Data from a 25-patient Phase 2 clinical trial evaluating NewLink Genetics' (NLNK) dorgenmeltucel-L HyperAcute immunotherapy in combination with pegylated interferon-alpha 2b for advanced metastatic, progressive, refractory or recurrent melanoma shows that the combo is capable of inducing complete and durable clinical responses with tumor regression and immune activation.
Of the sixteen patients with Stage IV disease, two had a complete response as defined by RECIST criteria, one had stable disease and four had no evidence of disease (NED) after resection. Of the 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 is currently NED.
Twelve of the 25 subjects are still alive. All evaluable patients (21/21) seroconverted.
The complete response rate was 12.5% in patients with metastatic disease and the responses were durable.
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