Retifanlimab-dlwr (Zynyz), an intravenous programmed death receptor–1 (PD-1) inhibitor, for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.
MCC is a rare and aggressive skin cancer with a high rate of metastatic disease and an estimated 5-year overall survival of just 14% among those who present with metastatic disease.
Incidence is rapidly increasing in the US, particularly among adults older than 65 years, Incyte noted.
More than a third of patients with MCC present with regional or distant metastases, which are associated with high rates of mortality.
POD1UM-201 was an open-label, single-arm, phase 2 study that evaluated the agent in 65 systemic treatment–naive adults with metastatic or recurrent locally advanced MCC.