Gilotrif shows significant reduction in the risk of adenocarcinoma progression.
Promising data from a clinical trial for a tyrosine kinase inhibitor (TKI) that treats non-small cell lung cancer (NSCLC) shows the drug may alter treatment markets for the disease, according to research and consulting firm GlobalData.
The results of the LUX-Lung 7 trial showed that patients with epidermal growth factor receptor (EGFR) mutations administered Boehringer Ingelheim’s afatinib (Gilotrif) had a reduction in the risk of adenocarcinoma progression by 27%.
When comparing progression free survival between Gilotrif and its close rival gefitinib (Iressa), researchers found the survival rate was 27% for Gilotrif and 15% for Iressa at 18 months. When treatment was increased to 24 months, the survival rate was 18% for Gilotrif and 8% for Iressa.
“In addition to Gilotrif’s impressive progression-free survival data, more patients responded to Gilotrif treatment than Iressa, with response rates of 70% and 56%, respectively,” said GlobalData analyst Cai Xuan, PhD. “Despite this, it must be acknowledged that the frequency of serious adverse events was higher for Gilotrif than for Iressa, at rates of 44.4% and 37.1%, respectively. However, the treatment discontinuation rate for both drugs was 6.3%, as reported by Boehringer Ingelheim.”
Researchers expect Gilotrif to gain significant market shares as a first-line treatment option in the Asian and European markets, despite the favoring of Iressa. However, the US market is currently dominated by erlotinib (Tarceva), which is unlikely to change.
“Gilotrif’s lack of success in the US is partially attributable to its lack of clinical superiority and slightly inferior safety profile in comparison to Tarceva,” Xuan said. “Unlike Tarceva, which is a reversible inhibitor of EGFR, Gilotrif is an irreversible inhibitor of EGFR with slightly increased toxicity.”
"Although no direct comparison data are available for the 2 drugs, they are viewed to be similar in their clinical efficacy and cost,” Xuan continued. “Thus, with an approval that lagged behind that of Tarceva’s, Gilotrif has not been viewed as a superior option in the first-line EGFR-mutant NSCLC setting.”