BLA for Cosibelimab Submitted to FDA for Management of Metastatic/Advanced Cutaneous SCC


The biologic license application for cosibelimab for patients with metastatic or locally advanced cutaneous squamous cell carcinoma is supported by findings from a phase 1 study.

A biologic license application has been submitted to the FDA for the investigational anti–PD-L1 antibody cosibelimab (CK-301) as a treatment for patients with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC not suitable for curative surgery or radiation, according to a press release from Checkpoint Therapeutics.

The submission of the biologic license application was supported by positive efficacy and safety findings from an ongoing open-label, multi-regional, multicohort phase 1 clinical trial (NCT03212404) evaluating cosibelimab in patients with selected recurrent or metastatic cancers.

Trial investigators reported that cosibelimab had achieved the study’s primary end point in the cohort of patients with metastatic cSCC; the agent yielded a confirmed objective response rate (ORR) of 47.4% (95% CI, 36.0%-59.1%) by independent central review among 78 evaluable patients per RECIST v1.1 criteria. Additionally, investigators reported that the agent produced a confirmed ORR of 54.8% (95% CI, 36.0%-72.7%) per independent central review of 31 patients with locally advanced cSCC.

“Based on its compelling and differentiated product profile and the positive data generated to date, we believe cosibelimab has the potential to be an important treatment option for patients,” James Oliviero, president and chief executive officer of Checkpoint, said in the press release.

Cosibelimab is a fully human monoclonal antibody that directly binds to PD-L1 and blocks its interactions with receptors PD-1 and B7.1. By inhibiting this interaction, the suppressive effects of PD-L1 on anti-tumor CD8-positive T-cells to restore cytotoxic T cell responses is removed.

Investigators of the multicohort phase 1 clinical trial are evaluating the efficacy and safety of cosibelimab in multiple types of cancer including cSCC, lung neoplasms, advanced malignant mesothelioma, head and neck cancer, and melanoma. Patients received cosibelimab at fixed doses of either 800 mg every 2 weeks or 1200 mg every 3 weeks.

Primary end points of the trial included dose limiting toxicities and treatment-emergent adverse effects (AEs) per National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) v4.03 criteria. Secondary end points included confirmed best overall responses, duration of response, overall survival, and the pharmacokinetics of cosibelimab.

Patients 18 years and older with a histologically confirmed diagnosis of unresectable or metastatic cSCC not amenable to local therapy were eligible to enroll on the trial. Additional inclusion criteria included having an ECOG performance status of 0 or 1; an estimated life expectancy of at least 3 months; at least 1 measurable lesion per RECIST v1.1 criteria; adequate hematological, hepatic, and renal function; and providing a formalin fixed tumor tissue sample from a biopsy of a tumor lesion.

Patients were unable to enroll on the trial if they had received prior therapy with an anti–PD-1, anti–PD-L1, anti–PD-L2, anti–CD137, anti–CTLA04 agent, or any other antibody specifically targeting T-cell stimulation pathways. Patients were also unsuitable for enrollment if they had a history of severe hypersensitivity reaction to other monoclonal antibodies, received anticancer therapy within 4 weeks prior to beginning study treatment, had significant acute or chronic infections, active or previous interstitial lung disease, or active or suspected autoimmune disease.


Checkpoint Therapeutics submits biologics license application to FDA for cosibelimab as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma. News release. Checkpoint Therapeutics. January 4, 2023. Accessed January 5, 2023.

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