Regeneron Pharmaceuticals has announced that two Phase III clinical trials of Libtayo (cemiplimab) are currently recruiting advanced non-small cell lung cancer (NSCLC) patients.
Libtayo is a fully-human monoclonal antibody designed as an immune checkpoint inhibitor of the programmed cell death protein-1 (PD-1).
The drug was discovered by Regeneron, which reached a global joint development collaboration agreement with Sanofi.
The drug has approval to treat certain patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC in the US, Canada, EU and Brazil.
The Phase III NSCLC trials are assessing 350mg Libtayo given every three weeks as a monotherapy and combination treatment in first-line patients.
During the first open-label, randomised study, Libtayo monotherapy is being compared with standard-of-care platinum-based chemotherapy in participants with high PD-L1 expression.
The trail has already recruited 90% of its target of 700.
Following an interim analysis for overall survival (OS), the independent data monitoring committee said that the study could continue as per the planned protocol.
The objective response rate (ORR) in the initial 361 participants is 42% with Regeneron’s drug compared to 22% with chemotherapy.
The second, two-part trial is evaluating the drug in combination with platinum-based chemotherapy.
Part I, involving patients with PD-L1 expression of less than 50%, has concluded enrolment. It includes three groups for Libtayo plus chemotherapy, chemotherapy alone, and Libtayo plus chemotherapy and pilimumab.
Part II is a randomised, double-blind, placebo-controlled study that enrolled around 20% of planned subjects. It is designed for patients across all PD-L1 expression levels.
The second part will compare Libtayo plus chemotherapy with chemotherapy alone.
The drug is also being developed to treat other cancers, including basal cell carcinoma, cervical cancer, melanoma, multiple myeloma, Hodgkin lymphoma and non-Hodgkin lymphoma.