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Study Design: The Heritage Trial
The HERITAGE trial: Designed per FDA guidelines to detect any potentially clinically meaningful difference between OGIVRI® and reference trastuzumab9
A confirmatory, double-blind, phase 3 equivalence trial in patients with HER2+ metastatic breast cancer10
Study Endpoints
- Primary endpoint was week 24 ORR (complete and partial response )10
- Other endpoints included adverse events, LVEF, and immunogenicity at week 24 and 48 and PFS and OS at month 36 2,10
- Demographic, disease, and baseline characteristics were similar between treatment groups with no clinically relevant differences observed.10
The Heritage Study experience… could serve as a blueprint for development of other biosimilar products.11LVEF: Left ventricular ejection fraction; ORR: Overall response rate; OS: Overall survival; PFS: Progression-free survival
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Statistical therapeutic equivalence in ORR at 24 weeks10
Primary end point of ORR met at 24 weeks.
ORR ratio (1.09; 90% CI: 0.974–1.211) and ORR difference (5.53; 95% CI: −3.08–14.04) were within the defined equivalence boundaries*
*ORR ratio 90% CI equivalence boundaries were defined as 0.81 to 1.24 and ORR difference equivalence boundaries were defined as -15% and 15%.
Findings in the HERITAGE Trial are comparable to other recent multicenter studies of trastuzumab + taxane in HER2+ patients.11CI: Confidence interval; ORR: Overall response rate
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First FDA-approved trastuzumab biosimilar with PFS at 36 months
No significant differences in PFS to reference trastuzumab at 36 months
OGIVRI(n=230) Reference trastuzumab (n=228) Median PFS 11.1 11.1 Unstratified HR (95 % CI) 0.98 (0.78-1.24) CI: Confidence interval; HR: Hazard ratio; ITT1: Intention-to treat-1; PFS: Progression-free survival
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First FDA-approved trastuzumab biosimilar with OS at 36 months
No significant differences in OS to reference trastuzumab at 36 months
OGIVRI(n=230) Reference trastuzumab (n=228) Number of events 109 114 Median OS 35.0 30.2 HR (95 % CI) 0.90 (0.69-1.17)