These are the “most positive results in the history” of breast cancer, according to the IBCC.
BARCELONA, March 24. (Benin News) –
The director of the International Breast Cancer Center (IBCC) and first author of the international clinical trial Destiny Breast-03, Javier Cortés, has pointed out that the drug “trastuzumab deruxtecan” “improves” progression-free survival of HER2 breast cancer -positive in 75.8% of patients.
The New England Journal of Medicine has published the results of the study, which Cortés says are “the most positive in the history” of breast cancer following analyzing the drug’s efficacy and safety, the agency said. IBCC in a statement Wednesday. In fact, the results with this drug have been “so positive” that “trastuzumab deruxtecan” has become, according to the IBCC, the new standard of second-line treatment for patients with HER2-positive breast cancer. .
Destiny Breast-03 studied the efficacy and safety of trastuzumab deruxtecan, the product of the Daiichi Sankyo – AstraZeneca alliance. The drug is an immunoconjugate or antibody-drug conjugate (ADC) that acts like a “Trojan horse”, bypassing tumor cell defenses to enter tumor cells and attack them by releasing its “load”.
This is an international, randomized, multicenter, phase III clinical trial conducted with the participation of 524 patients with HER2-positive metastatic breast cancer, recruited for this trial between July 20, 2018 and June 23. 2020 in 169 centers in 15 countries.
Of this total, 261 patients were randomized to the “trastuzumab deruxtecan” arm of the study and 263 to the standard treatment arm so far consisting of “trastuzumab emtansine” (TDM-1).
One of the “most important” results of the study is the improvement in progression-free survival (i.e. disease control), which was 75.8% in these patients at 12 months, compared to 34.1% in the group of patients treated with trastuzumab emtansine.
Overall survival at 12 months was 94.1% in patients in the trastuzumab deruxtecan group versus 85.9% in patients in the TDM-1 group, while the overall response rate was 79.7% with trastuzumab deruxtecan compared to 34.2% in the standard group, also comfortably higher with the new treatment compared to the old.
Tellingly, 42 patients (16.1%) treated with trastuzumab deruxtecan versus 23 (8.7%) with TDM-1 showed a complete response rate, which means that the tumor completely disappeared, at least visually.
“This drug is so innovative and so improves prognosis compared to current standard treatment that we might be in the presence of the most active drug in the history of breast cancer,” says Dr. Cortés, who predicts, albeit preliminary, that “it might cure the disease in certain patients, because the tumor disappears in 16% of the cases, or at least increase the real chances of chronification of the disease”.
However, like all treatments, it is not without toxicity. A significant side effect of trastuzumab deruxtecan is drug-related interstitial lung disease/pneumonitis (lung inflammation).
The rates of this interstitial lung disease or pneumonitis with trastuzumab deruxtecan were 10.5% versus 1.9% with TDM-1. However, close monitoring or follow-up of patients treated with trastuzumab deruxtecan makes it possible to detect, treat and control this adverse effect at an early stage in the vast majority of patients.
The preliminary results of Destiny Breast-03 were presented at the Presidential Session of the European Society for Medical Oncology (ESMO) Congress last September and their publication today in The New England Journal of Medicine confirms their “robustness”. .
“TROJAN HORSE”
Immunoconjugate which acts as a “Trojan horse” because it bypasses the defenses of tumor cells to penetrate and attack tumor cells by releasing its cargo, it is composed of a monoclonal antibody (trastuzumab), linked by a linker to molecules of chemotherapy (deruxtecan).
It is administered intravenously and travels through the blood to the tumor cells, where it recognizes the gateway of these malignant cells, in this case the HER2 receptor, enters undetected and releases the chemotherapy which it transports to destroy them, without damaging “as much” the other healthy cells.
CURRENT STATE OF DRUGS AND RESEARCH AREAS
Currently, there are already three immunoconjugated drugs approved in Spain for breast cancer: TDM-1 (the oldest and most used in the clinic), sacituzumab govitecan and, more recently, trastuzumab deruxtecan.
There are currently “dozens” of immunoconjugates in research and development and it is quite possible that new immunoconjugates for treating different types of breast cancer will be available to oncologists in the coming years.
For now, the results of “Destiny Breast-03” position trastuzumab deruxtecan as a second-line treatment for patients with HER2-positive metastatic breast cancer. The drug has already been approved by regulators for heavily pretreated patients.
“We hope that the European Medicines Agency (EMA) will soon modify the current label of trastuzumab deruxtecan and authorize its use in patients who have already received a line of treatment,” says Cortés.
Furthermore, given the exceptional results of the “Destiny Breast-03” study, the Spanish researcher predicts that “this drug will certainly progress towards the first line of treatment and localized tumors to even consider the de-escalation of chemotherapy treatment” .
Mr. Cortés clarified that research on trastuzumab deruxtecan in HER2-positive breast cancer is still ongoing and that throughout 2022 new data on toxicity, quality of life and efficacy of this promising drug once morest active brain metastases will be presented.
