Reference Detail

Ref Type

PMID

Authors

A.J. Stratigos A. Sekulic K. Peris O. Bechter C. Dutriaux M. Kaatz K.D. Lewis N. Basset-Seguin A.L.S. Chang S. Dalle A. Fernandez-Orland L. Licitra C. Robert C. Ulrich A. Hauschild M.R. Migden R. Dummer S. Li T. Bowler M.G. Fury

Title

Primary analysis of phase II results for cemiplimab in patients (pts) with locally advanced basal cell carcinoma (laBCC) who progress on or are intolerant to hedgehog inhibitors (HHIs)

Journal	Vol	Issue	Date	Pages	Journal Short Title
Annals of Oncology	31	suppl_4

URL

https://www.annalsofoncology.org/article/S0923-7534(20)42359-2/fulltext

Abstract Text

Background There is no approved therapeutic option post-HHI for pts with laBCC. Cemiplimab, an antibody to PD-1, is an established therapy approved for treatment of advanced cutaneous squamous cell carcinoma (CSCC) in pts who are not candidates for curative surgery or curative radiation. Both BCC and CSCC are keratinocytic tumours with high mutational burden due to ultraviolet mutagenesis and are potentially amenable to immunotherapy. We present the primary analysis of the laBCC cohort from the pivotal phase II study of cemiplimab in the second-line (or greater) setting. Methods Pts with laBCC received cemiplimab 350 mg Q3W IV (for up to 93 weeks or until progression). The primary endpoint was objective response rate (ORR) by Independent Central Review (ICR). Secondary objectives included assessment of safety and tolerability, estimation of duration of response (DOR), progression-free survival (PFS) and overall survival (OS). ORR included two responses confirmed after the data cut-off date of 17 February 2020. Results 84 pts were enrolled; 66.7% male; median age was 70 years (range: 42−89). Median follow-up was 15 months (range: 0.5−25). ORR per ICR was 31% (95% CI: 21−42), including five complete responses and 21 partial responses. Median DOR has not been reached; an estimated 85% of responses were ongoing at 12 months, per the Kaplan–Meier method. Median PFS and OS had not been reached. Estimated PFS for all patients was 19 months. The most common adverse events (AEs) were fatigue (30%), diarrhoea (24%) and pruritus (21%); 17% of patients discontinued treatment due to AEs. Median baseline tumour mutational burden (TMB) was 58.2 and 23.5 mutations/Mb among responding (n=18) and non-responding (n=38) pts, respectively, but responses occurred at all TMB levels. Exploratory biomarker analysis identified downregulation of major histocompatibility complex-I expression as a potential immune evasion mechanism in non-responding BCCs with high TMB. Conclusions Cemiplimab is the first agent to establish clinical benefit for pts with laBCC who progress on or are intolerant to HHI therapy, regardless of biomarker status.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References