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▎WuXi AppTec Content Team Editor On January 25, 2022, Checkpoint Therapeutics announced that the anti-PD-L1 antibody cosibelimab has achieved positive results in a clinical trial that supports registration
.
The trial met its primary endpoint, achieving an objective response rate (ORR) of 47.
4% (95% CI: 36.
0, 59.
1) in patients with metastatic cutaneous squamous cell carcinoma (cSCC) treated with cosibelimab (n=78)
.
The safety and tolerability profile was consistent with previous studies
.
Based on the positive data obtained, Checkpoint plans to submit a Biologics License Application (BLA) to the US FDA by the end of this year
.
Squamous cell carcinoma of the skin is a common type of skin cancer.
Although most cases are local tumors that can be radically removed, there are still many patients with advanced disease that is life-threatening
.
Cosibelimab (formerly CK-301) is a potential "best-in-class", high-affinity IgG1 subtype fully human anti-PD-L1 monoclonal antibody
.
It directly binds PD-L1 and blocks the interaction of PD-L1 with PD-1 and B7.
1 receptors, thereby eliminating the inhibitory effect of PD-L1 against tumor CD8-positive T cells and restoring cytotoxic T cell responses
.
A potential difference between cosibelimab and currently approved anti-PD-1 and PD-L1 antibodies is that it can bind to more than 99% of PD-L1 on the surface of tumor cells, reactivating the anti-tumor immune response
.
Furthermore, it has a functional Fc domain that induces antibody-dependent cell-mediated cytotoxicity (ADCC), which may enhance the potential efficacy of certain tumor types
.
Image source: Checkpoint's official website In addition to meeting the primary endpoint of ORR, at the data cutoff time, the median duration of response (DOR) for patients had not yet been reached
.
The 201 patients with advanced cancer enrolled and treated in all cohorts exhibited a safety profile consistent with previous studies, with most treatment-emergent adverse events reported as grade 1 or 2 in severity
.
Image source: Mr.
James F.
Oliviero, President and CEO of Checkpoint, said: "We are pleased to report top-line results from the pivotal clinical trial of cosibelimab in patients with metastatic cutaneous squamous cell carcinoma
.
The strong ORR results can be attributed to cosibelimab's differential, dual mechanism of action utilizing T cells and natural killer cells,
while
also demonstrating a potentially favorable safety profile for its binding to PD-L1, which is comparable to anti-PD-1 therapy The drug was associated with a lower rate of serious or worse adverse events than the previous study
.
We look forward to presenting the data in detail at an upcoming medical meeting
.
"Reference: [1] Checkpoint Therapeutics Announces Positive Topline Results from the Registration-Enabling Trial of Cosibelimab in Metastatic Cutaneous Squamous Cell Carcinoma.
Retrieved January 25, 2022, from https://ir.
checkpointtx.
com/news-events/press -releases/detail/77/checkpoint-therapeutics-announces-positive-topline-results Disclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the opinions in this article do not represent WuXi AppTec This position does not mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
.
The trial met its primary endpoint, achieving an objective response rate (ORR) of 47.
4% (95% CI: 36.
0, 59.
1) in patients with metastatic cutaneous squamous cell carcinoma (cSCC) treated with cosibelimab (n=78)
.
The safety and tolerability profile was consistent with previous studies
.
Based on the positive data obtained, Checkpoint plans to submit a Biologics License Application (BLA) to the US FDA by the end of this year
.
Squamous cell carcinoma of the skin is a common type of skin cancer.
Although most cases are local tumors that can be radically removed, there are still many patients with advanced disease that is life-threatening
.
Cosibelimab (formerly CK-301) is a potential "best-in-class", high-affinity IgG1 subtype fully human anti-PD-L1 monoclonal antibody
.
It directly binds PD-L1 and blocks the interaction of PD-L1 with PD-1 and B7.
1 receptors, thereby eliminating the inhibitory effect of PD-L1 against tumor CD8-positive T cells and restoring cytotoxic T cell responses
.
A potential difference between cosibelimab and currently approved anti-PD-1 and PD-L1 antibodies is that it can bind to more than 99% of PD-L1 on the surface of tumor cells, reactivating the anti-tumor immune response
.
Furthermore, it has a functional Fc domain that induces antibody-dependent cell-mediated cytotoxicity (ADCC), which may enhance the potential efficacy of certain tumor types
.
Image source: Checkpoint's official website In addition to meeting the primary endpoint of ORR, at the data cutoff time, the median duration of response (DOR) for patients had not yet been reached
.
The 201 patients with advanced cancer enrolled and treated in all cohorts exhibited a safety profile consistent with previous studies, with most treatment-emergent adverse events reported as grade 1 or 2 in severity
.
Image source: Mr.
James F.
Oliviero, President and CEO of Checkpoint, said: "We are pleased to report top-line results from the pivotal clinical trial of cosibelimab in patients with metastatic cutaneous squamous cell carcinoma
.
The strong ORR results can be attributed to cosibelimab's differential, dual mechanism of action utilizing T cells and natural killer cells,
while
also demonstrating a potentially favorable safety profile for its binding to PD-L1, which is comparable to anti-PD-1 therapy The drug was associated with a lower rate of serious or worse adverse events than the previous study
.
We look forward to presenting the data in detail at an upcoming medical meeting
.
"Reference: [1] Checkpoint Therapeutics Announces Positive Topline Results from the Registration-Enabling Trial of Cosibelimab in Metastatic Cutaneous Squamous Cell Carcinoma.
Retrieved January 25, 2022, from https://ir.
checkpointtx.
com/news-events/press -releases/detail/77/checkpoint-therapeutics-announces-positive-topline-results Disclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the opinions in this article do not represent WuXi AppTec This position does not mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.