BEFORE used only in metastatic melanoma. Then in the locally advanced one with a high risk of relapse. And now also for the very early stages. The data that has been accumulating for years now leave no doubt that immunotherapy is also effective – and more so – if given early. The goal is to increase the number of patients who recover from melanoma: very ambitious but, according to experts, achievable in light of the first results of the Keynote-716 study, presented at the Presidential Symposium Congress Esmo 2021 (European Society of Medical Oncology).
SPECIAL ESMO 2021
I study
The data show, in fact, for the first time, that in patients with stage II melanoma completely removed, but at high risk of relapse, immunotherapy with pembrolizumab increases disease-free survival. In more detail, the use of pembrolizumab as adjuvant therapy (after surgery) reduced the risk of disease recurrence or death by 35% compared to placebo. The study involved over 970 patients, half treated with immunotherapy and the other half with a placebo (since there is no adjuvant treatment for these patients). In both groups, the median relapse-free survival was not reached at the time of data analysis. At 14.4-month follow-up, 11.1% (54 out of 487) of patients treated with pembrolizumab experienced relapse or death, compared with 16.8% (82 out of 489) of patients treated with placebo , with fewer distant relapses with pembrolizumab (4.7%, 23 out of 487) compared to placebo (7.8%, 38 out of 489).
Regarding side effects, the safety profile of pembrolizumab was consistent with previously reported studies in patients with solid tumors. Adverse effects occurred in 79.9% of patients treated with pembrolizumab compared to 60.9% of patients treated with placebo, while the most important, Grade 3 or 4, were observed in 16.1% and 4, 3%, respectively.
Melanoma, early stage immunotherapy also works in the real world
The goal of healing
“The KEYNOTE-716 study is the first to demonstrate the efficacy of an immunotherapy treatment in the very early stages of melanoma”, comments Paolo Ascierto, Director of the Melanoma Oncology, Oncological Immunotherapy and Innovative Therapies Unit of the ‘Pascale’ of Naples: “L Adjuvant immunotherapy, i.e. after surgery, is an established option in resected stages III and IV. The stage IIB and IIC population deserves particular attention because it presents, after complete resection, an even greater risk of recurrence than stage IIIA patients. But, to date, no systemic treatment options are available for these patients and the standard of care is observation. Bringing immunotherapy in the very early stages means increasing the number of patients who reach the goal of recovery ”.
Immunotherapy: Doctors confident for use on early stage cancers
by Irma D’Aria
Immunotherapy for the earliest stages: many studies in progress
The results were accepted for priority review by the Food and Drug Administration: “The KEYNOTE-716 study was conducted to evaluate whether adjuvant pembrolizumab, already recognized stage III resected therapy, could prolong relapse-free survival in patients. with resected high-risk stage II melanoma, ”says Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories:“ These results, which show a significant 35% reduction in the risk of recurrence of disease or death compared to placebo, suggest early use of pembrolizumab ”. Many cancers are considered more treatable and potentially curable in the early stages of the disease. MSD is currently conducting studies with pembrolizumab in its early stages, with approximately 20 pivotal studies underway in different types of cancers.
randomly 2021
The combination of immunotherapies works on several cancers
by Letizia Gabaglio
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