Systemic therapy for Asian patients with advanced <scp>BRAF V600</scp>‐mutant melanoma in a real‐world setting: A multi‐center retrospective study in Japan (<scp>B‐CHECK‐RWD</scp> study)

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Immune checkpoint inhibitors have been shown to prolong survival of patients with several types of cancer, and the finding was first established in melanoma. Previously, systemic therapy for advanced melanoma aimed only at tumor control and palliation of symptoms. However, in recent years, some patients who received systemic therapy have achieved a complete response and survived without continuous treatment for more than several years. This review discusses the long‐term survival rates achieved with currently used systemic therapies and their future perspectives. Long‐term survival is currently most likely to be achieved with the use of the standard‐dose combination of nivolumab plus ipilimumab, however, this regimen is associated with a high frequency of serious or persistent immune‐related adverse events. Several new anti‐PD‐1‐based combination therapies with a better risk–benefit balance are currently under development. Although the acral and mucosal subtypes tend to be less responsive to immune checkpoint inhibitors, anti‐PD‐1‐based combination therapy should continue to be investigated for these subtypes owing to its potential for better long‐term survival. With the development of efficacious immunotherapy and targeted therapy, it is important to determine the optimal duration of systemic therapy to avoid unnecessary health and financial burdens as well as to improve efforts to support long‐term cancer survivors. As the goal of systemic therapy shifts from tumor control to long‐term survival, in future clinical trials, long‐term clinical outcomes should be evaluated to assess the benefits of novel agents.

Section: Combination Immunotherapysupporting

confidence: 82%

Section: Long‐term Outcomes Of Immunotherapy and Targeted Therapysupporting

confidence: 82%

Long‐term survival with systemic therapy in the last decade: Can melanoma be cured?

Namikawa,

Nakano,

Ogata

et al. 2024

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“…In a retrospective observational study of 336 BRAF-mutated melanomas in Japan, 236 patients were treated with BRAF/MEKi, 64 with anti-PD-1 Ab, and 36 with niv/ipi as first-line therapy. 85 With a median follow-up of 19.9 months, ORR was significantly higher for BRAF/MEKi (69% for BRAF/MEKi, 27% for anti-PD-1…”

Section: (N = 36mentioning

confidence: 94%

“…In a retrospective observational study of 336 BRAF‐mutated melanomas in Japan, 236 patients were treated with BRAF/MEKi, 64 with anti‐PD‐1 Ab, and 36 with niv/ipi as first‐line therapy 85 . With a median follow‐up of 19.9 months, ORR was significantly higher for BRAF/MEKi (69% for BRAF/MEKi, 27% for anti‐PD‐1 Ab, and 28% for niv/ipi); median PFS was also significantly prolonged for BRAF/MEKi (14.7 months for BRAF/MEKi, 5.4 months for anti‐PD‐1 Ab, and 5.8 months for niv/ipi).…”

Section: Development Status Of Melanoma Treatment In Japanmentioning

confidence: 99%

Optimal strategy in managing advanced melanoma

Uchi

2023

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The advent of immune checkpoint inhibitors and combination therapy with BRAF inhibitors and MEK inhibitors has dramatically improved the prognosis of advanced melanoma. However, since acral melanoma and mucosal melanoma, which are rare in Western countries but are major subtypes of melanoma in East Asia, including Japan, have a low frequency of BRAF mutations, there are currently no treatment options other than immune checkpoint inhibitors in most such cases. Furthermore, owing to a lower tumor mutation burden, immune checkpoint inhibitors are less effective in acral and mucosal melanoma than in cutaneous melanoma. The aim of this review was to summarize the current status and future prospects for the treatment of advanced melanoma, comparing cutaneous melanoma, acral melanoma, and mucosal melanoma.

“…Adopted from Rigo et al 17 checkpoint inhibitors. In Japan, it has been reported that BRAF/ MEK inhibitors are equally effective as advanced-stage treatment compared to Western countries, 20,21 while immune checkpoint inhibitors are less effective. [22][23][24] The efficacy and safety profiles of anti-PD-1 monotherapy in the adjuvant setting in an Asian population, including a high ratio of acral melanoma, have been reported.…”

Section: Re Al World E Viden Ce Rel Aps E-free Survival and Over All ...mentioning

confidence: 99%

Deciphering the role of adjuvant therapy in melanoma and its actual benefits

Fukushima,

Miyashita,

Kimura

et al. 2024

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Numerous clinical trials have demonstrated a significant improvement in recurrence‐free survival among melanoma patients receiving high‐dose interferon‐α, immune checkpoint inhibitors (pembrolizumab, nivolumab), and BRAF/MEK inhibitors (dabrafenib‐trametinib). This study aimed to investigate whether these findings hold true in real‐world conditions for patients with stage III and IV melanoma. In particular, the study explores the efficacy and side effects of adjuvant therapies, focusing on anti‐PD‐1 antibodies and BRAF/MEK inhibitors. While clinical trials have shown comparable efficacy, differences in side‐effect profiles, especially the persistence of immune‐related adverse events with anti‐PD‐1 antibodies, highlight the need for careful consideration in adjuvant settings. In the absence of established biomarkers for guiding adjuvant therapy decisions, it becomes imperative to transparently communicate the advantages and disadvantages of drug administration to patients. The study also delved into the impact of melanoma subtype and BRAF mutation status on the effectiveness of adjuvant therapy, emphasizing the need for further investigation.