- 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.
- Shares are up 10% premarket on fairly good volume.