Cemiplimab Shows Promise in Treating Non-Small Cell Lung Cancer

Regeneron's PD-1 Inhibitor Receives FDA Approval

The US Food and Drug Administration (FDA) has granted accelerated approval to cemiplimab-rwlc (Libtayo) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy.

Cemiplimab is a monoclonal antibody that blocks the PD-1 immune checkpoint receptor. PD-1 is expressed on the surface of T cells, and its interaction with its ligands, PD-L1 and PD-L2, inhibits T cell activation. By blocking PD-1, cemiplimab can enhance the antitumor activity of T cells.

Clinical Trial Results

The approval of cemiplimab is based on the results of the Phase 2 EMPOWER-Lung 1 trial, which included 278 patients with locally advanced or metastatic NSCLC who had progressed on or after platinum-based chemotherapy.

The trial showed that cemiplimab monotherapy resulted in an objective response rate (ORR) of 16.9% and a median duration of response (DOR) of 4.8 months. The median progression-free survival (PFS) was 2.3 months, and the median overall survival (OS) was 8.7 months.

Safety and Tolerability

Cemiplimab was generally well-tolerated in the EMPOWER-Lung 1 trial. The most common adverse events included fatigue (45%), rash (36%), musculoskeletal pain (31%), and diarrhea (30%).

Mechanism of Action

Cemiplimab is a human monoclonal antibody that binds to the PD-1 receptor on the surface of T cells. PD-1 is an inhibitory immune checkpoint receptor that, when bound to its ligands, PD-L1 and PD-L2, suppresses T cell activation and cytotoxicity. By blocking PD-1, cemiplimab can reinvigorate T cell function and promote antitumor immune responses.

Clinical Efficacy

The clinical efficacy of cemiplimab has been demonstrated in several clinical trials, including the Phase 2 EMPOWER-Lung 1 trial, which led to its accelerated approval by the FDA for the treatment of locally advanced or metastatic NSCLC. In the EMPOWER-Lung 1 trial, cemiplimab monotherapy resulted in an ORR of 16.9% and a median DOR of 4.8 months. The median PFS was 2.3 months, and the median OS was 8.7 months.

Safety and Tolerability Profile

Cemiplimab has a favorable safety and tolerability profile. The most common adverse events reported in clinical trials include fatigue, rash, musculoskeletal pain, and diarrhea. These adverse events are généralement manageable and do not typically lead to discontinuation of treatment.

Conclusion

Cemiplimab is a promising new treatment option for patients with locally advanced or metastatic NSCLC who have progressed on or after platinum-based chemotherapy. Its favorable safety and tolerability profile and demonstrated clinical efficacy make it a valuable addition to the treatment armamentarium for this difficult-to-treat patient population.