Anti-PD-1 immunotherapy cemiplimab is now listed on the PBS for first-line treatment of patients with metastatic non-small cell lung cancer in combination with platinum-based chemotherapy.

Sold under the brand name Libtayo, the immune checkpoint inhibitor works by binding to the PD-1 receptor to inhibit cancer cells from using the PD-1 pathway to suppress T-cell activation, enabling the immune system to attack cancer cells.

Cemiplimab was registered by the TGA last year based on the international Phase 3 EMPOWER-Lung 3 study (link here), which found a statistically significant improvement in overall survival for patients treated with the combination compared to chemotherapy alone, according to Sanofi.

The trial was conducted among 466 patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression or histology and with no EGFR, ALK genomic or ROS1 aberrations, with those treated with the combination showing a 22-month median overall survival compared to 13 months in those treated with only chemotherapy.

PBS eligibility criteria includes patients with no previous treatment in the metastatic setting or who have progressed after treatment with tepotinib (Tepmetko).

Patients must also not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for NSCLC, have a WHO performance status of 0 or 1, and have tumours with no EGFR, ALK, or ROS1 aberrations.

Oncologist Professor Nick Pavlakis from Royal North Shore Hospital, Sydney, said the listing would help many patients with advanced metastatic disease.

“Having access to another effective therapeutic option is important for the medical oncology community so that we can offer the most suitable treatment for each patient to meet their individual needs,” said the University of Sydney professor.

Special warnings and precautions for use include patients with immune-related adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, skin adverse reactions and nephritis) and infusion-related reactions.

The most common adverse events (grade ≥3), as reported in the EMPOWER-Lung 3 study, were anaemia and neutropenia.

Last November, the drug was also listed on the PBS for certain patients with cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

Sanofi and Regeneron jointly developed the drug.