Samsung Bioepis Announces Results of Additional One-Year Follow-Up Study Comparing Event-Free Survival of SB3 Trastuzumab Biosimilar Candidate to Reference Trastuzumab by ADCC Activity

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced the results of an additional
one-year follow-up study comparing event-free survival (EFS) of SB3, a
biosimilar candidate referencing HERCEPTIN® 1 (trastuzumab),
to reference trastuzumab (TRZ) by antibody-dependent cell-mediated
cytotoxicity (ADCC) activity. ADCC is a key mechanism of action for
trastuzumab. The study results are being presented at the 2018 San
Antonio Breast Cancer Symposium® (SABCS) which is being held
December 4-8, 2018 in San Antonio, Texas.

For the study, patients with HER2 positive early or locally advanced
breast cancer were randomly assigned to receive SB3 or TRZ concurrently
with chemotherapy. Patients then underwent surgery followed by treatment
with SB3 or TRZ. Following completion of such therapy, 367 patients
participated in a long-term follow-up study, 186 of whom were treated
with SB3 and 181 of whom were treated with TRZ. Within the group of 181
patients who received TRZ, 126 patients who were exposed to at least one
kit from the TRZ lots with expiry dates between August 2018 and December
2019 during neoadjuvant period were considered “Exposed,” while the
remaining 55 patients were considered “Unexposed.” Upon monitoring the
quality attributes of TRZ for the development of SB3, a marked downward
shift in ADCC activity was observed in some of the TRZ lots with expiry
dates between August 2018 and December 2019.

Following 30.1 months of SB3 treatment and 30.2 months of TRZ treatment,
there was no statistically significant difference in EFS between SB3
(96.7%) and the Unexposed arm (98.2%) (HR 1.19, 95% CI 0.23-6.18;
p-value=0.8376). However, the results did show statistically significant
difference in EFS between the Unexposed (98.2%) and Exposed (92.5%) arms
within the TRZ treatment group (HR 0.07, 95% CI 0.01-0.58,
p-value=0.0137). In addition, while there was no statistically
significant difference in events between SB3 (4.8%) and the Unexposed
(3.6%) arms, there was statistically significant difference in events
within the TRZ treatment group between the Unexposed (3.6%) and Exposed
(10.3%) arms. An event was defined as disease recurrence or progression,
or death due to any cause. The study authors are currently looking into
longer-term effects of SB3 and hope to publish these results at a later

“This study builds on the robust evidence for SB3, and demonstrates the
trastuzumab biosimilar candidate’s comparable efficacy and safety
profiles to the reference biologic over a longer time period,” said Chul
Kim, Senior Vice President and Head of Clinical Science, Samsung
Bioepis. “We remain committed to advancing our strong pipeline of
biosimilar candidates, so that more patients and healthcare systems may
be able to benefit from biosimilar medicines.”

The poster for this study will be exhibited at SABCS, as follows:

    SESSION 6, December 8, 2018, 07:00AM – 09:00AM]

About Samsung Bioepis Co., Ltd.

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, ophthalmology and hematology.
Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen.
For more information, please visit: www.samsungbioepis.com.


1 HERCEPTIN® is a registered
trademark of Genentech Inc.


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