Journal Article

Efficacy and safety of PD‐1 monoclonal antibody combined with interferon‐alpha 1b and anlotinib hydrochloride as the second‐line therapy in patients with unresectable advanced melanoma: A retrospective study

Zhang, Mengyu, Zou, Daopei, Tang, Jingyi, Shi, Qiong, Li, Chunying, Gao, Tianwen, Zhu, Guannan, Zhao, Bolun, Liu, Fang

2024

Overview

Background Immune‐checkpoint inhibitors are now used more commonly in combination than monotherapy as the first‐line choice in patients with unresectable advanced melanoma. Nevertheless, for cases that progressed after the initial combination therapy, the subsequent regimen option can be very difficult. Herein, we reported the efficacy and safety of a triple combination regimen in Chinese unresectable advanced melanoma patients who had poor responses to the first‐line immune therapy. Methods We reviewed the clinical profiles of patients diagnosed with stage IIIC‐IV melanoma between June 1, 2020, and September 30, 2023. The patients who failed the prior immune therapies and received anti‐PD‐1 mono antibody plus interferon(IFN)‐alpha 1b and anlotinib hydrochloride as the second‐line therapy were enrolled in the retrospective analysis. Additionally, we examined the exhaustion of T‐cells using mIHC staining in available tumor samples. Results Fifty‐five patients were included in this study. The median follow‐up period was 13.6 months. The objective response rate evaluated by the investigators was 9.1%(1CR, 4PR). The disease control rate was 47.3%. The median overall survival was 17.6 months, and the median progression‐free survival was 2.8 months. The adverse events rate of any grade was 100%. Grade 3 or 4 irAEs were observed in 29.1% of cases. Multiplex immunohistochemical staining revealed an increased trend of TIM3 expression on tumor‐infiltrating T cells in patients without objective response. Conclusion PD‐1 monoclonal antibody plus interferon‐alpha 1b plus anlotinib showed acceptable tolerability and anticancer benefits in Chinese metastatic melanoma patients as a second‐line therapy.

• Publisher: John Wiley & Sons, Inc,John Wiley and Sons Inc,Wiley
• Subject: Adult / advanced melanoma / Aged / anlotinib / Antibodies / Antineoplastic Combined Chemotherapy Protocols - adverse effects / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Disease control / FDA approval / Female / Females / Growth factors / Humans / IFN‐α1b / Immune checkpoint inhibitors / Immune Checkpoint Inhibitors - administration & dosage / Immune Checkpoint Inhibitors - adverse effects / Immune Checkpoint Inhibitors - therapeutic use / Indoles - administration & dosage / Indoles - adverse effects / Indoles - therapeutic use / Interferon / Interferon-alpha - administration & dosage / Interferon-alpha - therapeutic use / Kinases / Lymphocytes T / Male / Melanoma / Melanoma - drug therapy / Melanoma - mortality / Melanoma - pathology / Metastases / Middle Aged / Monoclonal antibodies / Mutation / Neoplasm Staging / Patients / PD‐1 / Programmed Cell Death 1 Receptor - antagonists & inhibitors / Quinolines - administration & dosage / Quinolines - adverse effects / Quinolines - therapeutic use / Regression analysis / Response rates / Retrospective Studies / second‐line therapy / Software / Survival analysis / Toxicity / Treatment Outcome / Tumors / Variables