medwireNews: Nivolumab continues to offer survival benefits over docetaxel for at least 3 years among CheckMate 017 and 057 participants with previously treated, advanced non-small-cell lung cancer (NSCLC), study data show.
The two studies initially found that nivolumab (3 mg/kg every 2 weeks) significantly improved overall survival (OS), with a favorable safety profile, compared with docetaxel (75 mg/m2 every 3 weeks) in patients with stage IIIB or IV squamous (CheckMate 017) and nonsquamous (CheckMate 057) NSCLC.
The patients had all progressed on or after platinum-based chemotherapy, while the CheckMate 057 patients with EGFR or ALK aberrations may also have undergone tyrosine kinase inhibitor therapy.
After a minimum 40.3 months of follow-up, the researchers found that OS was still significantly better with nivolumab than with docetaxel. In the pooled population of 854 patients from both studies, the estimated 3-year OS rates were 17% versus 8%. This was equivalent to a significant 30% reduction in the risk for death among patients receiving nivolumab.
The corresponding 3-year progression-free survival rates were 10% with nivolumab versus less than 1% with docetaxel.
At 3 years, seven (5%) of 131 patients with squamous NSCLC and 19 (7%) of 287 with nonsquamous NSCLC were still receiving treatment with nivolumab, compared with none of those assigned to use docetaxel. And among 83 confirmed responders in the nivolumab group, 20 (24%) had ongoing responses after at least 3 years. There were no ongoing responses in the docetaxel group at this time.
Everett Vokes (The University of Chicago Medicine, Illinois, USA) and team also analyzed data for a subgroup of 193 patients from both studies who had baseline liver metastases.
Similar results were observed among these patients, with 3-year OS rates of 8% versus 2% for nivolumab and docetaxel, respectively, which corresponded to a 32% reduced risk for death.
The researchers note that no new safety concerns had appeared since the previous analysis at 2 years. Nivolumab remained well tolerated, with the most common treatment-related adverse events being skin-related.
The findings were similar among the patients with liver metastases, with the exception of a slight increase in treatment-related hepatic adverse events (generally grade 1–2 liver enzyme elevations) in nivolumab-treated patients with liver metastases (10%) compared with the overall pooled population (6%). However, none of these events resulted in treatment discontinuation.
Writing in the Annals of Oncology, Vokes et al conclude: “These updated analyses from CheckMate 017 and CheckMate 057 demonstrate long-term clinical benefit with nivolumab in previously treated patients with advanced squamous and non-squamous NSCLC, including those with liver metastases.”
By Laura Cowen
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