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Comparability of biosimilar Ontruzant maintained over three years Posted 26/04/2019

Samsung Bioepis has presented positive long-term results for its trastuzumab biosimilar Ontruzant (SB3) at the 16th International Maternal Cancer Congress St Gallen 2019, which was held in Vienna, Austria.

South Korean biotechnology company Samsung Bioepis announced on 21 March 2019 that it had presented positive three-year follow-up data for its trastuzumab biosimilar, SB3. Samsung Bioepis says the ‘three-year follow-up data show comparable overall survival between biosimilar Ontruzant (trastuzumab) and reference medicine Herceptin (trastuzumab) in early and locally advanced HER2-positive breast cancer’.

The data come from an extension of a phase III trial in which patients received eight cycles of Ontruzant or Herceptin, together with neoadjuvant chemotherapy (prior to surgery). After surgery, they received 10 more cycles of Ontruzant or Herceptin. After completing the therapy, 367 participants (186 Ontruzant group and 181 Herceptin group) went on to participate in the follow-up study. The median follow-up from the start of treatment was 40.8 months in the Ontruzant group and 40.5 months in the Herceptin group.

Overall survival was 97% in the Ontruzant group and 93.6% in the Herceptin group. Event-free survival was 92.5% in the Ontruzant group and 86.3% in the Herceptin group (HR 0.49, 95% CI, 0.26‒0.91). With respect to adverse events, cardiac events were scarce in both treatment groups throughout the three-year follow-up period. There were three cases of significant reduction of the left ventricular ejection fraction (LVEF) asymptomatic (1 Ontruzant group and 2 Herceptin group), with all patients recovering with LVEF greater than or equal to 50%. There were no cases of symptomatic congestive heart failure, cardiac death or other significant cardiac conditions reported in either group.

Ontruzant (150 mg) received European Commission approval in November 2017 [1] and was approved by the US Food and Drug Administration in January 2019 [2]. In February 2019, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for a 420 mg vial presentation of Ontruzant.

Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis said that when Samsung Bioepis developed Ontruzant it ‘aimed to make one of the mainstays of modern cancer therapy more accessible for more people more quickly, and these long-term data underline the importance of that aim’.

Libbs Farmacêutica has also started a real-world study of their trastuzumab similar biotherapeutic product, Zedora, in Brazil.

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1. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 26]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Ontruzant 
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 26]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Ontruzant

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Source: ClinicalTrials.gov, Samsung Bioepis

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