Melanoma Coverage from Every Angle

Phase I Study of Anti–PD-1 Antibody in Advanced Melanoma

By: Sarah Campen, PharmD
Posted: Wednesday, January 30, 2019

According to the results of a first-in-human dose-escalation study, the anti–PD-1 monoclonal antibody JS001 appears to have clinical activity in patients with advanced melanoma or urologic cancer who are refractory to standard systemic therapy. Participants with an immune-active profile in the tumor microenvironment or in peripheral blood responded to JS001, based on the phase I trial results published in the Journal of Hematology & Oncology.

“JS001 was well tolerated and demonstrated promising antitumor activity in [urothelial carcinoma] and [renal cell carcinoma] as well as in previously underexplored acral and mucosal melanoma subtypes,” stated Bixia Tang, MD, of the Peking University Cancer Hospital & Institute in Beijing, China, and colleagues.

A total of 36 patients received a single-dose, intravenous infusion of JS001 followed by multiple dose infusions every 2 weeks. Participants had advanced melanoma (n = 22) or urologic cancer (n = 14). Of the patients with melanoma, 14 had an acral subtype and 4 had a mucosal subtype, neither of which were associated with chronic exposure to ultraviolet light.

A complete response was reported in 1 patient, partial responses were observed in 7 patients, and 10 patients had stable disease. The objective response rate was 22.2%, and the disease control rate was 50.0%. The researchers found that clinical responses correlated with several factors, including PD-L1 expression on tumor cells, the presence of tumor-infiltrating lymphocytes, baseline tumor volume, and a high percentage of activated CD8-positive T cells.

As for safety, JS001 was reported to be well tolerated, and no dose-limiting toxicity was observed. Grade 3 or 4 treatment-related adverse events occurred in 36% of patients.

Disclosure: The study authors reported no conflicts of interest.

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.