At the Asco Congress positive data for adjuvant therapy developed by Novartis
Adjuvant therapy, i.e. following surgery, with ribociclib reduces the risk of recurrence by 25% in a large population of patients with early stage breast cancerAnd. These are the positive data from the primary endpoint of the pivotal phase III trial Natalee che Novartis presents today at ASCO annual congress (American Society of Medical Oncology). The data show that ribociclib in combination with endocrine therapy (ET), compared with endocrine therapy alone, reduces the risk of recurrence by 25.2% in a large population of patients with staged breast cancer. initial Hr positive/Her2 negative, regardless of disease stage, menopausal and lymph node status.
Ribociclib data were consistent across all secondary efficacy endpoints, including distant disease-free survival (26% risk reduction) and recurrence-free survival (28% risk reduction). , with a positive trend for overall survival. The safety profile of ribociclib at the 400 mg dose was also favorable, with limited rates of symptomatic adverse events and limited dosing treatment adjustments for up to three years. The most frequent adverse events were: neutropenia (43.8%) hepatic events, including increased transaminases (8.3%).
“In 2022, in Italy, they were estimated 55,700 new cases of breast cancer, the most frequent in the entire population – says Saverio Cinieri, president of Aiom (Italian Association of Medical Oncology) – The adjuvant therapy of radically operated disease can be considered one of the greatest successes in oncology in the last thirty years. In fact, despite the constant increase in cases, mortality decreased by 6.8% from 2015 to 2021, not only due to the effect of early diagnosis through screening programs, but also due to the effectiveness of adjuvant therapy. In fact, 5-year survival reaches 88% and places our country at the top of Europe. There are three adjuvant treatments: chemotherapy, hormone therapy and biological therapy, offered to patients on the basis of the study of the individual case, the characteristics of the neoplasm and the physical conditions of the woman”.
Unfortunately, however, “for many patients – Cinieri highlights – there are no effective tools to substantially reduce the risk of recurrence. Significant results from the Natalee study show ribociclib’s potential to change clinical practice. Furthermore, reducing recurrences means containing the considerable cost for the NHS in terms of drugs, visits and hospitalizations necessary when the disease becomes metastatic, in addition to the negative consequences on quality of life”.
“To reduce the risk of recurrence, patients with early stage breast cancer, positive for hormone receptors and Her2 negative, take the standard hormonal treatment lasting between 5 and 10 years, in addition or not to chemotherapy – explains Michelino De Laurentiis, director of the Department of breast and thoraco-pulmonary oncology, National Cancer Institute Irccs Foundation ‘G. Pascale’ of Naples -. In the Natalee study, involving over 5,000 patients, ribociclib was given for 3 years along with hormone therapy. In this way, the risk of recurrence was reduced by a further 25%, in a very large patient population, which also includes women without lymph node involvement”.
“We hope – this is the hope of the oncologist – that the availability of therapy will take place as soon as possible, because we will be able to offer an effective therapeutic opportunity to a large number of patients. About 70% of women have breast cancer with positive hormone receptors and Her2 negative and at least half have the characteristics of the patients included in the study.Therefore, about 20,000 women every year in Italy could benefit from this therapy, which has already shown to be very effective in the metastatic stage, guaranteeing a good quality of life ” .
“The most impactful event from a clinical point of view, in radically operated breast cancer – underlines Fabio Puglisi, director of the Department of Medical Oncology at the Irccs CRO of Aviano, full professor and director of the School of Specialization in Medical Oncology at the University of Studies of Udine – is the appearance of distant recurrences, which is associated with a dramatic prognostic deterioration. Patients with hormone receptor positive and Her2 negative early stage breast cancer remain at risk of recurrence, because the disease recurs in one third of cases initially in stage II and in half of those who started in stage III. Furthermore, 90% of recurrences that develop within 5 years lead to metastatic disease.”
The evolution of the disease from the initial stage to metastatic has negative repercussions “not only on survival – Puglisi remarks – but also on the patients’ quality of life. The data from the Natalee study represent a further step towards healing more patients. These findings may have a greater impact than previously achieved in adjuvant treatment with chemotherapy or aromatase inhibitor-based hormone therapy.”
“Following a diagnosis of early-stage breast cancer, patients live in constant fear that the disease may return – says Paola Coco, CSO & Medical Affairs Head, Novartis Italia -. Data from the Natalee study highlight the potential for ribociclib to reduce the risk of recurrence in this at-risk population, including patients with negative lymph nodes, while maintaining a favorable safety profile. These findings, which could change clinical practice, reinforce the well-established profile of ribociclib as a proven treatment in HR positive/Her2 negative metastatic breast cancer. We have always been at the forefront of research into therapies that improve the survival and quality of life of people affected by breast cancer and, today, our hope of achieving recovery in many patients diagnosed with early breast cancer is still bigger”.
Ribociclib was developed by Novartis Institutes for BioMedical Research (NIBR) through a research collaboration with Astex Pharmaceuticals. The Swiss pharmaceutical group expects to submit Phase III data to regulatory authorities in the United States and Europe later this year.