Professor Jean-François Baurain is pleased to provide a summary and analysis of the presentations from the mini-oral session on melanomas at ESMO2023.
The SECOMBIT trial assessed the efficacy of immunotherapy in comparison to targeted therapy alone in metastatic melanoma. The five-year follow-up data confirms that immunotherapy significantly improves both total Progression-Free Survival (PFS) and Overall Survival (OS). The observed nearly 10% difference in OS is not only statistically significant but also clinically meaningful. Notably, immunotherapy demonstrates superior efficacy in preventing the onset of brain metastasis, a complication occurring in approximately 20% of patients.
The 7-year update of the NIBIT-M2 trial reaffirmed the superiority of double immunotherapy over classical chemotherapy or monotherapy. Response and survival rates remain consistent with the results observed at the 5-year follow-up. These findings emphasize that the combination of ipilimumab and nivolumab should be the first-line treatment for metastatic melanoma patients with untreated, asymptomatic brain metastasis.
The question persists regarding the management of tumors showing poor response to immunotherapy, such as uveal melanoma. Encouraging results were presented for tebentafusp in metastatic uveal melanoma. This phase 3 trial demonstrated a survival benefit after 3 years of follow-up with tebentafusp. These results have been recently published in the New England Journal of Medicine.
In a specific subgroup of advanced mucosal melanoma patients, approximately 50% exhibited improved responses due to the effects of lifileucel. This treatment induced clinically meaningful antitumor activity characterized by durable responses. Lifileucel, although second-line and preceded by aggressive chemotherapy, could be a promising option for patients with poor responses to checkpoint inhibition therapies.
Furthermore, a phase 2 study utilizing cemiplimab in a neoadjuvant setting for Cutaneous Squamous Cell Carcinoma (CSCC) demonstrated a 50% pathological complete response rate. The one-year follow-up data presented here revealed that almost none of these patients experienced relapse, even though 60% did not receive any adjuvant treatment. This suggests that neoadjuvant therapy holds great promise in various cancers. In the case of CSCC, it may potentially eliminate the need for adjuvant therapy, although further data are required to confirm these findings.