1087MO - 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

Background

In cutaneous squamous cell carcinoma (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 (pts), there is an unmet medical need.

Methods

Pts with unresectable stage III/IV cSCC were treated with PD-L1 inhibitor avelumab (10 mg/kg q2w) plus EGFR-inhibitor cetuximab (500 mg/m² q2w) for up to 1 year. The Safety Analysis (SAF) set was defined as pts who received at least 1 administration of study treatment, the per protocol (PP) set if treated for at least 12 weeks.

Results

54 pts were registered (SAF Set: 51 pts; PP Set: 37 pts). Two-thirds of pts had prior systemic treatment for cSCC, i.e. chemotherapy or PD-1 inhibition. 31.4% (SAF) and 21.6% (PP) of primaries were anogenital cSCC. Within a median follow up of ∼ 2.5 years, median PFS/OS were 8.4/17.4 months in the SAF and 9.2/25.4 months in the PP set, respectively. No significant differences in PFS and OS were observed when subgroups for tumor stage (III vs. IV), location of primary (anogenital vs. elsewhere), or prior treatment (yes vs. no) were analyzed. Adverse events (AE) >= grade 3 were common, but adverse drug reactions (ADR) >= grade 3 occurred only in ∼ 20% of pts, which is explained by the frailty of pts with advanced cSCC. Only two pts discontinued treatment due to ADR (abnormal ECG, sarcoid-like lesions). Table: 1087MO

Conclusions

Avelumab plus cetuximab is a feasible treatment option in patients with cSCC. 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.

Clinical trial identification

EudraCT 2018-001708-12.

Editorial acknowledgement

Legal entity responsible for the study

Dermatologic Cooperative Oncology Group (DeCOG/ADO).

Funding

Merck KGaA/EMD.

Disclosure

J.C. Becker: Financial Interests, Personal, Advisory Board: Amgen, Merck, Recordati, Sanofi, Boehringer Ingelheim, InProTher, Almirall; Financial Interests, Personal, Other, Member of a DMSB: 4SC; Financial Interests, Institutional, Research Grant: IQVIA, Alcedis, Merck; Non-Financial Interests, Institutional, Product Samples: 4SC. L. Zimmer: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Novartis, MSD, Sun Pharma, Pierre Fabre, Sanofi; Financial Interests, Personal, Other, Travel Support: Bristol Myers Squibb, MSD, Sun Pharma, Pierre Fabre, Sanofi, Novartis, Amgen; Financial Interests, Personal, Invited Speaker: Novartis, MSD, Pierre Fabre, Roche; Financial Interests, Personal and Institutional, Research Grant: Novartis; Non-Financial Interests, Member: German Cancer Society, Dermatologic Cooperative Oncology Group. J.C. Hassel: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Sanofi, MSD, Sun Pharma, Almirall, Roche, Amgen, GSK, Pierre Fabre; Financial Interests, Personal, Advisory Board: MSD, Pierre Fabre, Sun Pharma, GSK; Financial Interests, Institutional, Advisory Board: Novartis, BMS, Immunocore, Nektar, Philogen; Financial Interests, Institutional, Research Grant: BMS, Sun Pharma; Financial Interests, Institutional, Local PI: Philogen, Genentech, 4SC, BioNTech, Idera, Iovance, Nektar, Pierre Fabre, Regeneron, Sanofi; Financial Interests, Institutional, Coordinating PI: BMS, Immunocore, Novartis; Financial Interests, Institutional, Steering Committee Member: Immunocore; Non-Financial Interests, Leadership Role: DeCOG; Non-Financial Interests, Member: ASCO. All other authors have declared no conflicts of interest.