Camrelizumab plus apatinib and temozolomide delivers in advanced acral melanoma

The combination of camrelizumab plus apatinib and temozolomide appears to be beneficial in the first-line treatment of advanced acral melanoma, with the majority of the patients showing response and an acceptable safety profile, according to the results of a phase II study.

The single-arm, single-centre, phase II study included 50 patients (median age 57 years, 64 percent men) with treatment-naïve unresectable stage III or IV acral melanoma. These patients received 4-week cycles of intravenous camrelizumab (given at 200 mg, every 2 weeks), oral apatinib (given at 250 mg, once daily), and intravenous temozolomide (given at 200 mg/m², once daily on days 1 to 5) until disease progression or unacceptable toxic effects.

The primary endpoint was objective response rate (ORR) as evaluated by investigators according to the Response Evaluation Criteria In Solid Tumors. Secondary endpoints included progression-free survival (PFS), time to response, duration of response, disease control rate (DCR), overall survival (OS), and safety.

Over a median follow-up of 13.4 months, 32 out of 50 patients responded to treatment. The corresponding ORR was 64.0 percent (95 percent confidence interval [CI], 49.2–77.1). The median time to response was 2.7 months, while the duration of response was 17.5 months (95 percent CI, 12.0 to not reached).

DCR was 88.0 percent (95 percent CI, 75.7–95.5), and the estimated median PFS was 18.4 months (95 percent CI, 10.6 to not reached). Meanwhile, the median OS was not reached.

The combination had an acceptable safety profile. The most frequent grade 3 or 4 treatment-related adverse events were increased gamma-glutamyltransferase levels (30 percent), reduced neutrophil count (22 percent), elevated conjugated bilirubin levels (20 percent), and increased aspartate aminotransferase levels (20 percent). No treatment-related deaths occurred.