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Checkpoint Therapeutics Announces Cosibelimab Longer-Term Results in Advanced Cutaneous Squamous Cell Carcinoma Presented at ESMO Congress 2024
WALTHAM, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the presentation of longer-term data from its pivotal trial of cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, in locally advanced and metastatic cutaneous squamous cell carcinoma ("cSCC") during the European Society for Medical Oncology ("ESMO") Congress 2024, which is taking place in Barcelona, Spain, from September 13 to 17, 2024.
Poster Presentation Title: Cosibelimab in Advanced Cutaneous Squamous Cell Carcinoma (CSCC): Longer-term Efficacy and Safety Results from Pivotal Study
"These longer-term results for cosibelimab presented at the ESMO Congress demonstrate a deepening of response over time, with higher objective response and complete response rates than initially observed at the primary analyses, and continue to expand the evidence supporting the efficacy and safety of cosibelimab as a potential new treatment for advanced cSCC," said James Oliviero, President and Chief Executive Officer of Checkpoint. "We look forward to our upcoming December 28, 2024, Prescription Drug User Fee Act ("PDUFA") goal date for our Biologics License Application for cosibelimab, and believe, if approved, cosibelimab's dual mechanisms of action and safety profile may position the product, over time, as the preferred immunotherapy of U.S. oncologists."
Data highlights include:
Efficacy
With 16 months of additional follow-up since the primary analysis, cosibelimab demonstrated increasing objective response rates ("ORRs") and complete response rates per independent central review in 109 patients with advanced cSCC.
ORRs of 54.8% and 50.0% achieved in locally advanced and metastatic cSCC, with median follow-up durations of 24.1 and 29.3 months, respectively.
Results demonstrate a deepening of response over time, with complete response rates of 25.8% and 12.8% in locally advanced and metastatic cSCC, respectively.
Clinically meaningful durations of response ("DOR") were observed, with median DORs not yet reached in either group.
Safety
Overall, in 192 advanced cSCC patients treated with cosibelimab, a manageable safety profile was observed, with notable low rates of treatment-emergent adverse events ("TEAEs"), severe immune-related adverse events ("irAEs"), and treatment discontinuations.
3.6% of patients experienced an irAE assessed as grade 3, with no observed grade ≥4 irAEs.
No events of grade ≥3 pneumonitis, colitis, hepatitis, nephritis, or endocrinopathies.
Treatment discontinuation due to TEAEs, regardless of attribution, was observed in 12 patients (6.3%); the most common reason was COVID-19/COVID-19 pneumonia (1.6%).
Poster Presentation Title: Cosibelimab in Advanced Cutaneous Squamous Cell Carcinoma (CSCC): Longer-term Efficacy and Safety Results from Pivotal Study
"These longer-term results for cosibelimab presented at the ESMO Congress demonstrate a deepening of response over time, with higher objective response and complete response rates than initially observed at the primary analyses, and continue to expand the evidence supporting the efficacy and safety of cosibelimab as a potential new treatment for advanced cSCC," said James Oliviero, President and Chief Executive Officer of Checkpoint. "We look forward to our upcoming December 28, 2024, Prescription Drug User Fee Act ("PDUFA") goal date for our Biologics License Application for cosibelimab, and believe, if approved, cosibelimab's dual mechanisms of action and safety profile may position the product, over time, as the preferred immunotherapy of U.S. oncologists."
Data highlights include:
Efficacy
With 16 months of additional follow-up since the primary analysis, cosibelimab demonstrated increasing objective response rates ("ORRs") and complete response rates per independent central review in 109 patients with advanced cSCC.
ORRs of 54.8% and 50.0% achieved in locally advanced and metastatic cSCC, with median follow-up durations of 24.1 and 29.3 months, respectively.
Results demonstrate a deepening of response over time, with complete response rates of 25.8% and 12.8% in locally advanced and metastatic cSCC, respectively.
Clinically meaningful durations of response ("DOR") were observed, with median DORs not yet reached in either group.
Safety
Overall, in 192 advanced cSCC patients treated with cosibelimab, a manageable safety profile was observed, with notable low rates of treatment-emergent adverse events ("TEAEs"), severe immune-related adverse events ("irAEs"), and treatment discontinuations.
3.6% of patients experienced an irAE assessed as grade 3, with no observed grade ≥4 irAEs.
No events of grade ≥3 pneumonitis, colitis, hepatitis, nephritis, or endocrinopathies.
Treatment discontinuation due to TEAEs, regardless of attribution, was observed in 12 patients (6.3%); the most common reason was COVID-19/COVID-19 pneumonia (1.6%).
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