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Final analysis of phase II study of EZN-2208 (PEG-SN38) in metastatic breast cancer (MBC).
Abstract
1017 Background: EZN-2208 is a water-soluble PEGylated conjugate of SN38. EZN-2208 results in prolonged exposure of tumors to SN38 via preferential accumulation of EZN-2208 in the tumor and prolonged release of SN38. These data represent the final analysis of our study evaluating EZN-2208 in MBC. Methods: EZN-2208 9 mg/m2 (SN38 equivalents) was delivered as a 60-minute IV infusion, weekly for 3 wks in 4‑wk cycles. The primary objective was to determine the overall response rate (RR) in female patients with metastatic breast cancer (MBC) who had received prior adjuvant or metastatic therapy with either 1) anthracycline and taxane (AT) or 2) anthracycline, taxane, and capecitabine (ATX). Secondary objectives included evaluation of RR based on tumor receptor status, duration of response, progression-free survival (PFS), overall survival (OS), and safety. Results: Patients with MBC (n=164) were treated with a median (range) of 3.3 (0.3-22) cycles of EZN-2208. The objective response rate (RR) was 20% for AT and 9% for ATX. The clinical benefit rate (CBR=%CR + %PR + %SD ≥6 months) was 41% and 27% in patients in the AT and ATX cohorts, respectively. The RR and CBR among ER+ patients were 11% (10/91 pts) and 41.8% (38/91 pts). In patients who progressed during or within 30 days of prior platinum-containing regimens (Platinum Progressors), the CBR was 20% (8/40 pts). Among triple negative breast cancer (TNBC) patients, the RR and CBR were 22.5% (11/49 pts) and 36.7% (18/49 pts). For T…
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In patients with metastatic triple-negative breast cancer, EZN-2208 produced objective response and clinical benefit rates of 22.5% and 36.7%, respectively.
“In patients with metastatic triple-negative breast cancer, objective response and clinical benefit rates of 22.5% and 36.7%, respectively, were reported [328].”
From HIF inhibition: Current strategies and clinical challenges (2026) · cites this paper as [328]
EZN-2208 was generally well tolerated across multiple early-phase clinical studies in solid malignancies.
“Across these studies, EZN-2208 was generally well tolerated.”
From HIF inhibition: Current strategies and clinical challenges (2026) · cites this paper as [328]
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Cited by 10
Metadata
- Authors
- Osborne, C. R. C., O'Shaughnessy, J., Holmes, F. A., Kim, H. S., Kocs, D. M., Steinberg, M. S., Richards, P. D., Vukelja, S. J., Berkowitz, N. C., & Buchbinder, A.
- Affiliations
- Baylor Sammons Cancer Center, Texas Oncology PA, US Oncology, Dallas, TX
- Baylor Sammons Cancer Center and Texas Oncology, US Oncology, Dallas, TX
- Texas Oncology, US Oncology, Houston, TX
- Rocky Mountain Cancer Centers (US)
- US Oncology Research, LLC, McKesson Specialty Health, The Woodlands, TX, and Texas Oncology - Austin Central, Austin, TX
- Virginia Oncology Associates (US)
- Salem VA Medical Center (US)
- US Oncology Research, The Woodlands, TX; Texas Oncology, Tyler, TX
- Enzon Pharmaceuticals (United States) (US)
- Venue
- Journal of Clinical Oncology
- Published
- 2012-05-20
- Volume
- 30
- Issue
- 15_suppl
- Pages
- 1017-1017
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2598178845
- Cited by
- 10
- References
- 0
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2022: 1 · 2021: 1 · 2019: 1 · 2013: 1 · 2012: 3
- Type
- conference abstract
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Cancer therapeutics and mechanisms
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Keywords
- SN-38, metastatic breast cancer, capecitabine, triple-negative breast cancer, estrogen receptor-positive breast cancer, platinum-resistant disease, objective response rate, progression-free survival, overall survival, drug safety, neutropenia, diarrhea
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