1141P - Early discontinuation of cemiplimab in patients with advanced cutaneous squamous cell carcinoma

Background

Immunotherapy has drastically changed the treatment of advanced cutaneous squamous cell carcinoma. In three clinical trials, cemiplimab and pembrolizumab have been administered up to 24 months, although most objective responses have been observed within the first 3 months. To determine if a shorter exposure time to cemiplimab was associated with the long-term maintenance of clinical activity, we assessed the outcomes of patients with advanced cutaneous squamous cell carcinoma that had an early discontinuation of cemiplimab.

Methods

This is a single centre retrospective study including patients with histologically confirmed locally advanced or metastatic CSCC treated with cemiplimab at our Institution from August 19th, 2019, to August 8th, 2022. The objective response was assessed radiologically according to the RECIST 1.1 criteria or clinically according to the WHO criteria.

Results

A total of 48 patients receiving at least one dose of cemiplimab were included. Median time of treatment with cemiplimab was 6.8 (0 – 31.6) months, with an overall response rate (ORR) of 68%. Median time to response was 2.8 (0.6 - 19.1) months. Therapy was permanently discontinued in 20 patients due to adverse events (n=3) or patients' or physician’s choice after achieving a stable disease, partial or complete response (n=17). At a median follow-up of 11.6 (1.4 – 45.0) months, the median PFS after treatment discontinuation was 15.8 months. No patient relapsed. Only one patient, after being treated for a haematological pathology, developed a new primary CSCC, while pre-existing lesions maintained complete clinical response.

Conclusions

Our findings suggest that early discontinuation of cemiplimab in patients with advanced CSCC upon achieving a tumour response does not appear to negatively impact on the duration of response.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Italian Ministry of Health (Ricerca Corrente).

Disclosure

C. Genova: Financial Interests, Personal, Invited Speaker, Speaker's Bureau (scientific meeting): AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Eli Lilly, Novartis; Financial Interests, Personal, Advisory Board, Advisory board: Amgen, Sanofi; Financial Interests, Personal, Advisory Board, Advisory Board: Roche, Takeda; Financial Interests, Institutional, Funding, Funding for support of translational study: Bristol Myers Squibb; Financial Interests, Institutional, Funding, Funding for support of translational study: AstraZeneca; Financial Interests, Institutional, Research Grant, Research Grant for translational study: Italian Ministry of Health; Non-Financial Interests, Principal Investigator, Local PI for clinical trials: AstraZeneca, Roche; Non-Financial Interests, Member, Scientific society membership: ASCO, AIOM, FONICAP, AIOT, IASLC, ISLB. M. Lambertini: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Lilly, Novartis, Pfizer, Exact Sciences, MSD, Seagen, Gilead; Financial Interests, Personal, Invited Speaker: Takeda, Sandoz, Ipsen, Libbs, Knight, Daiichi Sankyo, Lilly, Pfizer, Novartis, Roche; Financial Interests, Personal, Other, Travel grant to attend ASCO 2022: Gilead; Financial Interests, Institutional, Coordinating PI, 2-year research grant paid to my Institution: Gilead. L. Del Mastro: Financial Interests, Personal, Invited Speaker, Educational meeting: Novartis, Symposia, Andromeda E20, Vyvamed srl; Financial Interests, Personal, Invited Speaker, Lecture: Ipsen; Financial Interests, Personal, Advisory Board, Her2+ and TN breast cancer: Roche; Financial Interests, Personal, Writing Engagement, Consultancy for TNBC text: Roche; Financial Interests, Personal, Advisory Board, denosumab: Amgen; Financial Interests, Personal, Advisory Board, Early and metastatic BC: Eli Lilly; Financial Interests, Personal, Invited Speaker, CDK4-6 inhibitors: Eli Lilly; Financial Interests, Personal, Advisory Board, tucatinib: Seagen Int; Financial Interests, Personal, Advisory Board, Oncotype dx: Exact sciences, Havas life; Financial Interests, Personal, Advisory Board, Neratinib: Pierre Fabre; Financial Interests, Personal, Invited Speaker, Internal training: MSD; Financial Interests, Personal, Invited Speaker, Educational meetings: Accademia Nazionale Medicina; Financial Interests, Personal, Writing Engagement, Author for BC text: Pensiero Scientifico Editore; Financial Interests, Personal, Advisory Board, Breast cancer: Uvet; Financial Interests, Personal, Other, Author slide kits and interviews: Think2it; Financial Interests, Personal, Advisory Board, Palbociclib: Pfizer; Financial Interests, Personal, Invited Speaker, Breast cancer: Aristea, Meeting srl; Financial Interests, Personal, Other, Author slide kits: Forum service; Financial Interests, Personal, Other, Author text about biosimilars: Edizioni Minerva Medica; Financial Interests, Personal, Other, consultant: Kardo srl; Financial Interests, Personal, Invited Speaker, Breast cancer meetings: Delphi international, Over srl; Financial Interests, Personal, Invited Speaker: Prex srl, Editree; Financial Interests, Personal, Advisory Board: Uvet, Collage S.p.A., Daiichi Sankyo, AstraZeneca, Agendia, Gilead; Financial Interests, Personal, Other, Interview: Infomedica srl; Financial Interests, Personal, Other, Consultant: Sharing progress in cancer care - Switzerland; Financial Interests, Personal, Other, Consultancy: Eli Lilly; Financial Interests, Institutional, Funding, National coordinating PI: Roche; Financial Interests, Institutional, Funding, Local PI: AstraZeneca, Roche, Eli Lilly, Daiichi Sankyo, Novella Clinical, Novartis; Non-Financial Interests, Institutional, Product Samples, Genomic Test: FoundationOne. F. Spagnolo: Financial Interests, Personal, Other: Roche, BMS, Merck, Pierre Fabre, Sanofi Genzyme; Financial Interests, Personal, Advisory Board: Novartis, Sun Pharma, MSD, Philogen. All other authors have declared no conflicts of interest.