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Vaccine safe, effective in patients with metastatic melanoma

A vaccine based on N-glycolyl GMC gangliosides was safe, immunogenic and displayed efficacy in patients with metastatic melanoma, according to study results.

In a phase 1/2 open-label clinical trial, researchers in Havana, Cuba, studied 35 patients (mean age, 54.23 years) with metastatic cutaneous melanoma being treated subcutaneously with N-glycolyl GMC (NGcGMC)/very–small-size proteoliposomes vaccine. Primary objective was choosing the optimal biological dose of the vaccine based on immunogenicity, efficacy and safety results. Five doses were administered every 2 weeks, then monthly until 15 doses were administered, at six dose levels. Five groups of patients (n=5 per group) were assigned 150 mcg, 300 mcg, 600 mcg, 1,200 mcg or 1,500 mcg, while one group (n=10) received 900 mcg. Antibody titers generated after vaccination were used to determine immunogenicity. Antitumor effect and safety also were measured.

Patients received a combined 338 immunizations; complete treatment was received by 38.25% of patients. Twenty-one patients (61.75%) discontinued treatment (schedule noncompliance, patient decision, death, worsening of performance status), although none withdrew because of vaccine complications. All vaccine dose levels were safe and immunogenic; vaccine-related adverse events included mild to moderate injection site reactions and flu-like symptoms. All patients had specific anti-NeuGcGM3 immunoglobulin M and immunoglobulinG antibody responses. There were 38.46% of patients who achieved disease control, five experienced complete or partial response and five achieved stable disease. The 900-mcg cohort had the best responses, with two patients achieving complete response. Twenty-eight patients were evaluated for overall survival, with global overall survival of 20.40 months. The 600-mcg cohort had best overall survival duration (20.2 months), followed by 900-mcg cohort (19.4 months). At analysis, however, no patients in the 600-mcg cohort were alive, while 30% of the 900-mcg group were alive.

“The biological optimal dose was selected based on all results, particularly immunogenicity and survival data,” the researchers said. “The … optimal dose by the subcutaneous route was 900 mcg.”