The B7-H3–Targeting Antibody–Drug Conjugate m276-SL-PBD Is Potently Effective Against Pediatric Cancer Preclinical Solid Tumor Models
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Abstract
Purpose: Patients with relapsed pediatric solid malignancies have few therapeutic options, and many of these patients die of their disease. B7-H3 is an immune checkpoint protein encoded by the CD276 gene that is overexpressed in many pediatric cancers. Here, we investigate the activity of the B7-H3–targeting antibody–drug conjugate (ADC) m276-SL-PBD in pediatric solid malignancy patient-derived (PDX) and cell line–derived xenograft (CDX) models. Experimental Design: B7-H3 expression was quantified by RNA sequencing and by IHC on pediatric PDX microarrays. We tested the safety and efficacy of m276-SL-PBD in two stages. Randomized trials of m276-SL-PBD of 0.5 mg/kg on days 1, 8, and 15 compared with vehicle were performed in PDX or CDX models of Ewing sarcoma (N = 3), rhabdomyosarcoma (N = 4), Wilms tumors (N = 2), osteosarcoma (N = 5), and neuroblastoma (N = 12). We then performed a single mouse trial in 47 PDX or CDX models using a single 0.5 m/kg dose of m276-SL-PBD. Results: The vast majority of PDX and CDX samples studied showed intense membranous B7-H3 expression (median H-score 177, SD 52). In the randomized trials, m276-SL-PBD showed a 92.3% response rate, with 61.5% of models showing a maintained complete response (MCR). These data were confirmed in the single mouse trial with an overall response rate of 91.5% and MCR rate of 64.4%. Treatment-related mortality rate was 5.5% with late weight loss observed in a subset of models dosed once a week for 3 weeks. Conclusions: m276-SL-PBD has significant antitumor activity across a broad panel of pediatric solid tumor PDX models.
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Preclinical data evaluating antibody-drug conjugates targeting B7H3, LRRC15 and HER2 in osteosarcoma have been particularly promising and are rapidly moving to and through clinical trials.
“Preclinical data evaluating antibody-drug conjugates, such as those targeting B7H3 (ref.90 ), LRRC15 (ref.86 ) and HER2 (ref.91 ), have been particularly promising and are rapidly moving to and through clinical trials.”
From Osteosarcoma (2022) · cites this paper as [90]
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- Authors
- Kendsersky, N. M., Lindsay, J., Kolb, E. A., Smith, M. A., Teicher, B. A., Erickson, S. W., Earley, E. J., Mosse, Y. P., Martinez, D., Pogoriler, J., Krytska, K., Patel, K., Groff, D., Tsang, M., Ghilu, S., Wang, Y., Seaman, S., Feng, Y., Croix, B. S., Gorlick, R., Kurmasheva, R., Houghton, P. J., & Maris, J. M.
- Affiliations
- Children's Hospital of Philadelphia (US)
- Alfred I. duPont Hospital for Children (US)
- National Cancer Institute (US)
- RTI International (US)
- 1Division of Oncology and Center for Childhood Cancer Research, Children's Hospital of Philadelphia, Pennsylvania.
- 6Division of Anatomic Pathology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
- The University of Texas at San Antonio Health Science Center (US)
- The University of Texas MD Anderson Cancer Center (US)
- Corresponding author
- Houghton, Peter J.
- Maris, John M.
- ORCID
- Kendsersky, Nathan M.
- Lindsay, Jarrett
- Kolb, E. Anders
- Smith, Malcolm A.
- Teicher, Beverly A.
- Erickson, Stephen W.
- Earley, Eric J.
- Mosse, Yael P.
- Pogoriler, Jennifer
- Krytska, Kateryna
- Patel, Khushbu
- Groff, David
- Tsang, Matthew
- Wang, Yifei
- Seaman, Steven
- Croix, Brad St.
- Gorlick, Richard
- Kurmasheva, Raushan
- Houghton, Peter J.
- Maris, John M.
- Venue
- Clinical Cancer Research
- Published
- 2021-02-22
- Volume
- 27
- Issue
- 10
- Pages
- 2938-2946
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- PMC
- PMC8127361
- OpenAlex
- W3129393016
- Cited by
- 120
- References
- 49
- Citations by year
- 2026: 15 · 2025: 27 · 2024: 18 · 2023: 22 · 2022: 19 · 2021: 19
- FWCI
- 7.10
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- other-oa
- Locations
- Clinical Cancer Research (publishedVersion, other-oa)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- NCI (U01 CA199287, R35 CA220500, U01 CA199221, NCI U01 CA199297, F31CA239424)
- Giulio D'Angio Endowed Chair
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Sarcoma Diagnosis and Treatment
- Keywords
- B7-H3, antibody-drug conjugates, pediatric solid tumors, Ewing sarcoma, rhabdomyosarcoma, Wilms tumor, osteosarcoma, neuroblastoma, patient-derived xenografts, cell line-derived xenografts, immune checkpoint, anticancer activity, non-relapse mortality
- MeSH terms
- Animals, Child, Disease Models, Animal, Female, Humans, Neoplasms, Pediatrics, Treatment Outcome, Immunoconjugates, Xenograft Model Antitumor Assays, Cell Line, Tumor, Mice, B7 Antigens
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