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Authors | X. Pivot, I.M. Bondarenko, Z. Nowecki, M. Dvorkin, E. Trishkina, J.H. Ahn, Y. Vinnyk, S-A. Im, T. Sarosiek, S. Chatterjee, M. Wojtukiewicz, V. Moiseyenko, Y. Shparyk, M. Bello III, V. Semiglazov, L. Younju, J. Lim | ||||||||||||
Title | One-year safety, immunogenicity, and survival results from a phase III study comparing SB3 (a proposed trastuzumab biosimilar) and originator trastuzumab in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment | ||||||||||||
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URL | https://www.annalsofoncology.org/article/S0923-7534(20)37516-5/fulltext | ||||||||||||
Abstract Text | Background: Equivalence for efficacy between SB3 (a proposed trastuzumab biosimilar) and originator trastuzumab (TRZ) in terms of breast pathologic complete response (bpCR) rates has been demonstrated and previously reported.1 Here we present the one-year results on safety, immunogenicity, event-free-survival (EFS), and overall survival (OS). Methods: Study compared neoadjuvant SB3 or TRZ for 8 cycles concurrently with chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil/epirubicin/cyclophosphamide). Patients then underwent surgery followed by 10 cycles of adjuvant SB3 or TRZ as randomised. The primary endpoint was bpCR rate and secondary endpoints included safety, immunogenicity, EFS, and OS up to the adjuvant period. Results: A total of 875 patients were randomised with a median follow-up duration of 438 days, and 765 patients completed adjuvant therapy (SB3, N = 381; TRZ, N = 384). Incidences of treatment emergent adverse events (TEAEs) were comparable between arms (Table). Most frequently occurring TEAEs were alopecia, neutropenia, and nausea during the neoadjuvant period and radiation skin injury, procedural pain, and fatigue during the adjuvant period. EFS rates were 92.2% in SB3 and 91.6% in TRZ (hazard ratio 0.94; 95% CI, 0.59 to 1.51). There were a total of 6 deaths (SB3, N = 1; TRZ, N = 5). Immunogenicity was low and comparable, with anti-drug antibody positive for 3 patients (0.7%), in each arm. |
Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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SB3 | HER2 (ERBB2) Antibody 72 | SB3 is a Herceptin (trastuzumab) biosimilar that binds to Erbb2 (Her2) and induces anti-tumor immune response against Erbb2 (Her2)-positive tumors (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 153PD). |
Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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