Background Nivolumab is indicated for the treatment of patients with squamous and non-squamous non-small cell lung cancer (NSCLC) locally advanced or metastatic after failure of chemotherapy. French marketing authorisation approval for this immunotherapy was based on two pivotal studies, Checkmate-017 and Checkmate-057 for squamous and non-squamous NSCLC, respectively. They demonstrated a significant responder rate (20%) and a good safety profile: 10% serious adverse events (SAE). Immunotherapy represents an innovative therapeutic alternative, but financial costs are high.

Purpose To present the safety and efficacy of nivolumab in patients treated for lung cancer.

Material and methods A retrospective cohort study was conducted on patients who received at least one cycle of nivolumab from March 2015 to February 2016, with follow up until September 2016. A scan was performed every 2 months and evaluated using RECIST 1.1 criteria. In the case of progression on the first scan, depending on the patient’s clinical condition, the treatment could be continued until the second assessment. In case of progression or SAE, treatment was discontinued.

Results 73 patients were included in the study (35–90 years old, mean age 66 years), 28% squamous and 72% non-squamous NSCLC. 33 patients followed a secondline treatment, 21 a thirdline and 19 a fourthline or more. After the fourth cycle (C4), the first evaluation revealed partial or complete response for 25% of patients, stability for 30% of patients and progression for 37% of patients. 8% of patients discontinued the treatment early. Among progressions, 16 patients continued treatment until the C6 evaluation, assuming a pseudo-progression, and the response was seen in only 2 patients. At 1 March 2016, 22% patients were still under treatment, with an average of 21.9 cures (range 12–35). 12% of patients experienced SAE: 5 pneumonitis grades 3 and 4, 1 grade 3 diarrhoea, 1 grade 3 colitis, 1 grade 4 hepatitis and 1 grade 4 diabetic ketoacidosis.

Conclusion The responder rate in C4 patient and the safety profile of nivolumab (25%) seem to be consistent with pivotal studies. The high number of pneumonitis among SAE justify particular vigilance. The long term follow-up of this cohort will consolidate these results.

No conflict of interest