A pilot, phase Ib feasibility study of ARGX-110 in patients with nasopharyngeal carcinoma (NPC)
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1
Ghent University Hospital, Department of Pharmacology (1) + Drug Research Unit Ghent (2), Belgium
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2
Ghent University Hospital, Department of Medical Oncology, Belgium
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3
Ghent University Hospital, Department of Head and Neck and Maxillofacial Surgery, Belgium
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4
Ghent University Hospital, Department of Medical and Forensic Pathology, Belgium
Background: ARGX-110 is a monoclonal antibody targeting CD70. A phase Ib study is running at the Ghent University Hospital
to determine the safety profile of ARGX-110 administered as mono- or combination therapy to patients with nasopharyngeal
carcinoma (NPC) at various stages of disease.
Patients and methods: ARGX-110 was administered at a dose of 5mg/kg, IV, every three weeks in patients with histologically
proven NPC. Patients were ≥ 18 years, had an ECOG performance status ≤ 2 and adequate bone marrow, liver and renal function.
Exclusion criteria consisted of central nervous system involvement, major surgery within 4 weeks of first administration,
unresolved grade 3 or 4 toxicity from prior therapy, active infection, childbearing potential/pregnancy/lactation, hypersensitivity
to recombinant proteins and psychiatric/ behavioral problems. Safety assessment included close monitoring of adverse events
(AEs), registration of demographics, medical history, biochemistry and hematology.
Results: Eleven patients (nine male, two female) with a median age of 47 years (range 23-76) were enrolled since February
2015. All patients were diagnosed with stage III (n=2) or stage IV (n=9) NPC. So far, the median number of cycles administered
was three (range 1 to 18) and administration was well tolerated. One patient was hospitalized because of infection for which
treatment was delayed for three weeks. Two other patients developed an infusion reaction (grade 1-2).
Conclusions: The ongoing study shows that administration of ARGX-110, 5mg/kg IV every three weeks, is feasible in patients
with NPC. Survival data will be reported after completion of the trial. The exploration of predictive biomarkers is ongoing.
Keywords:
CD70,
NPC,
immunotherapy and NPC
Conference:
EUFEMED 2017, London, United Kingdom, 17 May - 19 May, 2017.
Presentation Type:
Oral and Poster
Topic:
EUFEMED 2017 CONFERENCE
Citation:
Rottey
S,
De Meulenaere
A,
Deron
P and
Ferdinande
L
(2019). A pilot, phase Ib feasibility study of ARGX-110 in patients with nasopharyngeal carcinoma (NPC).
Front. Pharmacol.
Conference Abstract:
EUFEMED 2017.
doi: 10.3389/conf.fphar.2017.62.00003
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Received:
29 Aug 2017;
Published Online:
25 Jan 2019.
*
Correspondence:
Dr. Sylvie Rottey, Ghent University Hospital, Department of Pharmacology (1) + Drug Research Unit Ghent (2), Ghent, Belgium, sylvie.rottey@uzgent.be