medwireNews: Pooled long-term results from two multicenter phase II studies indicate that nivolumab is efficacious in Japanese patients with previously treated, stage IIIB/IV squamous or nonsquamous non-small-cell lung cancer (NSCLC).
In this 3-year update of the ONO‐4538‐05 and ONO‐4538‐06 studies published in Cancer Medicine, Hidehito Horinouchi (National Cancer Center Hospital, Tokyo, Japan) and co-researchers report median overall survival (OS) of 16.3 months among the 35 participants with squamous NSCLC and 17.1 months for the 76 participants with nonsquamous NSCLC.
Estimated 1-, 2-, and 3-year OS rates were 71.4%, 37.1%, and 20.0%, respectively, among those with squamous NSCLC, and 68.0%, 37.4%, and 31.9% among those with nonsquamous disease. Median duration of response among the participants was 41.5 months.
These data reinforce the clinical efficacy of nivolumab in Japanese patients with either squamous or nonsquamous NSCLC noted in the primary analysis of the trials, the researchers say.
The team found that compared with the 81 patients who died within 3 years, the 30 patients who survived at least this long were significantly more likely to have received at least one prior systemic regimen (93.3 vs 76.5%) and to have wild-type or unknown EGFR mutation status (93.3 vs 75.3%).
And survival was also associated with response to therapy, with overall response rates (ORRs) of 66.7% in 3-year survivors versus just 7.4% in non-survivors, and 76.9% of the 26 responders surviving for at least 3 years.
The researchers also noted higher ORRs among patients who experienced treatment-related selected (ie, immune-related) adverse events (AEs), regardless of the severity of the AE. And in those with an immune-related AE, the risk for death was reduced by 59% and the risk for progression by 49% compared with those without such an event.
Analyzing these events by category, the team found that patients with a rash, endocrine disorders, or gastrointestinal toxicity had a significantly better ORR and 1-year OS rate than those without these AEs.
“The occurrence of these three toxicities has previously been correlated with the efficacy of anti‐PD‐1 antibodies, and the present data appear to support these findings,” say Horinouchi and colleagues.
They suggest that future research should “investigate approaches to increase the proportion of patients experiencing long-term survival, including combination studies with other immune checkpoint inhibitors or chemotherapies and the identification of specific biomarkers capable of predicting the response to these therapies.”
By Catherine Booth
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