Currently Viewing:
Evidence-Based Oncology July 2017
Daratumumab With Standard Regimen Improves PFS, ORR Independent of Cytogenetic Risk in Multiple Myeloma
Surabhi Dangi-Garimella, PhD
Phase 1 Study Results at ASCO Support First-Line Use of Daratumumab in Multiple Myeloma
Surabhi Dangi-Garimella, PhD
Daratumumab-Based Combination Effective in Relapsed/Refractory Multiple Myeloma, Short PFS in Heavily Pretreated Patients
Surabhi Dangi-Garimella, PhD
Patient Selection Vital in Ensuring Improved Response to PD-1, PD-L1 Inhibitors in NSCLC
Surabhi Dangi-Garimella, PhD
An Early Stage Safety, Efficacy Study for Atezolizumab Plus Daratumumab in Advanced NSCLC
Surabhi Dangi-Garimella, PhD
LDH Levels Could Predict irAEs Associated With Checkpoint Inhibition and Radiotherapy in Lung Cancer
Surabhi Dangi-Garimella, PhD
Alectinib May Be a New Standard of Care for Treatment-Naïve ALK-Positive NSCLC
AJMC Staff
Dacomitinib a New First-Line Option for Advanced EGFR MutationŚPositive NSCLC
AJMC Staff
Androgen Deprivation, With or Without Radiotherapy, New Standard of Care in High-Risk Prostate Cancer
AJMC Staff
Trabectedin and Lurbinectedin Effective in BRCA2-Associated Metastatic Breast Cancer
AJMC Staff
HPV Vaccination May Lower Prevalence of Oropharyngeal Cancers in Young Adults
Surabhi Dangi-Garimella, PhD
Physical Activity, Healthy Diet Improve Survival in Colorectal Cancer: Study at ASCO
Surabhi Dangi-Garimella, PhD
Three Months of Oxaliplatin-Based Adjuvant Therapy Noninferior to 6 Months in Stage III Colon Cancer
AJMC Staff
Fas Biomarker Can Predict Response to Second-Line Therapy for Advanced Soft Tissue Sarcoma
AJMC Staff
Nivolumab, Alone or With Ipilimumab, Met the Disease Control Rate in Malignant Pleural Mesothelioma
AJMC Staff
Ibrutinib vs No Consolidation Are Being Compared Following Autologous HSCT in IRONCLAD Trial
AJMC Staff
Web-Based Patient Reporting of Symptoms Shown to Improve Survival in Patients With Metastatic Solid Tumors
AJMC Staff
Physician, Regulatory, and Payer Perspectives on the Value of Real-World Data
Surabhi Dangi-Garimella, PhD
Do We Have Adequate Surveillance in Cancer Care?
Surabhi Dangi-Garimella, PhD
MACRA 2.0 and Beyond: Preparing Your Practice to Meet the Quality and Reporting Challenges
Surabhi Dangi-Garimella, PhD
ASCO Study Finds Shift in Diagnosis Stage for Several Cancers Following ACA Implementation
Surabhi Dangi-Garimella, PhD
Switching Study Reports Equivalence Between Filgrastim, Biosimilar in Breast Cancer
Surabhi Dangi-Garimella, PhD
Currently Reading
Research Demonstrates Efficacy and Safety of Trastuzumab Biosimilar SB3
Kelly Davio
Can the 4 Ps Devise Interventions to Reduce the Financial Toxicity of Cancer?
Surabhi Dangi-Garimella, PhD
Adjuvant Chemotherapy Reduces Cost, Improves Survival in NSCLC Post-Surgery
Surabhi Dangi-Garimella, PhD
Brazilian Study Queries: Is NGS Cost-Effective in Advanced Lung Cancer?
Surabhi Dangi-Garimella, PhD
SEER-Medicare Database Analysis Notes Higher Resource Utilization Among Patients With Neuroendocrine Tumors
Surabhi Dangi-Garimella, PhD

Research Demonstrates Efficacy and Safety of Trastuzumab Biosimilar SB3

Kelly Davio
Research presented at the 2017 American Society of Clinical Oncology Annual Meeting showed that SB3, a proposed biosimilar to trastuzumab, has comparable efficacy, safety, immunogenicity, and pharmacokinetics to the reference product based on the breast pathological complete response.
A STUDY PRESENTED AT the 2017 American Society of Clinical Oncology Annual Meeting demonstrated that SB3, a proposed biosimilar to trastuzumab (TRZ), has comparable efficacy, safety, immunogenicity, and pharmacokinetics (PKs) to the reference product based on the breast pathological complete response (bpCR). The researchers defined the bpCR rate as the primary endpoint of the study, which comprised 403 patients per arm.

The phase 3, double-blind, randomized, parallel-group, multicenter study, sponsored by Samsung Bioepis, sought to demonstrate the comparable efficacy of SB3 (which has an identical primary amino acid sequence to TRZ) and TRZ in terms of bpCR when the products are used in neoadjuvant settings in women who have either epidermal growth factor receptor 2–positive early breast cancer or locally advanced breast cancer.

Patients who were 18 to 65 years of age and newly diagnosed with stage II to III primary breast cancer received either SB3 or the reference product for 8 treatment cycles, which were given concurrently with chemotherapy. The patients then underwent surgery and a subsequent 10 cycles of either SB3 or TRZ.

The study analyzed efficacy in a per-protocol set (PPS), comprising those who had completed neoadjuvant therapy and surgery without any prespecified major deviations from protocol, and also considered a full-analysis set to provide supportive data. Drawing upon several published TRZ studies as a guideline, the researchers set equivalence margins in the PPS at a 90% confidence interval (CI) of the ratio of bpCR rates for SB3 and TRZ, or a 95% CI of the difference between the bpCR rates for the 2 products. Secondary endpoints for the study included total pathologic complete response (tpCR), overall response rate (ORR), event-free survival, PK equivalence, immunogenicity, and safety.

The researchers found that, after adjusting results by hormone receptor status, disease stage, and region, the adjusted bpCR ratio for the PPS was 1.259 (90% CI, 1.112-1.426), a value that falls within the pre-defined margin of 0.785 to 1.546. The adjusted difference was 10.7% (95% CI, 4.13%-17.26%), with the lower margin contained within and the upper margin falling outside the predefined margin (–13% to 13%). The tpCR results were reflective of the bpCR findings, with an adjusted PPS ratio of 1.315 (90% CI, 1.137-1.520). Results for ORR also bore out bpCR results, with an adjusted ratio for the PPS at 1.055 (90% CI, 1.023-1.088).

Additionally, the study data demonstrate comparable safety between SB3 and TRZ, with neutropenia, alopecia, and nausea representing the most commonly reported adverse effects in both study arms. PK data demonstrated equivalent steady-state trough levels. Finally, immunogenicity was comparable between the 2 groups up to cycle 9 of treatment, with positive anti-drug antibody results reported for 3 patients in the group receiving SB3 and none in the group receiving TZB.

Although the report notes that complete safety and survival data will follow, the researchers concluded that SB3 and TZB had equivalent efficacy based on the ratio of bpCR rates and that SB3 was both well tolerated and comparable to TZB in safety, immunogenicity, and PKs.
REFERENCE

Pivot XB, Bondarenko I, Dvorkin M, et al. A randomized, double-blind, phase III study comparing SB3 (trastuzumab biosimilar) with originator trastuzumab in patients treated by neoadjuvant therapy for HER2-positive early breast cancer. J Clin Oncol. 2017;35(suppl; abst 509).
PDF
 
Copyright AJMC 2006-2017 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up
×

Sign In

Not a member? Sign up now!