ESMO 2021: Extended-Dose Cemiplimab-rwlc Under Study in Squamous Cell Carcinoma
Posted: Monday, September 20, 2021
Danny Rischin, MD, of Peter MacCallum Cancer Centre, Melbourne, Australia, and colleagues presented primary analysis data on treatment with extended-dose cempilimab-rwlc in patients with advanced cutaneous squamous cell carcinoma. Presented during the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract 1066P), these results appear to support the use of this dosage regimen of the monoclonal antibody by demonstrating similar efficacy, safety, and pharmacokinetic data to the standard-dose regimen.
This phase II trial focused on 63 patients with metastatic (n = 39) and locally advanced (n = 24) cutaneous squamous cell carcinoma. They received 600 mg of intravenous cemiplimab every 4 weeks for up to 48 weeks. Participants underwent tumor assessments every 8 weeks.
The median patient age was 74 years, and the majority (84%) of patients were male. Prior systemic therapy was received by 14% of individuals. At the median follow-up of 9.2 months, the objective response rate was 58.7%, and the rate of complete response was 17.5%. Although the median duration of response had not been reached, the Kaplan-Meier estimation of ongoing response at 12 months was 89.4%. Furthermore, the rate of durable disease control was 76.2%.
The observed mean serum concentration of extended-dose cemiplimab was 281 mg/L, with a mean trough concentration of 62.5 mg/L. Treatment-emergent adverse events such as pruritus, diarrhea, and fatigue affected 15, 15, and 14 patients, respectively. Additionally, grade 3 or higher immune-mediated adverse events were observed in eight patients.
Disclosure: For full disclosures of the study authors, visit oncologypro.esmo.org.
