About the Trial
Trial Name: Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers
ClinicalTrials.gov ID: NCT03212404
Sponsor: Checkpoint Therapeutics, Inc.
Completion Date (Estimated): December 2024
Spotlight
Clinical Role
Clinical
Supplement Spotlight
CE
Subscribe
News
Article
FDA Approves Cosibelimab-Ipdl for Adult Patients with mCSCC or laCSCC
Author(s):
The indication is for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or radiation.
The FDA approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics, Inc.) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.1 Efficacy and safety results of cosibelimab were demonstrated in the CK-301-101 (NCT03212404) clinical trial.1,2
Image credit: Olivier Le Moal | stock.adobe.com
Some patients experience inadequate responses or severe immune-related adverse events (AEs) when undergoing treatment for mCSCC or laCSCC, indicating the need for improved therapies. Cosibelimab is a programmed death ligand-1 (PD-L1) blocking antibody that activates innate and adaptive immunity by blocking PD-L1 interaction with PD-1 and B7-1 receptors. The agent is an unmodified immunoglobulin G1 subtype with a functional Fc domain, and it is able to stimulate antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. According to experts, the recommended dose for cosibelimab is 1200 mg administered as an intravenous (IV) infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.3
CK-301-101 is an open-label, multicenter, multiregional, multicohort phase 1 trial that enrolled 109 patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation. All patients were treated with 800 mg of cosibelimab IV every 2 weeks. Patients were not included in the study if they had or experienced the following: active or suspected autoimmune disease; allogeneic transplant within 6 months prior to treatment; prior treatment with anti-PD-1/PD-L1 blocking antibodies or other immune checkpoint inhibitor therapy; uncontrolled or significant cardiovascular disease; Eastern Cooperative Oncology Group performance status score of 2 or more; or infection with HIV, hepatitis B, or hepatitis C.1-3
The study’s primary objectives are efficacy and tolerability of cosibelimab including objective response rate (ORR). Secondary end points include duration of response (DOR) and safety. According to the investigators, the study will consist of 3 periods: screening (up to 28 days); treatment (28-day cycles); and follow-up (up to 6 months of visits with survival follow-up for select cohorts). After the dose escalation portion of the study, additional evaluable subjects may be included in order to further characterize safety and efficacy at selected doses and/or in specific patient sub-groups.1-3
According to 2023 findings published in The Journal for Immunotherapy of Cancer, cosibelimab demonstrated both clinically meaningful ORR and DOR, as well as a manageable safety profile.3 Approximately 47.4% of patients with mCSCC (n = 37) achieved an ORR (95% CI: 36.0%-59.1%) with median follow-up of about 15.4 months (range: 0.4-40.5 months) as of data cut-off. At the time of this analysis, median DOR was not yet reached (range: 1.4+ to 34.1+ months), with response ongoing in approximately 73.0% of patients.1,3 For patients with laCSCC, approximately 48% (n = 31) achieved an ORR (95% CI: 30-67), and median DOR was about 17.7 months (range: ≥3.7-17.7) in patients with laCSCC.1
The most common AEs (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritis, edema, localized infection, and urinary tract infection.1 In the 2023 data, the most common treatment-emergent AEs (≥15%) were fatigue (26.9%), rash (16.7%), and anemia (15.4%). Approximately 23.1% of participants (n = 18) experienced immune-related AEs, of which 2 were grade 3 (2.6%). There were no grades 4 or 5 immune-related AEs or deaths related to treatment that were reported.3
REFERENCES
US Food & Drug Administration. FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma. News release. December 13, 2024. Accessed December 16, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cosibelimab-ipdl-metastatic-or-locally-advanced-cutaneous-squamous-cell-carcinoma
Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers.NCT03212404. Updated August 29, 2023. Accessed December 16, 2024. https://clinicaltrials.gov/study/NCT03212404
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
Related Videos
Related Content
