“This is an exciting drug,” said Hope Rugo, MD, Professor of Medicine at University of California, San Francisco. “It is highly effective and extremely well tolerated, with no hair loss, which is very important to patients. It also enables using a lower dose of trastuzumab.”
Dr. Rugo cited these outstanding questions: What is the efficacy of T-DM1 in trastuzumab-resistant patient? What is the toxicity after therapy is stopped? In the study reported at the 2011 European Multidisciplinary Cancer Congress, patients were treated until disease progression. She said T-DM1 will probably be studied in the adjuvant and neoadjuvant setting. “We have to wait for results of EMILIA to validate this phase II study,” she commented. ■
Disclosure: Dr. Rugo has received research funding from Genentech.
Martine Piccart, MD, of the Institut Jules Bordet, Brussels, Belgium, and President-Elect of the European Society for Medical Oncology, was highly enthusiastic about the findings of the phase II T-DM1 study, but said, “We have to remember this is an open-label trial, and in a study like this,...