Alpine Immune Sciences Inc ALPN:NASDAQ

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Alpine Says FDA Places Partial Clinical Hold on Study of Davoceticept Drug Cocktail in Advanced Malignancies

9:48AM ET 3/07/2022 MT Newswires
Alpine Immune Sciences (ALPN) said Monday the US Food and Drug Administration placed its clinical study of davoceticept in combination with pembrolizumab in patients with advanced malignancies on partial clinical hold following a patient's death.

Under the partial clinical hold, the study will stop enrolling new patients but existing patients may continue to receive the drug combination.

The patient had choroidal melanoma previously treated with nivolumab and ipilimumab, and had received a single dose each of davoceticept and pembrolizumab. The death was attributed to cardiogenic shock, considered by the treating physicians as likely related to immune-mediated myocarditis, or possibly infection.

A separate ongoing trial evaluating davoceticept as a monotherapy is not affected by the partial clinical hold, the company.

Alpine shares were 13.7% lower in morning trading.

Price: 6.51, Change: -1.15, Percent Change: -15.01