In patients operated on for early stage melanoma, immunotherapy after chemotherapy can reduce the risk of metastasis by 36%. The figure emerges from the KEYNOTE-716 study, which investigated the benefits of pembrolizumab as an adjuvant therapy (i.e., for the prevention of relapses) for one year.
The new data
The new analysis, presented at the congress of the American Society of Clinical Oncology (ASCO), concerns patients with resected stage IIB and IIC melanoma: at a follow-up (median) of 27.4 months, pembrolizumab demonstrated a statistically significant and clinically relevant in distant metastasis-free survival compared to placebo. Furthermore, the general reduction in the risk of relapse was confirmed: 81.2% of patients were free from relapses two years after treatment, compared to 72.8% in the control group. Quality of life was similar in the two arms of the study.
even 2021
Melanoma, anticipating immunotherapy reduces the risk of relapse
by Tiziana Moriconi
21 September 2021
How the cure changes
Melanoma is the most aggressive skin cancer. Metastatic melanoma (stage IV) was the first malignancy in which the importance of immunotherapy was demonstrated. In recent years it has been shown that immunotherapy can also be effective as an adjuvant therapy in locally advanced melanoma with a high risk of relapse (fully resected stage III). As previously shown, the KEYNOTE-716 study indicates that immunotherapy is effective even earlier, in the earliest stages. “Patients with stage IIB and IIC melanoma have similar survival to that seen in stage IIIB patients, but unlike the latter, they have no systemic treatment options available and the only possibility so far has been represented by ‘ observation ”, explains Paolo Ascierto, Director of the Melanoma Oncology Unit, Oncological Immunotherapy and Innovative Therapies of the ‘Pascale’ of Naples. The relapse rates of resected melanoma in patients with stage IIB and IIC disease, in fact, are estimated to be around 32-46% and 39-74% in stage III patients. 5-year survival rates (according to the American Joint Committee on Cancer system – eighth edition) are estimated at 87% in stage IIB, 82% in stage IIC, 93% in stage IIIA, 83% in stage IIIB, by 69% in stage IIIC and 3 by 2% in stage IIID.
Melanoma: 48% of patients alive at 7 1/2 years with the combination of immunotherapy
by Irma D’Aria
03 June 2022
Pembrolizumab for the early stages
“With the KEYNOTE-716 study – continues Ascierto – an important milestone has been reached because it has been shown that adjuvant immunotherapy with pembrolizumab for one year is also able to improve distant metastasis-free survival, a surrogate parameter of overall survival. “. Indeed, the goal of such early stage therapies is to increase healing rates. For early melanoma, pembrolizumab is currently approved in the US for patients (12 years of age and older) with fully resected stage IIB, IIC and III melanoma. As for Europe, just last May the CHMP (Committee for Medicinal Products for Human Use) of the European Medicines Agency issued a positive opinion for the marketing, based on the results of the KEYNOTE-716 study. The data will now be shared with other health authorities globally.
Melanoma, early stage immunotherapy also works in the real world
September 20, 2021
“These new data are encouraging to the melanoma community and add to the positive results of other studies of pembrolizumab in the early stages of the disease,” concludes Scot Ebbinghaus, Vice President, global clinical development, Merck Research Laboratories. small cell in stage IB and IIIA, in stage III melanoma, in renal cell carcinoma, in triple negative breast cancer and in high-risk invasive non-muscle bladder cancer ”.