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Samsung Bioepis to Present New Data for Biosimilar ONTRUZANT® (trastuzumab-dttb) at the ASCO20 Virtual Scientific Program

May 13, 2020 at 5:00 PM ET

Two real-world data on trastuzumab biosimilar plus pertuzumab in HER2-positive breast cancer patients
Four-year follow-up data from the Phase 3 study of ONTRUZANT®

INCHEON, Korea – May 13, 2020 – Samsung Bioepis Co., Ltd. announced today that new data for ONTRUZANT®, a biosimilar of the reference medicine HERCEPTIN®  (trastuzumab), will be presented at the ASCO20 Virtual Scientific Program organized by the American Society of Clinical Oncology (ASCO), which will be held from May 29-31, 2020.

Two real-world data will be presented; a population-based real-world data evaluating the efficacy of combination of neoadjuvant chemotherapy (NACT) with pertuzumab and ONTRUZANT® in HER2-positive early breast cancer patients in Denmark, and the other real-world data evaluating safety and efficacy of ONTRUZANT® in combination with pertuzumab in patients with HER2-positive breast cancer patients in Austria. The four-year follow-up data of the Phase 3 study reports comparable cardiac safety and survival of ONTRUZANT® to reference trastuzumab.

“The safety and efficacy data of our trastuzumab biosimilar plus pertuzumab is of significance, as the use of combination therapy is increasing in the real-world setting.” said Seongwon Han, Vice President, Medical & Lifecycle Safety Lead, Samsung Bioepis. He continued, “We look forward to sharing our data with the oncology community and contributing to the conversation regarding the use of biosimilars.”

The following three abstracts will be presented on ONTRUZANT®:
• [577] Neoadjuvant chemotherapy (NACT) and HER2 double inhibition including biosimilar trastuzumab (Ontruzant) for HER2-positive early breast cancer: population based real-world data from the Danish Breast Cancer Group (DBCG) – Poster session (Poster 69)
• [e12520] Safety and clinical evaluation of dual inhibition with pertuzumab and trastuzumab in HER-2-positive breast cancer patients – Online publication only
• [578] Four-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 – Poster session (Poster 70)
* Poster sessions will be available on demand beginning Friday, May 29, 2020 at 8:00 AM ET

About ONTRUZANT® (trastuzumab-dttb)
ONTRUZANT® is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:
• As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
• As part of a treatment regimen with docetaxel and carboplatin
• As a single agent following multi-modality anthracycline-based therapy

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
* High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

ONTRUZANT® is indicated:
• In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer
• As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product
ONTRUZANT® is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Select Important Safety Information

• Administration of ONTRUZANT® can result in sub-clinical and clinical cardiac failure
• Evaluate left ventricular function in all patients prior to and during treatment with ONTRUZANT®. Discontinue ONTRUZANT® treatment in patients receiving adjuvant therapy and withhold ONTRUZANT® in patients with metastatic disease for clinically significant decrease in left ventricular function

Infusion Reactions; Pulmonary Toxicity
• Administration of ONTRUZANT® can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt ONTRUZANT® infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue ONTRUZANT® for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome

Embryo-Fetal Toxicity
• Exposure to ONTRUZANT® during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception 

Exacerbation of Chemotherapy-Induced Neutropenia

• In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab products in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not

Most Common Adverse Reactions
• The most common adverse reactions for trastuzumab products in breast cancer were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
• The most common adverse reactions for trastuzumab products in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

These are not all of the risks associated with ONTRUZANT®. For additional information on ONTRUZANT® indications, as well as Important Safety Information related to its use, including Boxed WARNINGS, please see the ONTRUZANT® Prescribing Information HERE

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, hematology and gastroenterology. For more information, please visit: and follow us on social media– Twitter, LinkedIn.


Na Yun KIM