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