Samsung Bioepis Announces Four-year Follow-up Data for Biosimilar ONTRUZANT(trastuzumab-dttb) in Early or Locally Advanced HER2-positive Breast Cancer
- Data to be presented at the ASCO20 Virtual Scientific Program
- Four-year event-free survival (EFS) and overall survival (OS) rates demonstrate biosimilarity between ONTRUZANT??and reference trastuzumab
May 15, 2020 07:00 AM Eastern Daylight Time
INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. announced today that four-year follow-up results of the Phase 3 study for ONTRUZANT?, a biosimilar of the reference medicine HERCEPTIN?1?(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.
The four-year follow-up data is part of the ongoing follow-up study to assess cardiac safety and survival outcome in a subgroup of patients from the Phase 3 study who completed neoadjuvant and adjuvant therapy for one year. Among 875 patients from the Phase 3 study, a total of 367 patients were enrolled in the extension study, with a median follow-up of 53 months. During the follow-up period, cardiac safety was comparable between ONTRUZANT??(SB3) and reference trastuzumab (TRZ), with no occurrence of symptomatic congestive heart failure (CHF) and a very low incidence of asymptomatic significant left ventricular ejection fraction (LVEF) decrease (SB3, n=1; TRZ, n=2). Four-year event-free survival (EFS) rates and overall survival (OS) rates were also comparable between ONTRUZANT??and reference trastuzumab (EFS: SB3 83.4% vs. TRZ 80.7%; OS: SB3 94.4% vs. TRZ 89.6%). ?The four-year follow-up results further support comparable safety and efficacy profiles of ONTRUZANT to reference trastuzumab,? said Seongwon Han, Vice President, Medical & Lifecycle Safety Lead, Samsung Bioepis. He continued, ?We hope these findings on long-term safety and efficacy help build confidence in the use of biosimilars for prescribers and patients.? The poster of this study will be presented at the ASCO20 Virtual Scientific Program, as follows:?We hope these findings on long-term safety and efficacy help build confidence in the use of biosimilars for prescribers and patients.?
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- [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 a.m. ET
- 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
- 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
- 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
- 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
- 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
- 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
- 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
1?HERCEPTIN??is a registered trademark of Genentech Inc. |