ESMO 2022 ABSTRACT 814P: Phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC): Final analysis from EMPOWER-CSCC-1 groups 1, 2, and 3

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ABSTRACT 814P: Phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell

carcinoma (CSCC): Final analysis from EMPOWER-CSCC-1 groups 1, 2, and 3

Speaker: Michael R. Migden


Background

Previous analyses from EMPOWER-CSCC-1 phase 2 study demonstrated substantial clinical benefit

and an acceptable safety profile with cemiplimab in patients with locally advanced and metastatic CSCC.

Here, we provide the final analysis from the study Groups 1, 2, and 3.


Methods

Patients received cemiplimab 3 mg/kg IV every 2 weeks for up to 96 weeks (Group 1, metastatic CSCC;

Group 2, locally advanced CSCC) or cemiplimab 350 mg IV every 3 weeks for up to 54 weeks (Group 3,

metastatic CSCC). The primary endpoint was objective response rate (ORR; complete + partial response)

per independent central review (ICR). This is the final analysis of EMPOWER-CSCC-1; the final database

lock occurred on 1 March 2022.


Results

A total of 193 patients were enrolled (Group 1, n=59; Group 2, n=78; Group 3, n=56). Tumor response

per ICR, median progression-free survival (PFS), and overall survival (OS) seen with cemiplimab remain

generally consistent with the previous update from EMPOWER-CSCC-1 (data cut-off: 11 October 2020).

Overall median duration of response (DOR) to cemiplimab was 41.3 months.




Overall survival (OS) at 48 months is 61.8% (95% CI: 54.0 to 68.7) for cemiplimab




Fatigue was the most common treatment-emergent adverse event (TEAE) of any grade (34.7%) for
patients receiving cemiplimab. Hypertension was the most common grade ≥ 3 TEAE (4.7%).





Conclusions

The final update confirms the durable response, safety, and efficacy of cemiplimab in patients with
advanced CSCC. There were no new safety signals identified on longer follow-up. Cemiplimab remains
a standard of care option for advanced CSCC.
Funding: Regeneron Pharmaceuticals and Sanofi




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