INCHEON, Korea – March 21, 2019 – Samsung Bioepis Co., Ltd. today announced findings of a three-year follow-up study comparing biosimilar ONTRUZANT® (trastuzumab) and reference medicine trastuzumab in early or locally advanced HER2-positive breast cancer. The data, which show comparable overall survival and cardiac safety, were presented today at the 16th St. Gallen International Breast Cancer Conference 2019 taking place in Vienna, Austria.
“With the development of our biosimilar trastuzumab, we 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,” said Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. “We are committed to increasing access to high-quality, life-changing oncology medicines through the development of biosimilars to address some of oncology’s most pressing challenges.”
Participants enrolled in an initial Phase III study received eight cycles of the biosimilar trastuzumab or the reference medicine concurrently with chemotherapy in the neoadjuvant setting. Following surgery, they received additional 10 cycles of the biosimilar trastuzumab or the reference medicine. After completion of therapy, 367 of these participants (186 in the biosimilar trastuzumab group and 181 in the reference medicine group) were enrolled in the follow-up study. Median follow-up from initiation of study treatment was 40.8 months in the biosimilar trastuzumab group and 40.5 months in the reference medicine group.
Overall survival was 97% in the biosimilar trastuzumab group and 93.6% in the reference medicine group (HR 0.39, 95% CI, 0.14-1.12). Event-free survival was 92.5% in the biosimilar trastuzumab group and 86.3% in the reference medicine group (HR 0.49, 95% CI, 0.26-0.91). The incidence of cardiac events was rare for both treatment groups throughout the three-year follow-up period. There were three cases of asymptomatic significant left ventricular ejection fraction (LVEF) decrease (biosimilar trastuzumab, n=1; reference medicine, n=2), with all patients recovering with LVEF ≥ 50%. There were no cases of symptomatic congestive heart failure, cardiac death or other significant cardiac conditions reported in either group.
The poster of this study will be exhibited at the 16th St. Gallen International Breast Cancer Conference 2019, as follows:
ONTRUZANT® (trastuzumab) 150 mg was granted the European Commission (EC) Marketing Authorisation in November 2017 and was approved by the U.S Food and Drug Administration in January 2019. In February 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a 420 mg vial presentation of ONTRUZANT®iii. With the adoption of CHMP’s positive opinion for ONTRUZANT® 420 mg vial presentation, ONTRUZANT® will be available in two vial sizes in Europe, providing clinics with greater convenience and flexibility than the 150 mg vial presentation alone.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology and ophthalmology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.
i HERCEPTIN® is a registered trademark of Genentech Inc.
ii Pivot, X et al. 2019. 3-year Follow-up of a Phase III Study Comparing SB3 (trastuzumab biosimilar) and Reference Trastuzumab in HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting. St Gallen International Breast Cancer Conference, Vienna, Austria, 20-23 March 2019. [P156 Poster Session I, March 21, 2019]
iii European Medicines Agency – Committee for Medicinal Products for Human Use (CHMP). Final agenda for the meeting on 25-28 February 2019. Available at: https://www.ema.europa.eu/documents/agenda/agenda-chmp-agenda-25-28-february-2019_en.pdf. Last accessed February 2019.