MILAN (ITALPRESS) – Novartis has announced the results of the follow-up analysis at 6 years of the Phase III Natalee study, which demonstrate the clinically significant benefit in terms of global survival given by the combination of endocrine rebocycling and therapy (ET) compared to ET alone. The study was conducted in the wider population of patients with breast cancer HR+/HER2 in the initial phase (eBC), in stage 2 and 3, at high risk of relapse, including patients with high-risk lymph node-negative disease and all patients with lymph node involvement. Novartis CDK4/6 inhibitor in association with endocrine therapy (ET) has reduced the risk of death by about 20% (19.1%) compared to ET alone with a benefit in terms of global survival consistent in all major subgroups.
The results were presented at the Annual Congress of the European Society for Medical Oncology (Esmo). At the time of the analysis, patients no longer received the CDK4/6 inhibitor of Novartis for a three-year, 38-month average period, and had exceeded the five-year duration of endocrine therapy provided by the protocol. The absolute benefit in terms of survival free from invasive disease has increased from 4.1% to five years to 5.3% to six years, strengthening the evidence of the long-term value of the association between the CDK4/6 inhibitor and endocrine therapy. In addition, a lower number of patients treated with the CDK4/6 inhibitor of Novartis in association with endocrine therapy (ET) has developed a metastatic relapse compared to patients treated with the ET alone; also the benefit in terms of global survival has continued to increase over time, with an absolute difference from 1.2% to five years to 2.1% to six years.
The specific survival results for breast cancer (BCSS) are consistent with the benefit observed in terms of global survival, showing a reduction of about 30% of the specific death risk for breast cancer (HR=0.709; 95% CI: 0.559-0.890) compared to ET alone. “It’s just on occasions like the Esmo Congress that we see how innovation can change the natural history of a disease,” says Giuseppe Curigliano, ordinary professor of Medical Oncology at the University of Milan and director of the New Pharmacy Development Division for Innovative Therapies at the European Institute of Oncology, elected president of the European Society for Medical Oncology (Esmo). “The results at six years of Christmas study and demonstrate a clinically significant benefit in terms of global survival with this molecule in association with endocrine therapy. These are particularly important evidences because they are obtained in the wider population of high-risk patients studied to date in this setting, including patients with high-risk lymph node-negative disease,” he continues. “If fully valued, this innovation could offer more than 10,000 patients in Italy every year a new opportunity to reduce the risk of relapse and look to the future with greater confidence,” he concludes. The CDK4/6 inhibitor of Novartis is the only one in the class to have demonstrated a statistically significant benefit in terms of overall survival in three randomized and controlled trials, Monaleesa-2, Monaleesa-3 and Monaleesa-7, in the tumor of the metastatic breast and a clinically significant benefit in terms of global survival in the wider population of patients with breast cancer in the initial phase at high risk of resonant patients.
“It is particularly significant to see how the benefit of this molecule in terms of global survival, already demonstrated in advanced disease, is also reflected in the early stage. The six-year data from the Christmas study indicates that adding this CDK4/6 inhibitor to adjuvant endocrine therapy can make a concrete difference for the future of patients, with an advantage that continues to grow even years after the conclusion of treatment. It is also encouraging that the benefit is consistent in a wide range of high-risk patients, with and without lymph nodal involvement. The tolerability profile is manageable, with adverse events mainly of labs and asymptomatics: an important aspect to support adherence and therapeutic continuity”, explains Michelino De Laurentiis, Director of the Department of Senological Oncology and Toraco-Polmonare, National Institute of Tumori IRCCS Foundation “G. Pascale” of Naples.
In Italy, is the CDK4/6 inhibitor of Novartis reimbursed in association with adjuvant endocrine therapy for the treatment of patients with breast cancer HR+/HER2? in the initial phase with lymph nodal involvement and high risk of relapse. “For more than 35 years, Novartis has been involved in research to reimagine breast cancer treatment, with the aim of offering an ever greater number of patients the concrete possibility of a future free from the disease. The results at six years of the Christmas study represent a further step in this direction: the clinically significant benefit in terms of global survival observed in the wide population of high-risk patients highlights the advantage of being able to intervene early and translate scientific innovation into long-term prospects for patients“, says Marco Rago, Medical Head Oncology of Novartis Italy.
– Novartis press office photos –
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