Toripalimab is similarly effective but safer than high-dose interferon-α2b (HDI) for patients with resected mucosal melanoma, according to research published in Annals of Oncology.

Recurrence-free survival (RFS), distant metastasis-free survival, and overall survival outcomes were similar between the treatment arms. However, the rate of severe treatment-related adverse events (AEs) was nearly 8 times higher with HDI.

In this phase 2 study ( Identifier: NCT03178123), researchers randomly assigned 145 patients with resected mucosal melanoma to toripalimab (n=73) or HDI (n=72). Baseline characteristics were similar between the treatment arms, and roughly half of patients in each arm had PD-L1-positive tumors.

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The patients were treated for 1 year or until disease relapse/distant metastasis, unacceptable toxicity, or withdrawal of consent. The primary endpoint was RFS.

At a median follow-up of 26.3 months, the median RFS was 13.6 months in the toripalimab arm and 13.9 months in the HDI arm (hazard ratio [HR], 1.053; 95% CI, 0.690-1.607).

The median overall survival was not reached in the HDI arm and was 35.1 months in the toripalimab arm (HR, 1.107; 95% CI, 0.664-1.844). The median distant metastasis-free survival was 14.6 months and 16.3 months, respectively (HR, 1.002; 95% CI, 0.653-1.537).

As in the overall cohort, efficacy outcomes were not significantly different between the treatment arms for patients with PD-L1-positive tumors. 

The rate of grade 3 or higher treatment-related AEs was higher in the HDI arm than in the toripalimab arm — 84.7% and 11%, respectively. 

The most common treatment-emergent AE in the HDI arm was myelosuppression (98.6%), and the most common treatment-emergent AE in the toripalimab arm was an elevated thyroid-stimulating hormone level (49.3%). 

“Toripalimab showed a similar RFS and a more favorable safety profile than HDI, both better than historical data, suggesting that toripalimab might be the better treatment option,” the researchers wrote. “However, additional translational studies and better treatment regimens are still warranted to improve the clinical outcome of MM [mucosal melanoma].”

Disclosures: This study was supported by Shanghai Junshi Bioscience Co., Ltd. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Lian B, Si , Chi Z, et al. Toripalimab (anti-PD-1) versus high-dose interferon-α2b as adjuvant therapy in resected mucosal melanoma: A phase II randomized trial. Ann Oncol. Published online July 13, 2022. doi:10.1016/j.annonc.2022.07.002.