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Vaccine shows promise in patients with metastatic melanoma

Issue: December 25, 2012

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

In the phase 1/2 open-label clinical trial, researchers in Havana, studied 35 patients (mean age, 54.23 years) with metastatic cutaneous melanoma who were treated subcutaneously with N-glycolyl GMC (NGcGMC)/very–small-size proteoliposomes vaccine. The primary objective was choosing the optimal biological dose of the vaccine based on immunogenicity, efficacy and safety results.

The researchers administered five doses every 2 weeks, then monthly until 15 doses were administered, at six dose levels. Five groups of patients (n=5 per group) were assigned to 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. Researchers also measured antitumor effect and safety.

Patients received a combined 338 immunizations, and 38.25% of patients received complete treatment.

Twenty-one patients (61.75%) discontinued treatment due to schedule noncompliance, patient decision, death or worsening of performance status. 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 IgG antibody responses. Researchers reported that 38.46% of patients who achieved disease control. Five experienced complete or partial response and five achieved stable 
disease.

Patients in the 900-mcg cohort had the best responses, with two patients achieving complete response.

Twenty-eight patients were evaluated for OS, with global OS of 20.4 months. Patients in the 600-mcg cohort demonstrated the longest OS (20.2 months), followed by patients in the 900-mcg cohort (19.4 months). At analysis, however, no patients in the 600-mcg cohort were alive, while 30% of patients in 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.”

Reference:

Osorio M. Cancer Manag Res. 2012;4:341-345.