An Italian study demonstrates how well the treatment works on patients in the real world and not only those carefully “selected” to participate in the trials: it reduces the risk of relapse and prevents metastases
What happens when a new drug, tested for a long time on patients carefully “selected” to participate in the trials that led to its approval, is then actually used in the real world, that is, on people who are often older, frail and “suffering” for away from the numerous concomitant ailments? It often happens that the new treatment is a little more toxic, difficult to tolerate at full dosage, in a heterogeneous and unselected population compared to that of clinical studies. As for patients with an advanced stage melanoma, however, an Italian study shows that the efficacy and tolerability of an immunotherapy drug, nivolumab, on the other hand, they remain unchanged.
Reduce the risk of recurrence and prevent metastases
The results of the survey presented at the annual congress of the European Society for Medical Oncology (Esmo) concern 611 patients, with resected stage III and IV melanoma, i.e. when the disease has been completely removed, in which immunotherapy was used at an early stage to reduce the risk of recurrence and prevent metastasis. “The results concern the extended access program to nivolumab that was activated in Italy before this strategy was then approved by the Italian Medicines Agency (in December 2019) – he explains Paolo Ascierto, director of the Unit of Oncology, Melanoma, Oncological Immunotherapy and Innovative Therapies at the Pascale Cancer Institute of Naples -. The participants had been enrolled between November 2018 and June 2019 and had different characteristics than those of the pivotal study because, for example, they were more frail, elderly or with other concomitant pathologies. It is the largest program in the world on the use of early phase immunotherapy in daily clinical practice and consolidates the value of nivolumab: two years after adjuvant therapy (which currently lasts 12 months), Relapse-free survival reached 58% of patients and distant metastasis-free survival 70%“. In patients with this stage IIIB or IIIC tumor, not subjected to adjuvant therapy after surgical resection, the 5-year relapse rate is instead high, equal to 71% and 85%.
Goal healing
In 2020, in Italy, they were almost estimated 14,900 new diagnoses of melanoma. The numbers speak for themselves: a handful of years ago, in 2011, only one in four patients with advanced melanoma was still alive one year after diagnosis. Today 65% are over two years old. And the prospect to prepare for from now on is that about half of the people who are discovered this type of skin cancer already in the metastatic phase will be “chronic”, that is, they will live with the disease for a long time. Indeed in 10 years, in Italy, people alive after the diagnosis of melanoma have increased by almost 70%: there were 100,910 in 2010, 169,900 in 2020. “Today immunotherapy molecules represent the standard of care for melanoma not only in the metastatic phase, but also in the resected stage III and IV – underlines Ascierto -: adjuvant immunotherapy lasts only a year, the possibility of avoiding the recurrence of the disease increases and, therefore, potentially of healing the person “.
The best sequence of therapies is being studied
At Esmo 2021, the preliminary results of the (phase 2) SECOMBIT study were also presented for the first time, which enrolled 209 people from 30 centers in 10 European countries with the aim of identifying the right sequence of therapies in people with metastatic melanoma who have the BRAF gene mutation. “The trial experiments with three options to identify the best sequence – explains the expert, who is the main investigator of the study -. The first is the combination of target therapies to continue with the combination of two immuno-oncological molecules (nivolumab and ipilimumab) after disease progression. The second option is dual immunotherapy to continue with the combination of target therapy as the cancer progresses. Finally the so-called “andwitch arm”, that is the sequence of target therapies and the combination of the two immunotherapies and, only in case of progression, continuation with target therapies. Data is available at a median follow-up of 32 months and the second option achieves the best 3-year overall survival of 62% compared to starting with the target therapy (54%) or the third option (60%). Preliminary data also indicate a progression-free survival, three years, of 53% starting with the combination of nivolumab and ipilimumab compared to 41% with molecular target therapy and 54% with the third option ”.
September 21, 2021 (change September 21, 2021 | 11:01 am)
© Time.News