Clinical experience with CD64-directed immunotherapy. An overview
Open accessAbstract
The class I IgG receptor (Fc gamma RI or CD64 receptor), which is present on key cytotoxic effector cells, has been shown to initiate the destruction of tumor cells in vitro and has been hypothesized to play a role in the destruction of antibody-coated cells such as platelets in idiopathic thrombocytopenia purpura (ITP). This overview summarizes the clinical experience with CD64-directed immunotherapy in cancer patients with the bispecific antibodies MDX-447 [humanized Fab anti-CD64 x humanized Fab anti-(epidermal growth factor receptor, EGFR)] and MDX-H210 (humanized Fab anti-DC64 x Fab anti-HER2/neu), and with the anti-CD64 monoclonal antibody (mAB) MDX-33 (H22) in the modulation of monocyte CD64 in vivo. In an ongoing phase I/II open-label trial with progressive dose escalation (1-15 mg/m2), patients with treatment refractory EGFR-positive cancers (renal cell carcinoma (RCC), head and neck, bladder, ovarian, prostate cancer and skin cancer) are treated weekly with intravenous MDX-447, with and without granulocyte-colony-stimulating factor (G-CSF). MDX-447 has been found to be immunologically active at all doses, binding to circulating monocytes and neutrophils (when given with G-CSF), causing monocytopenia and stimulating increases in circulating plasma cytokines. MDX-447 is well tolerated, the primary toxicities being fever, chills, blood pressure lability, and pain/ myalgias. Of 36 patients evaluable for response, 9 have experienced stable disease of 3-6 month's duration. The optimal dose and the maximal tolerated dose (MTD) have yet to be defined; dose escalation continues to define better the dose, toxicity, and the potential therapeutic role of this bispecific antibody. Three MDX-H210 phase II trials are currently in progress, all using the intravenous dose of 15 mg/m2 given with granulocyte/macrophage (GM-CSF). These consist of one trial each in the treatment of RCC patients, patients with prostate cancer, and colorectal cancer patients, all of whom have failed standard therapy. At the time of writing, 11 patients have been treated in these phase II trials. Four patients have demonstrated antitumor effects. Patients demonstrating responses include 2 with RCC and 2 with prostate cancer. One RCC patient has had a 54% reduction in size of a hepatic metastatic lesion and the other has had a 49% decrease in the size of a lung metastasis with simultaneous clearing of other non-measurable lung lesions. Regarding the two patients with prostate cancer, one has had a 90% reduction in serum prostate-specific antigen (PSA; 118-11 ng/ml), which has persisted for several months; the other patient with prostate has had a 70% reduction of serum PSA (872 ng/ml to 208 ng/ml) within the first month of treatment. Both patients have also demonstrated symptomatic improvement. In a completed phase I and in ongoing phase I/II clinical trials, patients with treatment-refractory HER2/neu positive cancers (breast, ovarian, colorectal, prostate) have been treated with MDX-H210, which has been given alone and in conjunction with G-CSF, GM-CSF, and interferon gamma (IFN gamma). These trials have been open-label, progressive dose-escalation (0.35-135 mg/m2) studies in which single, and more often, multiple weekly doses have been administered. MDX-H210 has been well tolerated, with untoward effects being primarily mild-to-moderate flu-like symptoms. The MTD has not yet been defined. MDX-H210 is immunologically active, binding to circulating monocytes, causing monocytopenia, as well as stimulating increases in plasma cytokine levels. Furthermore, some patients have evidence of active antitumor immunity following treatment with MDX-210. Antitumor effects have been seen in response to MDX-H210 administration; these include 1 partial, 2 minor, and 1 mixed tumor response; 15 protocol-defined stable disease responses have occurred. (ABSTRACT TRUNCATED)
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Chemically linked bispecific (Fab')2 molecules targeting HER2 or EGFR were tested in clinical trials; these antigens are overexpressed in many epithelial tumors such as colorectal, head and neck, bladder, renal, and non-small cell lung carcinoma.
“A series of clinical trials were also performed with chemically linked bispecific (Fab')2 molecules targeting the breast and ovarian cancer tumor antigens HER2 or EGFR, [9][10][11][12] which are overexpressed in many epithelial tumors such as colorectal, head and neck, bladder, renal, non-small cell lung carcinoma.”
From Bispecific antibodies for cancer therapy: The light at the end of the tunnel? (2009) · cites this paper as [11]
Biological effects were seen in some clinical trials of MDX-210, MDX-H210 and MDX-447, but none of these treatments led to consistent antitumor activity.
“Biological effects were seen in some clinical trials of bsAbs MDX-210 (targeting Her2 and CD64), MDX-H210 (humanized version of MDX-210) and MDX-447 (targeting EGFR and CD64), but none of these treatments led to consistent antitumor activity. [9][10]0][11][12]”
From Bispecific antibodies for cancer therapy: The light at the end of the tunnel? (2009) · cites this paper as [11]
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- Authors
- Curnow, R. T.
- Corresponding author
- Curnow, Randall T.
- Venue
- Cancer Immunology, Immunotherapy
- Published
- 1997-11-24
- Volume
- 45
- Issue
- 3-4
- Pages
- 210-215
- ISSN
- 0340-7004 (ISSN-L)
- 1432-0851
- PMC
- PMC11037766
- OpenAlex
- W2051699257
- Cited by
- 141
- References
- 3
- Citations by year
- 2024: 2 · 2023: 4 · 2022: 3 · 2021: 4 · 2020: 4 · 2018: 3 · 2017: 2 · 2016: 1 · 2015: 1 · 2014: 6 · 2013: 4 · 2012: 2
- FWCI
- 8.01
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Cancer Immunology Immunotherapy (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Keywords
- CD64, FcγRI, bispecific antibodies, HER2/neu, renal cell carcinoma, prostate cancer, granulocyte colony-stimulating factor, GM-CSF, dose escalation, monocytopenia
- MeSH terms
- Humans, Neoplasms, Purpura, Thrombocytopenic, Idiopathic, Clinical Trials, Phase I as Topic, Clinical Trials, Phase II as Topic, Receptors, IgG, Antibodies, Bispecific, Erb-b2 Receptor Tyrosine Kinases, Receptor, ErbB-2, ErbB Receptors
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