TODAY a new benchmark is set in the history of metastatic breast cancer. The MONALEESA 2 study, presented at the European congress of medical oncology (ESMO), brings the hope of survival to over 5 years. It means that 50% of patients with stage IV breast cancer of the most common type, hormone-sensitive, can live longer than this time. Sometimes much more. It is a milestone in precision medicine, as Myriam Mendila, Chief Medical Officer of Novartis Oncology and Head of Global Medical Affairs at Novartis tells us: of molecularly targeted drugs and their best combination with other drugs developed in 30 years of research. In a path of treatment that is getting longer and longer but, obviously, it is never long enough. And that must also safeguard the quality of life.
Myriam Mendila, what is the importance of the results of the MONALEESA-2 study?
“It is the first time that there is overall survival data for the first-line combination of a CDK4 / 6 inhibitor with an aromatase inhibitor, one of the most used drugs in postmenopausal women with ER-positive breast cancer. and HER2-negative (the most common type of breast cancer, ed.). Importantly, the longest median overall survival to date was observed with this combination not only in this patient population, but in metastatic breast cancer in general: 64 months, or more than 5 years. This is an increase in median survival of more than one year compared to treatment with the aromatase inhibitor alone. Finally, this is the third clinical study of ribociclib in advanced breast cancer to achieve statistically significant and clinically important results. These data represent a new benchmark in metastatic breast cancer “.
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In your opinion, what is the realistic message to be given to women who are diagnosed with metastatic breast cancer today?
“Over the past thirty years, median survival has gone from about 2 years to 4. There have been many improvements, but still few for these women. Achieving a median survival of 5 years or more is unprecedented and is a message of new hope. It is also important to point out that these therapies do not worsen the quality of life. Updated data from MONALEESA Program studies show that the quality of life is maintained or, in many cases, improves. It means being able to give the best survival ever with a positive impact on the quality of life. MONALEESA 2 has the longest follow up of any other CDK4 / 6 inhibitor: six and a half years. By now we are well aware of the possible adverse effects and we know how to manage them “.
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Do the “real world” data from clinical practice confirm what has been observed in clinical studies?
“There is a lot of data coming from clinical practice, both published and presented at other conferences. Essentially, they confirm the significant impact of ribociclib and the class of CDK4 / 6 inhibitors on survival: what we see in clinical trials can also be translated into the real world setting “.
Are there patients who respond better than others?
“The overall survival and disease-free survival benefits were observed in all subgroups of ER positive HER2 negative breast cancer, both luminal A and luminal B. Earlier this year, an interesting hypothesis emerged about the possibility to observe different drug activities based on the expression profile of 50 tumor genes. But, as mentioned, the MONALEESA Program has shown that the drug is active in all subgroups “.
CDK4 / 6 inhibitors have already changed clinical practice in metastatic breast cancer, both pre- and postmenopausal. Are there also positive data for early stage cancer?
“For about two years we have been testing ribociclib in patients with early stage breast cancer, as adjuvant therapy after chemotherapy, in the NATALEE phase III clinical trial. These are patients with stage II and III cancer with an intermediate to high risk of relapse. The trial is testing a three-year ribociclib therapy with two dosages: the same tested in the metastatic and lower. We completed the recruitment last April and we expect the results at the end of next year or the beginning of 2023. We think there will be important benefits in these patient populations too ”.
What’s the next step?
“One of the open questions is how to optimally treat patients with ER-positive and HER2-positive tumors. The big question, however, is obviously how to heal women with metastatic cancer. Today we are able to cure early stage cancer very well, but achieving healing in those who are metastatic is really a rare event. This is our goal. We have other drugs in our pipeline, such as alpelisib (already approved in the US and Europe, ed.) For which we have a robust clinical development program ”.
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