Evaluating the long-term outcomes of nivolumab plus ipilimumab versus chemotherapy as first-line treatment for advanced non-small cell lung cancer.

This evaluated the long-term outcomes of nivolumab (Opdivo) plus ipilimumab (Yervoy) versus chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC). The data showed that nivolumab plus ipilimumab increased the long-term overall survival versus chemotherapy in these patients.

NSCLC is the most common form of lung cancer. NSCLC is responsible for around 85% of all lung cancer diagnoses. Standard treatment for advanced NSCLC involves surgical removal of solid tumors, chemotherapy, and radiotherapy.

Immunotherapy uses the body’s own system to fight cancer. 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. Nivolumab and ipilimumab 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.

Immunotherapy in combination with other therapies such as chemotherapy and targeted therapy has been shown to significantly improve the outcomes of patients with advanced NSCLC. However, the long-term outcomes of nivolumab plus ipilimumab versus chemotherapy as first-line treatment for advanced NSCLC are still unknown.

This study involved 1739 patients with advanced NSCLC. Patients were randomly assigned into two groups based on how much PD-L1 was present in their tumors. Group 1 included 1189 patients who had PD-L1 in 1% or more of tumor cells. These patients either received nivolumab plus ipilimumab (NI; 396 patients), nivolumab alone (N; 396 patients), or chemotherapy alone (C; 397 patients). Group 2 included 550 patients who had PD-L1 in less than 1% of tumor cells. These patients either received NI (187 patients), nivolumab plus chemotherapy (NC; 177 patients), or chemotherapy only (C; 186 patients). The average follow-up time was 66.7 months.

In group 1, 24% of the patients who received NI were alive after 5 years versus 14% of the patients who received chemotherapy. In group 2, 19% of the patients who received NI were alive after 5 years versus 7% of the patients who received chemotherapy.

In group 1, the average duration of response to treatment without cancer growing or spreading was 24.5 months in patients who received NI versus 6.7 months in patients who received chemotherapy. In group 2, the average duration of response to treatment without cancer growing or spreading was 19.4 months in patients who received NI versus 4.8 months in patients who received chemotherapy.

Among patients who were alive after 5 years, 66% of the patients in group 1 and 64% of the patients in group 2 stopped treatment with NI and did not start any other treatment. In these patients, the 5-year overall survival rate was 39%.

This study concluded that nivolumab plus ipilimumab increased the long-term overall survival versus chemotherapy in patients with advanced NSCLC regardless of how much PD-L1 was present in their tumors.

This study was funded by Bristol Myers Squibb, the manufacturers of nivolumab and ipilimumab.