracic Head And Neck Medical Oncology, MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 2 Medical Oncology, Providence Cancer Center Oncology and Hematology Care Clinic Eastside Portland, 97213 - Portland/US
  • 3 Immunology, University of Pittsburgh Cancer Center, 15232 - Pittsburgh/US
  • 4 Private Practice, Carolina BioOncology Institute, 28078 - Huntersville/US
  • 5 Hematology/oncology, Columbia University Medical Center, 10032 - New York/US
  • 6 Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR
  • 7 Oncology, Mary Crowley Cancer Research - Medical City, 75230 - Dallas/US
  • 8 Medical Oncology, Montefiore Medical Center(East campus) - Medical Park at Eastchester Albert Einstein Cancer Center, 10461 - Bronx/US
  • 9 Medical Oncology/hematology, UPMC Hillman Cancer Center, 15232 - Pittsburgh/US
  • 10 Clinical Pharmacology And Dmpk, MedImmune, 20878 - Gaithersburg/US
  • 11 Translational Sciences, MedImmune, 20878 - Gaithersburg/US
  • 12 Oncology, MedImmune, 28078 - Gaithersburg/US
  • 13 Oncology, MedImmune, 20878 - Gaithersburg/US
  • 14 Hematology/oncology, UC San Diego Moores Cancer Center, 92093 - La Jolla/US


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Abstract 3601


MEDI0562, a humanized IgG4 OX40 monoclonal antibody, demonstrated a manageable safety profile and pharmacologic activity in preliminary analyses of the Phase 1 study (NCT02318394) in pts with advanced solid tumors.1 Here we present updated safety data and clinical activity for pts treated during the dose-escalation phase.


Pts were treated with one of 6 escalating doses of MEDI0562 (0.03, 0.1, 0.3, 1.0, 3.0, and 10 mg/kg) every 2 weeks (Q2W) until confirmed disease progression or unacceptable toxicity. Tumor assessments were performed every 8 weeks with immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).


A total of 55 pts received MEDI0562 across 6 dose cohorts (3 + 3 design), with a maximum administered dose of 10 mg/kg Q2W and no DLTs observed. Median duration of exposure was 10 (2 to 48) weeks. Adverse events (AEs) and treatment-related AEs (trAEs) were reported in 96% and 67% of pts, respectively; the most common trAEs were fatigue (31%) and infusion-related reaction (15%). Gr 3 trAEs occurred in 16% of pts with the most common being pyrexia (4%); 53% of pts had trAEs of Gr1 or 2, with no apparent dose relation. There were no trAEs leading to discontinuation or Gr 4 or 5 trAEs. Of 50 response evaluable pts, 2 pts (sq cell carcinoma of the larynx – 0.03 mg/kg Q2W and bladder cancer – 3 mg/kg Q2W) had irPR at the first tumor assessment, with an overall survival of 13.8 and 10.2+ mos, respectively. Stable disease was seen in 22 (44%) pts with SD in 20 pts lasting >3 mos. Serum exposure of MEDI0562 increased approximately dose proportionally. Posttreatment antidrug antibody (ADA) was detected in 26 (51%) of 55 pts. ADA exhibited variable impact on PK exposure at all doses below 3 mg/kg. A 1.5 to 3.0-fold increase in mean peaks of the percentage of peripheral Ki67+ CD4+ and Ki67+ CD8 +memory T cells was observed across ascending dose levels.


MEDI0562 was generally well tolerated in adult pts with advanced solid tumors and exhibited clinical and pharmacological activity. Based on the ADA data, a suggested MEDI0562 Phase 2 dose of ≥ 3 mg/kg Q2W was selected. 1. Glisson et al Ann Oncol ESMO 2016.

Clinical trial identification


Legal entity responsible for the study



MedImmune, the global biologics R&D arm of AstraZeneca.

Editorial Acknowledgement


B. Glisson: Research funding to institution: Pfizer, Inc. R. Leidner: Institutional research funding: MedImmune, BMS, and Ignyta; Honoraria: AstraZeneca; Advisory board: Regeneron and Merck. R.L. Ferris: Advisory board: Amgen, AstraZeneca/MedImmune, Bristol-Myers Squibb, EMD Serono, PPD, Lilly, Merck, Pfizer, Tesaro; Clinical trial research funding: AstraZeneca/MedImmune, Bristol-Myers Squibb, Merck; Research funding: Tesaro, VentiRx Pharmaceuticals. J. Powderly: Clinical trial funding: AstraZeneca, Curis, Corvus, InCyte, AbbVie, BMS, MacroGenics, Top Alliance BioSciences. N.A. Rizvi: Consulting/Advisory board: AstraZeneca, Abbvie, BMS, Eli Lilly, Merck, Merck KGaA, Novartis, Pfizer, Regeneron, Roche; Board of directors member and shareholder: ARMO BioSciences; Co-founder and shareholder: Gritstone Oncology; Scientific advisory board member: Neogenomics. Y. Zheng, S. Eck, D.M. Townsley: Employee: MedImmune, AstraZeneca. S.P. Patel: Consulting, institutional research support: AstraZeneca/MedImmune. All other authors have declared no conflicts of interest.

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