Some patients with previously treated advanced non-small cell lung cancer (NSCLC), a malignancy with a historically dim prognosis, survived at least 5 years after receiving the immune checkpoint inhibitor nivolumab (Opdivo) in an early phase 1 trial.
For 129 patients with NSCLC treated with nivolumab in the, the estimated 5 year overall survival (OS) was 16%. Twelve patients who did not receive any subsequent therapy following completion of nivolumab were alive with no evidence of disease at the 5-year follow-up mark, reported , of the Yale Cancer Center in New Haven, Connecticut, and colleagues.
“Considering the historically low 5-year survival rate for patients with metastatic lung cancer, the estimated 5-year OS rate of 16% from the time of nivolumab treatment initiation observed in this cohort of heavily pretreated patients with advanced NSCLC constitutes a milestone in the advancement of lung cancer treatment,” they wrote in the. In the NSCLC cohort of the phase 1 dose-escalation and expansion study, 129 patients with heavily pretreated advanced NSCLC received nivolumab in doses of 1, 3, or 10 mg/kg intravenously once every 2 weeks in 8-week cycles for up to 96 weeks. The investigators that after a median follow-up of 39 weeks, the median overall survival across all three dose groups was 9.9 months. For 37 patients treated at the 3 mg/kg dose chosen for further development, the median 1-, 2-, and 3-year OS rates were 56%, 42%, and 27%, respectively.
In the current study, they followed the patients out to a minimum of 58.25 months. The median OS was 9.9 months, and the estimated 5-year OS rate, as noted before, was 16%. The 5-year OS rates for patients with squamous histology cancers was 16%, and the rate for patients with nonsquamous histology was 15%.
In all, 16 patients survived at least 5 years, with the longest follow-up out to 88.6 months. Two of the patients died before the database lock in November 2016, one from disease progression, and one from chronic obstructive pulmonary disease.
Among 10 long-term survivors who had quantifiable expression of the programmed death-1 ligand 1 (PD-L1), seven had at least 1% PD-L1 expression at baseline.
Of the 16 5-year survivors, 12 (75%) had a partial response to nivolumab according to RECIST (Response Evaluation Criteria in Solid Tumors), version 1. Two others had stable disease, and two had disease progression at the best response.