Mylan and Biocon to Present New Data at the American Society of Clinical Oncology (ASCO) Annual Meeting Reinforcing the Efficacy, Safety and Immunogenicity of Ogivri™, the first biosimilar for Herceptin® approved by FDA
Mylan's Head of Global Biologics, R&D,
Following are session details:
- Abstract 110: Biosimilar trastuzumab-dkst monotherapy versus trastuzumab monotherapy after combination therapy: Toxicity, efficacy, and immunogenicity from the phase 3 Heritage trial
June 4, 2018, 9:45-11:15 a.m. CDT
- Session: The Arrival of Biosimilars
Hope S. Rugo, MD, University of California, San Francisco
- Location: Hall D1
- Link to abstract: http://abstracts.asco.org/214/AbstView_214_224369.html
In addition, data related to Mylan and
Details are as follows:
- Abstract e19028: Characterization and similarity assessment of a pegfilgrastim biosimilar MYL-1401H.
- Link to abstract: http://abstracts.asco.org/214/AbstView_214_227973.html
More information about the 2018 Annual Meeting can be found on the
About the HERITAGE Study
HERITAGE is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of the trastuzumab biosimilar trastuzumab-dkst (formerly known as MYL-1401O) versus branded trastuzumab. Eligible patients had centrally confirmed, measurable HER2-positive metastatic breast cancer without prior chemotherapy or trastuzumab for metastatic disease. Patients were randomized to receive either trastuzumab-dkst or branded trastuzumab with docetaxel or paclitaxel for a minimum of eight cycles. Trastuzumab was continued until progression. The primary endpoint is overall response at week 24 by blinded central evaluation using RECIST 1.1. Secondary endpoints include progression free survival, overall survival and safety. A sample size of 456 patients was calculated to demonstrate equivalence in overall response at week 24 for trastuzumab-dkst versus branded trastuzumab, defined as a 90% confidence interval for the ratio of best overall response within the equivalence margin (0.81, 1.24).The primary endpoint has previously been reported: the overall response rate in patients with HER2-positive metastatic breast cancer at week 24 was equivalent between the trastuzumab-dkst and trastuzumab groups (Rugo et al. JAMA. 2017;317:37-47).
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MYLAN: Christine Waller (Media), 724.514.1968, Email: firstname.lastname@example.org or Melissa Trombetta (Investors), 724.514.1813, Email: InvestorRelations@mylan.com; BIOCON: Seema Ahuja (Media), +91-80-2808-2222, M:+919972317792, Email: email@example.com or Saurabh Paliwal (Investors), +91 80 6775 2040; M:+91 95383 80801, Email: firstname.lastname@example.org