Core Insights - Checkpoint Therapeutics presented longer-term data for cosibelimab, an anti-PD-L1 antibody, at the ESMO Congress 2024, indicating improved efficacy and safety for treating advanced cutaneous squamous cell carcinoma (cSCC) [1][2] Efficacy - Cosibelimab showed increasing objective response rates (ORRs) of 54.8% and 50.0% in locally advanced and metastatic cSCC, respectively, with median follow-up durations of 24.1 and 29.3 months [3] - Complete response rates were reported at 25.8% for locally advanced and 12.8% for metastatic cSCC, demonstrating a deepening of response over time [3] - Clinically meaningful durations of response (DOR) were observed, with median DORs not yet reached in either patient group [3] Safety - A manageable safety profile was noted in 192 advanced cSCC patients treated with cosibelimab, with low rates of treatment-emergent adverse events (TEAEs) and severe immune-related adverse events (irAEs) [4] - Only 3.6% of patients experienced grade 3 irAEs, with no grade ≥4 irAEs reported [4] - Treatment discontinuation due to TEAEs occurred in 6.3% of patients, primarily due to COVID-19-related issues [4] Regulatory Status - The FDA issued a complete response letter (CRL) for the cosibelimab Biologics License Application (BLA) in December 2023, citing issues from a third-party contract manufacturing organization inspection [6] - Checkpoint completed a resubmission of the BLA in July 2024, which was accepted by the FDA, with a PDUFA goal date set for December 28, 2024 [6] Industry Context - Cutaneous Squamous Cell Carcinoma (cSCC) is the second most common skin cancer in the U.S., with an estimated annual incidence of approximately 1.8 million cases [7] - About 40,000 cases of cSCC progress to advanced stages, leading to approximately 15,000 deaths annually [8] - The immune-suppressed population presents a challenging target for treatment due to more aggressive disease and higher risks of immune-related toxicities [8] Product Information - Cosibelimab is a fully-human monoclonal antibody that blocks PD-L1 interaction with PD-1 and B7.1 receptors, potentially offering enhanced efficacy through sustained tumor target occupancy and antibody-dependent cellular cytotoxicity (ADCC) [9] - Checkpoint Therapeutics is also developing olafertinib, a third-generation EGFR inhibitor for non-small cell lung cancer [10]
Checkpoint Therapeutics Announces Cosibelimab Longer-Term Results in Advanced Cutaneous Squamous Cell Carcinoma Presented at ESMO Congress 2024