FDA has recently granted an approval to Cemiplimab-rwlc for management of patients with locally advanced and metastatic basal cell carcinoma (BCC), who had been treated previously with hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate.
Cemiplimab is a monoclonal antibody working against programmed death 1 (PD-1) receptors present on the cell surface. This antibody blocks the PD-1 receptor, thus hinders the binding and stimulation of PD-L1 and PD-L2. This is known to activate the T-cell mediated immune responses against tumor cells.
The FDA approval of Cemiplimab-rwlc was based on an open-label, non-randomized, multicenter trial of patients with locally advanced BCC or metastatic BCC. There were a total of 132 patients in the analysis, with 122 present in the efficacy analysis.
The eligibility criteria for selected patients was patients on HHI therapy, had no objective response following 9 months of therapy or were intolerant to their prior HHI therapy. All patients obtained 350 mg Cemiplimab-rwlc every 3rd week for up to 93 weeks till the completion of decided therapy, disease progression or unwelcomed toxicity.
Duration of response (DOR) and confirmed objective response rate (ORR) are considered as primary outcomes. Further, ORR was the major outcome for patients with no visible target lesions (metastatic form). For patients with externally visible target lesions (both locally advanced and metastatic form), composite response assessment with digital medical photography was used.
Amongst 84 patients with locally advanced BCC, the ORR found to be 29% with median DOR not achieved. The percentage of responders who maintained their response upto 6 months were 79. Further, amongst 28 patients with mBCC, the ORR found to be 21% with unachieved median DOR. Here, the percentage of responders who maintained their response upto 6 months were 100.
|Confirmed objective response rate (ORR)
|Duration of response (DOR)
|Locally Advanced BCC
Severe adverse events noticed during the trial were infusion reactions and immune-associated problems like colitis, diabetes, hyper or hypothyroidism, pneumonitis, nephritis, adrenal insufficiency and hepatitis. Other than these, the most common side effects found to be musculoskeletal pain, pruritus, fatigue, rash and diarrhea.
Considering the proven efficacy and safety of Cemiplimab-rwlc, it can be utilized for the treatment of locally advanced BCC after HHI treatment.
|Original Title of the Article
|FDA approves cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma