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Libtayo® (Cemiplimab-rwlc) Injection for Intravenous Use
Aditya K Gupta1,2, Avantika Mann3, Kimberly Vincent4
1Division of Dermatology, Department of Medicine, University of Toronto School of Medicine, Toronto, Ontario, Canada.
Skinmed
|August 1, 2024
Summary
Libtayo (cemiplimab-rwlc) shows antitumor activity in advanced basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (CSCC). This PD-1 inhibitor is approved for these advanced skin cancers, demonstrating an acceptable safety profile.
Area of Science:
- Oncology
- Immunotherapy
- Dermatology
Background:
- Libtayo (cemiplimab-rwlc) is a programmed death-1 (PD-1) pathway inhibitor.
- Libtayo is FDA-approved for advanced cutaneous squamous cell carcinoma (CSCC) and recently for advanced basal cell carcinoma (BCC).
Purpose of the Study:
- To evaluate the efficacy and safety of cemiplimab in patients with advanced basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (CSCC).
Main Methods:
- Two open-label, single-arm, phase 2 studies (NCT03132636 and NCT02760498) investigated cemiplimab in advanced BCC and CSCC.
- The primary endpoint was objective response rate (ORR) assessed by independent central review.
Main Results:
- In advanced BCC, ORR was 21% for metastatic BCC (mBCC) and 31% for locally advanced BCC (laBCC).
- In advanced CSCC, ORR ranged from 41% to 49% across different treatment arms and disease stages (mCSCC and laCSCC).
- Cemiplimab demonstrated an acceptable safety profile and antitumor activity.
Conclusions:
- Cemiplimab exhibits significant antitumor activity and an acceptable safety profile in patients with advanced BCC and CSCC.
- The recommended dosage is 350 mg intravenously every 3 weeks for both advanced BCC and CSCC.
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