- The FDA has placed a partial clinical hold on Alpine Immune Sciences Inc's (NASDAQ:ALPN) NEON-2 trial evaluating davoceticept (ALPN-202) in combination with pembrolizumab in adults with advanced malignancies.
- The partial clinical hold was prompted by Alpine's report of patient death in the NEON-2 trial.
- The participant had choroidal melanoma previously treated with nivolumab and ipilimumab and had received a single dose each of davoceticept and pembrolizumab.
- The treating physicians considered the participant's death to be attributed to cardiogenic shock as likely related to immune-mediated myocarditis or possibly infection.
- In June, Alpine announced a clinical trial collaboration and supply agreement with Merck & Co Inc (NYSE:MRK) to evaluate ALPN-202 in combination with Merck's Keytruda (pembrolizumab).
- Patients enrolled in the NEON-2 trial may continue to receive davoceticept and pembrolizumab, although no additional patients may be enrolled until the partial clinical hold is resolved.
- The partial clinical hold does not affect the ongoing NEON-1 clinical trial of davoceticept as monotherapy.
- Price Action: ALPN shares are down 13.20% at $6.65 during the market session on the last check Monday.
