Efficacy comparison between anti-PD-1 antibody monotherapy and anti-PD-1 plus anti-CTLA-4 combination therapy as first-line immunotherapy for advanced acral melanoma: A retrospective, multicenter study of 254 Japanese patients.

BACKGROUND

Although anti-PD-1 antibody monotherapy (PD-1) is commonly used to treat advanced acral melanoma (AM), its efficacy is limited. Further, data on the efficacy of PD-1 plus anti-CTLA-4 antibody (PD-1+CTLA-4) for the treatment of AM are limited. Therefore, we compared the efficacy of PD-1+CTLA-4 and PD-1 in the treatment of Japanese patients with advanced AM.

METHODS

This retrospective study evaluated patients with advanced AM who were treated with PD-1 or PD-1+CTLA-4 as first-line immunotherapy in 24 Japanese institutions between 2014 and 2020. Treatment efficacy focussing on the objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) was compared between the two groups.

RESULTS

In total, 254 patients (palm and sole melanoma [PSM], n = 180; nail apparatus melanoma [NAM], n = 74) were included. Among the patients with PSM, the ORR (19% vs. 31%; P = 0.44), PFS (5.9 vs. 3.2 months; P = 0.74), and OS (23.1 vs. not reached; P = 0.55) did not differ significantly between the PD-1 and PD-1+CTLA-4 groups. Among the patients with NAM, the ORR (61% vs. 10%; P < 0.001) was significantly higher and PFS was longer (6.4 vs. 3.8 months; P = 0.10) in the PD-1+CTLA-4 group than in the PD-1 group. Cox multivariate analysis demonstrated that PD-1+CTLA-4 is an independent predictor of a favourable PFS in patients with NAM (P = 0.002).

CONCLUSIONS

The efficacy of PD-1+CTLA-4 is not superior to that of PD-1 for the treatment of advanced PSM. However, PD-1+CTLA-4 may be more efficacious than PD-1 for the treatment of advanced NAM.

Informations de copyright

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Déclaration de conflit d'intérêts

Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Yasuhiro Nakamura has served as a consultant and/or received honoraria from Merck Sharp & Dohme (MSD), Novartis, Bristol-Myers Squibb (BMS), Maruho, Ono Pharma, Taisho Toyama, and Taiho Pharma. Kenjiro Namikawa has served as a consultant and/or received honoraria from BMS, MSD, Novartis, and Ono Pharma. Yukiko Kiniwa has received honoraria from Novartis and Ono Pharma. Hiroshi Kato has received honoraria from Novartis and Ono Pharma. Osamu Yamasaki has received research funding and/or honoraria from Ono Pharma. Shusuke Yoshikawa has received honoraria from Novartis and Ono Pharma. Takeo Maekawa has received honoraria from BMS, MSD, Novartis, and Ono Pharma. Shigeto Matsushita has received honoraria from BMS, MSD, Novartis, and Ono Pharma. Tatsuya Takenouchi has received honoraria from BMS, MSD, Novartis, and Ono Pharma. Takashi Inozume has received honoraria from BMS, MSD, and Ono Pharma. Satoshi Fukushima has received research funding from Ono Pharma. Shintaro Saito has received honoraria from Ono Pharma. Atsushi Otsuka has served as a consultant and/or received honoraria from BMS, MSD, Novartis, and Ono Pharma, and has received research funding from Eisai. Noriki Fujimoto has received honoraria from Novartis and Ono Pharma. Taiki Isei has served as a consultant and/or received honoraria from Ono Pharma, Pfizer, BMS, and Novartis. Yoshiyasu Umeda has received honoraria from Ono Pharma and Novartis. Naoya Yamazaki has received research funding from Bristol-Myers Squibb, MSD, Novartis, Ono Pharma, and Takara Bio, and has served as a consultant and/or received honoraria from BMS, MSD, Novartis, and Ono Pharma. The other authors have no conflicts of interest to disclose.