The first report of five-year overall survival (OS) data of nivolumab in patients with previously treated advanced non-small cell lung cancer has been featured at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington, D.C.

CA209-003 (NCT00730639) is a Phase 1b, open-label, multicenter, multidose, dose-escalation study of nivolumab in patients with select advanced or recurrent malignancies, including previously treated non-small cell lung cancer (NSCLC).

Overall survival was an exploratory endpoint in this study.

The estimated OS rate at five years was 16% in heavily pre-treated NSCLC patients; survival was observed across PD-L1 expression levels and tumour histologies.

The safety profile of nivolumab from this study was previously reported; no new safety signals were identified in this analysis.

In this study, patients received one to five prior systemic therapies for advanced NSCLC (n=129) and were treated with nivolumab (1, 3 or 10 mg/kg) intravenously once every two weeks for less than 96 weeks.

The primary objectives were measures of safety and tolerability, and secondary objectives include antitumour activity. 

Overall survival (OS) and analysis by PD-L1 expression levels were exploratory objectives.

The data reported at AACR 2017 represent pooled data across the three doses for the NSCLC cohort.

Scott N. Gettinger, M.D., a senior author of CA209-003 and associate professor of medicine, Yale Cancer Center, New Haven, Conn., commented, “Historically, five-year survival rates for patients with advanced NSCLC have been less than 5%. With new data emerging from the NSCLC cohort of CA209-003, we observe that the estimated five-year overall survival rate in nivolumab-treated patients in the study was 16%. In addition, based on investigator assessments, the majority of these patients showed no evidence that their lung cancer had progressed at the time of their last follow-up. These findings offer important new insights into the long-term clinical profile of nivolumab in this patient population.”

At five years, the estimated OS rate for patients treated with nivolumab at all doses was 16%, and the median OS was 9.9 months (95% CI: 7.8, 12.4), with a minimum follow-up of 58 months.

The five-year OS rates were consistent across histologies (squamous = 16% [n=54]; non-squamous = 15% [n=74]).

In patients with evaluable PD-L1 expression (n=68/129), five-year OS rates increased as the PD-L1 expression level increased.

Five-year OS rates were 20%, 23% and 43% in patients with PD-L1 expression <1%, ≥1% and ≥50%, respectively.

PD-L1 status was not evaluable in 47% of patients (n=61/129); the estimated five-year OS rate in patients with unknown PD-L1 status was 10%.

Based on investigators’ assessment, 75% (n=12/16) of patients remained without evidence of progressive disease at their last follow-up.

In the study, five-year survivors had variable length of time and disease course from diagnosis to nivolumab treatment initiation.

The median time from initial diagnosis to start of nivolumab was 1.2 years (range, 0.4 to 6.1 years).

Source: BusinessWire