Cosibelimab BLA Resubmitted to FDA for Metastatic cSCC

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The manufacturer has resubmitted an application to the FDA for approval of the drug cosibelimab, which is being investigated for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma.

Cutaneous squamous cell carcinoma - Generated with Google Gemini AI

Cutaneous squamous cell carcinoma - Generated with Google Gemini AI

  • The biologics license application (BLA) of cosibelimab (formerly CK-301) for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) has been resubmitted to the FDA.
  • The FDA issued a complete response letter (CRL) to the application in December 2023.
  • The CRL was in response to inspection findings at the drug’s manufacturing facility.

The BLA of cosibelimab, an anti-PD-L1 antibody, for the treatment of metastatic or locally advanced cSCC that is not eligible for curative surgery or radiation has been resubmitted to the FDA following a CRL that was issued in December 2023, according to Checkpoint Therapeutics.1

The CRL was issued following a multisponsor inspection of the third-party manufacturing organization and cited “approvability issues” to be addressed in the BLA resubmission; however, there were no concerns presented regarding the clinical data package, safety, or labeling of the drug.1,2

Findings from Study CK-301-101 (NCT03212404) support the BLA.3 Data from the phase 1 study were published in October 2023 in the Journal for ImmunoTherapy of Cancer and showed an objective response rate (ORR) of 47.4% (95% CI, 36.0%-59.1%) at a median follow-up of 15.4 months (range, 0.4-40.5).4 The median duration of response was not reached (range, 1.4+ to 34.1+ months), and an ongoing response was reported in 73% of patients.

The most common treatment-emergent adverse events (AEs) occurring in at least 15% of patients were fatigue (26.9%), rash (16.7%), and anemia (15.4%). Immune-related AEs were reported in 23.1% of patients, with 2.6% reporting grade 3 immune-related AEs. No grade 4 or 5 immune-related AEs were observed, and no treatment-related deaths were reported.

“From a safety profile perspective, both a scientifically plausible rationale and reasonable evidence from published clinical data support the premise that certain serious toxicities known to occur with available anti-PD-1 antibodies can be avoided with the anti-PD-L1 antibody cosibelimab, possibly owing to the presence of the other PD-1 ligand, PD-L2, which may maintain some level of checkpoint signaling,” study authors wrote.

In July 2023, Checkpoint Therapeutics announced longer-term data showing that cosibelimab had a deepened response over time, with a 55% ORR and 26% complete response (CR) rate in locally advanced cSCC and a 50% ORR and 13% CR rate in metastatic cSCC.1

REFERENCES:
1. Checkpoint Therapeutics announces biologics license application resubmission for cosibelimab. News release. Checkpoint Therapeutics. July 2, 2024. Accessed July 2, 2024. https://tinyurl.com/4a2aej3r
2. US Food and Drug Administration issues complete response letter for cosibelimab solely due to inspection findings at third-party manufacturer. News release. Checkpoint Therapeutics, Inc. December 18, 2023. Accessed July 2, 2024. https://tinyurl.com/5djvexw5
3. US Food and Drug Administration issues complete response letter for cosibelimab solely due to inspection findings at third-party manufacturer. News release. Checkpoint Therapeutics, Inc. December 18, 2023. Accessed July 2, 2024. https://tinyurl.com/5djvexw5
4. Clingan P, Ladwa R, Brungs D, et al.Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma. J Immunother Cancer. 2023;11(10):e007637. doi:10.1136/jitc-2023-007637
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