Human medicines European public assessment report (EPAR): Libtayo, cemiplimab, Carcinoma, Squamous Cell, Date of authorisation: 28/06/2019, Revision: 14, Status: Authorised
Cutaneous squamous cell carcinoma
Libtayo is effective at treating cutaneous squamous cell carcinoma in patients. In a main study involving a total of 193 patients, the cancer shrank in around 39% of patients with metastatic disease who received Libtayo every 3 weeks for around one year. Among patients with locally advanced disease who received Libtayo every 2 weeks for around 2 years, 44% of patients showed shrinkage of their cancer.
Basal cell carcinoma
Treatment with Libtayo showed benefits in patients with locally advanced and metastatic BCC. In a study involving patients who were given Libtayo for around one year, the cancer shrank in 32% (27 out of 84) of patients with locally advanced disease and 29% (10 out of 35) of patients with metastatic disease. Libtayo was not compared with another treatment in this study.
Non-small cell lung cancer
In a study involving 710 patients with advanced or metastatic EGFR/ALK/ROS1-negative NSCLC with high levels of PD-L1 (in more than 50% of tumour cells), patients treated with Libtayo lived longer (about 22 months on average) than those treated with platinum-based chemotherapy (about 14 months). Patients treated with Libtayo lived without their disease getting worse for 6.2 months on average, compared with 5.6 months for patients given chemotherapy.
A second study involving 466 patients with advanced or metastatic EGFR/ALK/ROS1-negative NSCLC found that in patients whose tumours produce PD-L1 in at least 1% of cells, Libtayo given with platinum-based chemotherapy increased the time that patients lived. Of the 327 patients with PD-L1 in at least 1% of tumour cells, those treated with Libtayo plus platinum-based chemotherapy lived for an average of 22 months compared with 13 months for those treated with platinum-based chemotherapy alone. In addition, patients treated with Libtayo plus chemotherapy lived for about 9 months without their disease getting worse, compared with 6 months for patients given chemotherapy alone.
Cervical cancer
In a main study in 608 patients with recurrent or metastatic cervical cancer previously treated with platinum-based chemotherapy, patients given Libtayo lived for about 12 months, compared with 8.5 months for those given chemotherapy. On average, patients treated with Libtayo lived without their disease getting worse for 2.8 months, compared with 2.9 months for patients given chemotherapy.
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