UNLOXCYT Approved to Treat Metastatic cSCC

Checkpoint Therapeutics’ UNLOXCYT (cosibelimab-ipdl) has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. It is the first and only programmed death ligand-1 (PD-L1) blocking antibody to receive FDA marketing approval for this indication.

FDA approval for UNLOXCYT was granted based on clinically meaningful objective response rates and duration of response data, as assessed by an independent central review committee, from study CK-301-101 (NCT03212404), a multicenter, multicohort, open-label study of UNLOXCYT in adults with advanced solid tumor cancers, including cSCC.

“Today’s FDA approval of UNLOXCYT — the first marketing approval for our company — is a significant milestone both for Checkpoint and for patients with advanced cSCC,” said James Oliviero, president and chief executive officer at the company. “This approval marks Checkpoint’s transformation to a commercial-stage company, with the opportunity to compete in a U.S. market estimated to exceed $1 billion annually, where we believe UNLOXCYT offers a differentiated treatment option versus available therapies by binding to PD-L1, rather than programmed death receptor-1, to release the inhibitory effects of PD-L1 on the anti-tumor immune response. Additionally, UNLOXCYT has demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity, another potential differentiating feature of the drug compared to existing marketed therapies for patients with cSCC.”