The clinical results of the express dual mechanism PD-L1 monoclonal antibody are positive, and it is expected to submit a regulatory application to the FDA by the end of the year

▎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.
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