The FDA ( Food and Drug Administration ) has approved Cemiplimab-rwlc ( Libtayo, Cemiplimab ) for patients with metastatic cutaneous squamous cell carcinoma ( CSCC ) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
Approval was based on clinically meaningful and durable objective response rates ( ORR ) observed in patients with advanced cutaneous squamous cell carcinoma who were treated with Cemiplimab-rwlc in two clinical trials: R2810-ONC-1423, an open-label, multi-center, dose-finding trial with expansion cohorts in patients with various advanced solid tumors; and R2810-ONC-1540, an open-label, multi-center, non-randomized, multicohort trial in patients with metastatic or locally advanced cutaneous squamous cell carcinoma regardless of prior treatment, for whom surgery or radiation was not recommended.
Overall response rate ( ORR ) was assessed by an independent review committee according to Response Evaluation Criteria in Solid Tumors ( RECIST ) 1.1 for patients with metastatic cutaneous squamous cell carcinoma.
A composite response assessment incorporating clinical response criteria using digital photography and RECIST 1.1 was used for those with locally advanced cutaneous squamous cell carcinoma.
Among 108 patients with advanced cutaneous squamous cell carcinoma, including metastatic ( n=75 ) or locally advanced ( n=33 ) disease, the ORR was 47% ( 95% CI: 38, 57 ), with 4% complete and 44% partial response rates.
The ORR was 47% (95% CI: 35, 59) for the 75 patients with metastatic cutaneous squamous cell carcinoma and 49% ( 95% CI: 31, 67 ) for those with locally advanced disease.
The median response duration was not reached ( range: 1.0 to 15.2+ months ), and 61% of responses were durable for 6 months or longer.
Response rates and durability results were consistent across the advanced CSCC subtypes.
For patients with locally advanced cutaneous squamous cell carcinoma, radiographic response rate correlated with clinically relevant shrinkage of visible and often disfiguring tumors demonstrated in the photographic data.
Safety data were evaluated in 534 patients who received Cemiplimab-rwlc in both trials.
Serious adverse reactions are immune-mediated adverse reactions ( e.g., pneumonitis, hepatitis, colitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus and nephritis ) and infusion reactions.
The most common adverse reactions were fatigue, rash and diarrhea.
The recommended cemiplimab-rwlc dose and schedule is 350 mg as an intravenous infusion over 30 minutes every 3 weeks. ( Xagena )
Source: FDA, 2018