ESMO 2025 | REALITY-01: final results of real-world T-DXd in HER2+ metastatic breast cancer
Jean-Yves Pierga, MD, Institut Curie, Paris, France, discusses final real-world safety and efficacy of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive metastatic or unresectable breast cancer receiving two or more prior treatment lines from the Phase IV REALITY-01 study (NCT05149014). T-DXd demonstrated meaningful clinical activity, with a substantial proportion of patients achieving objective responses, including complete responses, and encouraging median progression-free survival. Safety was consistent with known profiles, with most adverse events manageable through dose adjustments or interruptions. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
That was a collection of data about patients treated in an early access program in France to the trastuzumab-deruxtecan for HER2-positive metastatic breast cancer receiving at least two lines of treatment before receiving T-DXd. And so the idea was to collect data on efficacy, but also tolerance and side effects in this population, which was not selected and was just based on the early access in France...
That was a collection of data about patients treated in an early access program in France to the trastuzumab-deruxtecan for HER2-positive metastatic breast cancer receiving at least two lines of treatment before receiving T-DXd. And so the idea was to collect data on efficacy, but also tolerance and side effects in this population, which was not selected and was just based on the early access in France. So at the end, the results were obtained in 305 patients treated in this cohort. And the main results showed that the results in terms of overall response rate and progression-free survival were quite comparable to the DESTINY-Breast01 trial, which was a phase two initial trial, which was based on the approval of Trastuzumab-deruxtecan and the early access. And then it shows that also the side effects, the tolerability of the drug was according to what was already published and shown in a non-selected population. And we had also patients, elderly patients aged more than 70 years and also patients with low performance status, high performance status. So also this patient tolerated quite well the treatment and then they were accessible to this kind of drug.
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