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Immunotherapy for Melanoma Demonstrates Clinical Efficacy in Phase II Trial

Genetically modified melanoma cells elicit immune response

Promising data have been reported from a phase II clinical study of dorgenmeltucel-L HyperAcute immunotherapy (NewLink Genetics Corp.) in combination with pegylated interferon (pegIFN)-alpha 2b in patients with advanced metastatic, progressive, refractory, or recurrent melanoma.

The study will be featured in the Summer 2014 edition of the Ochsner Journal.

The treatment regimen consisted of 12 weekly vaccinations with dorgenmeltucel-L (150 million cells) in combination with short-course pegIFN-alpha 2b administered during weeks 5 through 12. The data demonstrated that the combination was capable of inducing complete and durable clinical responses, with tumor regression and immune activation. The study enrolled 25 melanoma patients. Of these patients, 21 completed the trial and were evaluable for response.

Of 16 patients with stage IV disease, two showed a complete response (CR), as determined by Response Evaluation Criteria in Solid Tumors (RESIST); one had stable disease (SD); and four had no evidence of disease (NED) after resection. Further, of nine patients with stage II/III disease, three remained NED, and one stage-IIC patient had slow progressive disease (PD) with a single site resected; this patient is currently NED. The median overall survival period was 29 months, with 60% of the patients surviving for longer than 1 year.

Of the 25 patients enrolled, 12 (48%) were still alive. All evaluable patients (21/21) seroconverted, developing autoimmune antibodies. Importantly, four of the 25 patients developed vitiligo, correlating with two CR patients by RECIST criteria and two NED patients.

Dorgenmeltucel-L HyperAcute immunotherapy consists of melanoma cell lines that have been genetically modified to express alpha-gal carbohydrates on cell-surface molecules. Alpha-gal has been shown to stimulate an immune response against melanoma-specific antigens in tumor cell lines, thereby enabling the patient’s immune system to target and destroy his or her melanoma cells.

Source: NewLink Genetics; May 30, 2014.

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