Promising recent clinical trial data for Boehringer Ingelheim’s tyrosine kinase inhibitor (TKI) Gilotrif (afatinib) will strengthen the drug’s position in non-small cell lung cancer (NSCLC) treatment markets outside the U.S., says an analyst with research and consulting firm GlobalData.
The LUX-Lung 7 trial showed Gilotrif to reduce the risk of adenocarcinoma progression for patients with epidermal growth factor receptor (EGFR) mutations by 27% compared with one of its closest rivals, AstraZeneca’s Iressa (gefitinib). The differential in progression-free survival at 18 months was 27% for Gilotrif and 15% for Iressa, increasing further at 24 months, to 18% and 8%, respectively.
According to Cai Xuan, Ph.D., GlobalData’s analyst covering Oncology and Hematology, these recent trial results suggest that Gilotrif may have superior long-term efficacy to Iressa, which will encourage uptake in NSCLC markets in Europe and Asia.
Xuan explains: “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.
“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.”
While Gilotrif is expected to gain significant market share as a first-line treatment in European and Asian markets which have traditionally favoured Iressa, the US market will likely continue to be dominated by Genentech/Astellas Pharmaceuticals’ Tarceva (erlotinib).
Xuan explains: “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. 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 two drugs, they are viewed to be similar in their clinical efficacy and cost. 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.”
Filed Under: Drug Discovery