Preliminary findings from the phase 2 AliCe study found combining avelumab, a PD-L1 inhibitor, with cetuximab, an EGFR-inhibitor, exhibited high clinical activity and tolerable safety among patients with advanced, unresectable cutaneous squamous cell carcinoma (cSCC).

These results will be presented at the European Society for Medical Oncology Congress in Madrid, Spain, by lead author Juergen C. Becker, MD, PhD, University of Duisburg-Essen, Germany.

According to Dr Becker and coauthors, “in cSCC, both PD-1- and EGFR-inhibitors are effective, but durable tumor control, especially in anogenital cSCC, is still limited…for the latter, and refractory patients, there is an unmet medical need.”

In this multicenter study, 54 patients with unresectable, stage 3/4 cSCC were treated with 10 mg/kg avelumab plus 500 mg/m² of cetuximab once every 2 weeks for up to 1 year. Patients who received at least 1 dose were enrolled in the safety analysis cohort (n = 51; 31.4% primary anogenital cSCC) and patients treated for at least 12 weeks were enrolled in the per protocol cohort (n = 37; 21.6% primary anogenital cSCC). Primary end points included progression-free survival (PFS) and overall survival (OS). 

At a median follow up of approximately 2.5 years, median PFS was 9.2 months and median OS was 25.4 months in the per protocol cohort. In the safety analysis cohort, median PFS was 8.4 months and median OS was 17.4 months. No differences in PFS and OS were observed upon subgroup analysis by tumor stage, location of primary tumor, or prior treatment. 

Grade ≥3 adverse events were common but, grade ≥3 adverse drug reactions only occurred in approximately 20% of patients. Only 2 patients discontinued treatment due to adverse drug reactions including abnormal ECG and sarcoid-like lesions. 

“Avelumab plus cetuximab is a feasible treatment option in patients with cSCC,” concluded Dr Becker and coauthors. “This combination shows remarkable activity even in patients in whom PD-1 blockade has low efficacy, such as anogenital cSCC, or after failure of anti-PD-1 monotherapy.”

Source:

Becker, JC, Schilling B, Leiter-Stoppke U, et al. A single arm phase II, multicenter trial to evaluate the clinical activity and safety of avelumab plus cetuximab in unresectable stage III or IV cutaneous squamous cell carcinoma: First results from the AliCe study. Presented at the 2023 ESMO Congress; October 20- 24, 2023; Madrid, Spain. Abstract 1087MO