5-Year Follow-up of Patients Receiving Immunotherapy for Previously Treated Advanced NSCLC


Key Points

  • A total of 16% of patients had 5-year survival.
  • Among 16 patients with 5-year survival, 4 had best response of progressive disease or stable disease during initial treatment. 

As reported in the Journal of Clinical Oncology by Gettinger et al, 5-year follow-up of patients receiving nivolumab (Opdivo) in a phase I study (CA209-003) in previously treated advanced non­–small cell lung cancer (NSCLC) has shown prolonged survival and durable responses in a subgroup of patients.

Study Details

The study involved 129 patients with pretreated advanced NSCLC who received nivolumab 1, 3, or 10 mg/kg every 2 weeks in 8-week cycles for up to 96 weeks. As was previously reported, objective response was observed in 22 patients (17.1%) in the NSCLC cohort of the trial.

5-Year Survival

Estimated 5-year overall survival was 16% among all patients, with rates of 16% and 15% among those with squamous and nonsquamous disease. Among the 16 patients surviving for at least 5 years, 14 (88%) were current or former smokers. Of the 16 patients, 12 (75%) were among those with initial objective response to treatment, with the remaining four survivors having progressive disease (n = 2) or stable disease (n = 2) as best response during treatment; two of these patients received no further systemic therapy. Among the 5-year survivors, nivolumab dose was 1 mg/kg in three, 3 mg/kg in seven, and 10 mg/kg in six. No clear differences in baseline characteristics were observed between the responders who did vs did not achieve 5-year survival. Of 10 5-year survivors with available data, 7 (70%) had programmed cell death ligand 1 (PD-L1) expression ≥ 1% at baseline. Among the 16 survivors, 9 (56%) completed the maximum 96 weeks of nivolumab, 4 (25%) discontinued early due to adverse events, and 3 (19%) discontinued due to disease progression. As of database lock in November 2016, 12 of the 5-year survivors (75%) had received no subsequent therapy and were without evidence of disease progression at last follow-up.

The investigators concluded, “Nivolumab treatment resulted in long-term [overall survival] and durable responses in a proportion of patients with pretreated advanced NSCLC. Long-term survivors had diverse baseline and on-treatment characteristics.”

The study was supported by Bristol-Myers Squibb and ONO Pharmaceutical.

Scott Gettinger, MD, of Yale Cancer Center, Yale University School of Medicine, is the corresponding author for the Journal of Clinical Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.