IT WAS THE FIRST presentation made today at the Presidential Symposium of the Esmo 2021 Congress because the data are one of the good news coming from this European event in which many patients place hopes for new possible treatments that can change their history of disease. Such as the data on the monoclonal antibody trastuzumab deruxtecan which in patients with Her2 + metastatic breast cancer reduced the risk of disease progression or death by 72% compared to trastuzumab emtansine, the currently approved treatment for the treatment of patients with Her2 breast cancer. – unresectable and / or metastatic positive previously treated with trastuzumab and taxane. Breast cancer remains the most common cancer in the world and is a leading cause of cancer death in women. More than two million cases of breast cancer were diagnosed in 2020, with nearly 685,000 deaths globally. About one in five cases of breast cancer are considered Her2 positive.
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The interim results
In an interim analysis of the phase 3 Destiny-Breast03 study, trastuzumab deruxtecan, the anti-Her2 drug-conjugated monoclonal antibody (ADC) from Daiichi Sankyo and AstraZeneca, demonstrated a 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine (T-DM1). After 15.5 and 13.9 months of follow-up in the trastuzumab deruxtecan and T-DM1 treatment arms, respectively, the median progression-free survival for patients treated with trastuzumab deruxtecan was not achieved compared to 6.8 months for T-DM1 as per independent central blinded review.
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Three and a half times greater progression-free survival
But in the analysis of the key secondary endpoint of progression-free survival as assessed by the investigators, patients treated with trastuzumab deruxtecan achieved a three-and-a-half-fold improvement with survival of 25.1 months compared to 7.2 months with current therapy. Not only that: a consistent progression-free survival benefit was observed in key subgroups of patients treated with trastuzumab deruxtecan, including those with a history of stable brain metastases. The overall survival data is also good: almost all patients treated with trastuzumab deruxtecan were alive at one year, or 94.1% compared to 85.9% of those in the T-DM1 arm.
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A new standard of care
Furthermore, in the trastuzumab deruxtecan arm, the objective response rate (i.e. the percentage of patients, relative to the total number of subjects enrolled who obtain a complete or partial response) is more than doubled compared to the T-DM1 arm, with percentages of 79, 7% compared to 34.2%. “Patients with Her2-positive metastatic breast cancer who have undergone previous therapies typically experience disease progression in less than a year with currently available treatments,” he explained. Javier Cortes, Head of the International Breast Cancer Center in Barcelona. “The large and consistent benefit found across all key efficacy endpoints and subgroups of patients who received trastuzumab deruxtecan in Destiny-Breast03 are remarkable and support the potential of trastuzumab deruxtecan to become the new standard of care for previously treated patients. for Her2-positive metastatic breast cancer “.
The potential of molecularly targeted drugs
In the study, the safety profile of the most common adverse events with trastuzumab deruxtecan was consistent with previous clinical studies, with no new safety signals identified. “The observed benefit is greater than ever seen in breast cancer. Not only will the standard of care change, but it demonstrates the enormous potential of this class of molecularly targeted drugs, whose prospects appear bright both in terms of their use at an increasingly early stage, and in terms of the development of new molecules within of the same class, ”he commented Giampaolo Bianchini, head of the Mammella Group, Irccs S. Raffaele Hospital in Milan, the center that in Italy has enrolled the largest number of patients in the Destiny Breast-03 study.
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The other studies
Esmo was also presented with the updated results of the pivotal phase 2 Destiny-Breast01 study, in which trastuzumab deruxtecan continued to demonstrate marked efficacy and lasting responses in patients with Her2-positive metastatic breast cancer previously treated with two or more therapeutic regimens. anti-Her2. With a median follow-up of 26.5 months, a sustained increase in response was observed in patients treated with trastuzumab deruxtecan, with an updated objective response rate of 62%. Median progression-free survival was 19.4 months. In an exploratory analysis of overall survival with a median follow-up of 31.1 months, assessed with higher data maturity, the updated median overall survival was 29.1.