KEY TAKEAWAYS
- The phase 2 trial aimed to assess the impact of cemiplimab on QoL in patients with mBCC unsuitable for HHI.
- Researchers noticed that cemiplimab treatment in patients with mBCC led to improved or maintained GHS.
A phase 2 cemiplimab study (NCT03132636) demonstrated a 24.1% objective response rate (ORR) in patients diagnosed with metastatic basal cell carcinoma (mBCC) who were not candidates for continued hedgehog inhibitor (HHI) therapy due to intolerance to previous HHI therapy, disease progression while receiving HHI therapy, or having not better than stable disease on HHI therapy after 9 months. This abstract reports on the health-related quality of life (QoL) for this patient population.
Ketty Peris and the team aimed to assess the impact of cemiplimab treatment on health-related QoL in these patients.
They performed an inclusive analysis of adult patients with mBCC treated with intravenous cemiplimab at a dose of 350 mg every 3 weeks for 5 treatment cycles of 9 weeks each, followed by 4 treatment cycles of 12 weeks each.
Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (QLQ-C30) and Skindex-16 questionnaires at baseline and on Day 1 of each cycle. Across Cycles 2 to 9, the overall change from baseline was analyzed using a mixed model with repeated measures. Responder analyses determined clinically meaningful improvement or deterioration (changes ≥10 points) or maintenance across all scales.
About patients reported low symptom burden and moderate-to-high functioning at baseline. Maintenance for QLQ-C30 global health status (GHS)/QoL and across all functioning and symptom scales was indicated by overall mean changes from baseline.
Clinically meaningful improvement or maintenance was reported at Cycle 2 for GHS/QoL (77%), functioning scales (77% to 86%), and symptom scales (70% to 93%), with similar proportions of improvement or maintenance at Cycles 6 and 9, excluding fatigue.
On the Skindex-16, clinically meaningful improvement or maintenance was reported across the emotional, symptom, and functional subscales, in 76%-88% of patients at Cycle 2, which were generally maintained at Cycles 6 and 9. Overall mean changes from baseline showed maintenance across these subscales.
The study concluded that the majority of patients treated with cemiplimab reported improvement or maintenance in GHS/QoL and functioning while maintaining a low symptom burden.
Funding support was provided by Regeneron Pharmaceuticals, Inc., and Sanofi.
Source: https://pubmed.ncbi.nlm.nih.gov/39031963/
Clinical Trial: https://clinicaltrials.gov/study/NCT03132636
Peris K, Inocencio TJ, Stratigos AJ, et al. (2024). “Health-related quality of life in patients with metastatic basal cell carcinoma treated with cemiplimab: Analysis of a phase 2 trial.” Cancer Med. 2024 Jul;13(14):e7360. doi: 10.1002/cam4.7360. PMID: 39031963; PMCID: PMC11259569.
