Evaluating the effectiveness and safety of cemiplimab plus chemotherapy as first-line treatment in patients with advanced non-small cell lung cancer.

This study evaluated the effectiveness and safety outcomes of cemiplimab (Libtayo) plus chemotherapy as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC). The data showed that cemiplimab plus chemotherapy as first-line treatment was effective with manageable side effects in these patients.

NSCLC is the most common form of lung cancer. It is responsible for around 85% of all lung cancer cases worldwide. Despite current treatment options improving survival rates, advanced NSCLC can be difficult to treat. Standard chemotherapy regimens usually contain drugs such as carboplatin (Paraplatin), which belong to the class of drugs called platinum analogs. These chemotherapeutic drugs inhibit the formation of new cells, thus delaying tumor growth and spread.

Immunotherapy has been found to be effective in advanced NSCLC. Tumor cells try to avoid death by switching off our immune system. They bind to proteins on the surface of the immune cells such as PD-1/PD-L1. These proteins can stop the immune system from killing cancerous cells. Cemiplimab and pembrolizumab (Keytruda) are examples of PD-1 and PD-L1 inhibitors that work by inhibiting (blocking) PD-1/PD-L1. This inhibition triggers the immune system to attack tumor cells and kills them.

PD-1/PD-L1 inhibitors plus chemotherapy as a first-line treatment have been found to significantly improve the outcomes of patients with advanced NSCLC. However, the effectiveness and safety of combining cemiplimab with chemotherapy as first-line treatment in patients with advanced NSCLC are still unknown.

This study involved 466 patients with stage III/IV NSCLC. Patients were randomly assigned into 2 groups. Group 1 included 312 patients who received cemiplimab plus chemotherapy. Group 2 included 154 patients who received a placebo plus chemotherapy. Chemotherapy involved combinations such as paclitaxel (Taxol) plus carboplatin, paclitaxel plus cisplatin (Platinol), pemetrexed (Alimta) plus carboplatin, and pemetrexed plus cisplatin. Treatment lasted for a maximum of 108 weeks followed by pemetrexed maintenance. The average follow-up time was 16.3 months.

The average survival without cancer worsening was 8.2 months in group 1 compared to 5 months in group 2. Patients in group 1 were 44% more likely to survive without cancer worsening than patients in group 2. After 1 year, 38.1% of patients in group 1 were alive without cancer worsening compared to 16.4% of patients in group 2.

The average overall survival was 21.9 months in group 1 compared to 13 months in group 2. Patients in group 1 were 29% more likely to have a better survival than patients in group 2. After 1 year, 65.7% of patients in group 1 were alive compared to 56.1% of patients in group 2.

The overall response rate (ORR; partial or complete disappearance of cancer) was 43.3% in group 1 compared to 22.7% in group 2.

Treatment-related side effects were similar between the 2 groups. The most common side effects were low red and white blood cell counts.

This study concluded that cemiplimab plus chemotherapy as first-line treatment was effective with manageable side effects in patients with advanced NSCLC.

This study was funded by Regeneron Pharmaceuticals, the manufacturer of cemiplimab. This study had a short follow-up period due to early closure as it met its objective.