2023-07-05 13:05:00
The American Eli Lilly announces that Aifa, the Italian Medicines Agency, has approved with decision n. 415/2023 the reimbursement of abemaciclib in combination with endocrine therapy (ET, endocrine therapy) for the adjuvant treatment of adult patients with hormone receptor (Hr) positive, human epidermal growth factor type 2 (Her2), lymph node-positive and at high risk of recurrence.
“We talk about early stage breast cancer when there has been no metastatic spread, i.e. there are no distant metastases – explains Lucia Del Mastro, full professor of medical oncology at the University of Genoa, clinical director of medical oncology at the Irccs hospital Policlinico San Martino di Genova – After surgery, the post-operative treatment, the so-called adjuvant treatment, is decided on the basis of a series of factors that help us understand the risk that these women may develop metastases. 15% of Hr+/Her2- tumors are at increased risk of developing metastases and the possibility of offering these women an additional treatment to endocrine therapy, represented by abemaciclib, is a very relevant opportunity for our patients, who thanks to this drug have a clinically very significant reduction in the risk of recurrence”.
Aifa’s approval is based on results from the Phase 3 monarchE trial which met its primary endpoint at the second interim efficacy analysis, showing a statistically significant improvement in invasive disease-free survival compared with treatment. standard. The trial investigated the efficacy of the combination of abemaciclib and standard endocrine therapy, versus ET alone, in a specific population with disease characteristics at high risk of recurrence. The results of the study were monitored after the achievement of the primary endpoint and confirmed the superiority of adding abemaciclib to standard treatment, describing a reduction in the risk of recurrence over time that decreased from 32% to 35%.
The 4-year data from the monarchE trial, published in the ‘Lancet Oncology’ – continues the note – demonstrated that abemaciclib associated with endocrine therapy, compared with ET alone, in cohort 1 reduces the overall risk of disease recurrence by 35% and the risk of distant disease recurrence of 35%, with an increasing and sustained benefit demonstrated over the 2-year treatment period with abemaciclib. The 4-year invasive disease-free survival rate was 85.5% for patients treated with abemaciclib plus ET versus 78.6% for patients treated with ET alone, an absolute difference of 6.9% . In addition, the 4-year disease-free survival rate was 87.9% for patients treated with abemaciclib plus endocrine therapy compared with 81.8% for patients treated with Et alone, with an absolute difference of 6.1%. Finally, a subgroup analysis of the study was presented at the recent Asco annual meeting in Chicago, demonstrating consistent efficacy across age groups and in dose-adjusted patients.
“Treatment with abemaciclib in combination with endocrine therapy – says Valentina Guarneri, full professor of medical oncology and director of the School of Specialization in Medical Oncology at the University of Padua – has shown to significantly reduce the risk of recurrence in patients with breast cancer in early stage, but with a high risk of disease recurrence.At the various follow-up updates of the monarchE trial, we observed not only the maintenance of the reduction in the risk of recurrence that we had already seen in the primary analysis, but over time observed a tendency even to improve this effect.The fact that there is a reduction effect on the risk of distant metastases is an absolutely relevant aspect, because we know that the distant metastasis event is the one that most affects the prognosis of these patients. So what we expect is that this treatment will be able to increase the proportion of patients recovered.”
The monarchE study involved 5,637 Ebc Hr+/Her2- node-positive patients at high risk of recurrence enrolled in over 600 centers in 38 countries. The high risk of recurrence was defined according to specific disease characteristics, such as the presence of ≥4 positive axillary lymph nodes or 1 to 3 positive lymph nodes and at least one of the following criteria: tumor size ≥5 cm, histological grade 3 or Ki-67 index ≥20%. Patients were treated with abemaciclib in combination with endocrine therapy for 2 years. The approvals of the European Medicines Agency Ema and Aifa are related to the criteria of cohort 1 of the study, therefore to cases of disease with pathological characteristics of 4 or more positive axillary lymph nodes or from 1 to 3 with positive lymph nodes together with one of the following criteria: tumor ≥5 cm in size and/or histological grade 3.
In Italy – concludes the note – abemaciclib was already approved and reimbursed by AIFA since 2019 for the treatment of women with locally advanced or metastatic breast cancer, hormone receptor positive and human epidermal growth factor receptor negative type 2, in combination with an aromatase inhibitor or fulvestrant, as initial endocrine therapy or in women who have received prior endocrine therapy. In pre- or peri-menopausal women, endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
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