KEY TAKEAWAYS
- The phase 2 study assessed the health-related quality of life (HRQoL) for mBCC pts.
- The study demonstrated that most mBCC pts had an improved HRQoL with the cemiplimab treatment.
In both the US and Europe, Cemiplimab is sanctioned for use in patients (pts) with locally advanced basal cell carcinoma (laBCC) and metastatic basal cell carcinoma (mBCC) who have previously undergone hedgehog inhibitor (HHI) treatment or, exclusively in the US, those for whom HHI isn’t suitable.
A Phase 2 clinical study reported that cemiplimab had an objective response rate of 24.1% (with a 95% confidence range of 13.5–37.6%) for mBCC pts who either didn’t respond well to HHIs or couldn’t tolerate them. Quality of life data linked to health for laBCC pts has been shared in the past. This specific study focused on the health-related quality of life (HRQoL) for mBCC pts.
Adults diagnosed with mBCC were administered 350 mg of cemiplimab intravenously every three weeks, up to nine treatments. On the first day of each cycle and at the outset, pts filled out the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (QLQ-C30) and the Skindex-16 surveys.
To gauge the overall average change from the beginning throughout Cycles 2–9, mixed-effects repeated-measures models were employed. Changes that surpassed or equaled 10 points were deemed significant in a clinical sense. Responder evaluations helped ascertain the fraction of pts experiencing significant clinical improvements, stability, or worsening across all scales.
Initial scores depicted mid to high functionality levels and a minimal symptom load. The average changes from the beginning showed consistency for QLQ-C30 global health, functioning, and symptom scales. In the responder’s feedback, significant clinical betterment or stability was observed in 77% of pts for GHS/QoL, 77–86% for functioning, and 70–93% for symptoms by the second cycle.
Similar figures were noticed at Cycle 6 (approximately a year into treatment), with the only deviation seen in fatigue by Cycle 9. With the Skindex-16, the general shifts from the beginning maintained emotional, symptom, and functional subscales. Responses showcased that 76–88% of pts at Cycle 2 experienced meaningful clinical enhancements or stability across all subscales, which largely persisted through Cycles 6 and 9.
Most mBCC pts receiving cemiplimab treatment showed consistent global health and functionality scores and continued to exhibit a low symptom burden.
Source: https://eado2023.com/wp-content/uploads/2023/04/Abstract-Band_EADO2023_Stand-21-04-2023-kl.pdf
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03132636
Lewis, K., Inocencio, T.J., Quek, R.G.W., LaFontaine, P.R., Eroglu, Z., Chang, A.L.S., Ivanescu, C., Stratigos, A., Peris, K., Sekulic, A., Fury, M., Chen, C-I. Health-related quality of life in patients with metastatic basal cell carcinoma treated with cemiplimab: Analysis of a Phase 2 open-label clinical trial.
