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Mark D. Pegram, MD, from the Stanford Cancer Institute, describes research into the antibody-drug conjugate T-DM1, following its FDA approval in February as a treatment for HER2-positive metastatic breast cancer.
Mark D. Pegram, MD, a professor of medicine at Stanford University Medical Center and the director of the Breast Cancer Program at the Stanford Cancer Institute, describes research into the antibody-drug conjugate T-DM1 (trastuzumab emtansine), following its FDA approval in February as a treatment for HER2-positive metastatic breast cancer.
T-DM1 was approved following treatment with HER2-targeted and taxane-based therapies based on results from the phase III EMILIA trial comparing it to the combination of capecitabine and lapatinib. Overall, treatment with T-DM1 in the EMILIA trial resulted in a significant improvement in overall survival, progression-free survival, and response rates. This high degree of response for patient with advanced disease suggest the agent will also be beneficial in earlier lines of treatment, Pegram believes.
As such, researchers are examining T-DM1 in the neoadjuvant and adjuvant setting for patients with HER2-positive breast cancer. The phase III MARIANNE trial is looking at the agent as a first-line treatment for HER2-positive metastatic breast cancer with or without the addition of pertuzumab compared to the standard of trastuzumab plus chemotherapy. The second trial will examine T-DM1 in the adjuvant setting in combination with standard chemotherapy and pertuzumab.