Cosibelimab-ipdl Approved for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
Expert Perspectives · Lyn Brook · 2024-12-16
The FDA has approved cosibelimab-ipdl (Unloxcyt™, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
Why Is the Approval of Cosibelimab Important?
“Cutaneous squamous cell carcinoma is the second most common form of skin cancer, making up ~20% of epithelial skin cancers,” wrote Philip Clingan, MD, Medical Oncologist at Southern Cancer Institute in New South Wales, Australia, and colleagues in their published results of the CK-301-101 trial (NCT03212404), on which approval was based. “The incidence of CSCC is rapidly increasing globally, owing to aging of the world’s population and increased exposure to risk factors such as ultraviolet radiation. However, CSCC remains a highly under-recognized disease, as it is excluded from most national cancer registries.”
Investigating Cosibelimab in CK-301-101
Efficacy was measured in the phase 1, open-label, multicenter, multicohort trial which enrolled 109 patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation. Key exclusionary criteria included active or suspected autoimmune disease, allogeneic transplant within six 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 (ECOG) PS ≥2, or infection with HIV, hepatitis B, or hepatitis C.
The primary efficacy outcomes measured were objective response rate (ORR) and duration of response (DOR) as assessed by an independent central review committee (IRC) according to RECIST v1.1. If a patient with laCSCC had externally visible target lesions not assessable by radiologic imaging, ORR was determined by independent central review (ICR) assessments of digital photography (WHO criteria).
The study revealed the following results:
- Patients with mCSCC had an ORR of 47%, and a median DOR was not reached
- Patients with laCSCC had an ORR of 48% and a median DOR of 17.7 months
Adverse Events
The most common adverse events experienced in ≥10% of patients receiving cosibelimab-ipdl were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritis, edema, localized infection, and urinary tract infection.
Putting It Into Context
“Cosibelimab demonstrated clinically meaningful ORR and DOR and was associated with a manageable safety profile,” concluded Dr. Clingan and colleagues.
Dosing Instructions
The recommended dosage of cosibelimab-ipdl is 1,200 mg administered as an intravenous infusion over 60 minutes every three weeks until disease progression or unacceptable toxicity.