(Cervical Cancer) Libtayo (Cemiplimab) Launched in Japan for Recurrent/Progressive Disease
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- March 30, 2023
- 1 min read
On March 30, 2023, Sanofi Japan announced the commercial launch of Libtayo (cemiplimab) IV infusion, an anti-PD-1 antibody drug, for the treatment of cervical cancer that has progressed or recurred following chemotherapy.
Cervical cancer is most commonly caused by HPV infection. Approximately 80% of cases are squamous cell carcinoma, with the remainder being primarily adenocarcinoma. Treatment options are limited for patients with progressive or recurrent disease.
This approval is based on the EMPOWER-Cervical 1 Phase 3 clinical trial, an international multicenter study enrolling patients (N=608) with recurrent or metastatic cervical cancer. Patients were randomized to receive Libtayo (350 mg every 3 weeks as second-line therapy, N=304) or investigator's choice of chemotherapy (N=304). The primary endpoints were overall survival (OS) and progression-free survival (PFS).
Key Results:
- Median OS: Libtayo 12.0 months vs. chemotherapy 8.5 months — statistically significant improvement
Sanofi Japan stated that the company will continue to collaborate with co-developer Regeneron to bring hope to cervical cancer patients in Japan, and to further contribute to patients, families, and healthcare providers.
Source: https://www.sanofi.co.jp/dam/jcr:0a6fdb34-9135-4f48-9c4a-ff178bcb58fc/230330.pdf
Cervical Cancer | Immunotherapy | Libtayo | Cemiplimab
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