Clinical Trials Remain Underway for Trastuzumab Deruxtecan in HER2-Positive Breast Cancer

July 30, 2020

Ian E. Krop, MD, PhD, discusses the importance of clinical trials further exploring the role of trastuzumab deruxtecan following the FDA’s approval of the agent as treatment of patients with HER2-positive metastatic breast cancer.

Ian E. Krop, MD, PhD, an associate professor of medicine with Harvard Medical School; associate chief, Division of Breast Oncology with Susan F. Smith Center for Women's Cancers; and a medical oncologist and clinical research director with the Breast Oncology Center at Dana-Farber Cancer Institute, discusses the importance of clinical trials further exploring the role of trastuzumab deruxtecan (Enhertu) following the FDA’s approval of the agent as treatment of patients with HER2-positive metastatic breast cancer.

The agent was granted an accelerated approval in December 2019 for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who had received at least 2 prior lines of HER2-directed therapies in the metastatic setting. The approval was based on findings from the phase 2 DESTINY-Breast01 clinical trial.

There are currently phase 3 clinical trials underway evaluating trastuzumab deruxtecan in the second-line setting compared with TDM-1. There is also a confirmatory trial comparing this agent with the physician’s choice of treatment as a HER2-directed therapy in the third-line and later settings, Krop says.

With larger data sets from these clinical trials, we can learn more about how pneumonitis plays out now that physicians are aware of this side effect. In a head-to-head comparison, physicians can also determine how this treatment compares with our current standards of care, Krop concludes.

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