Eisai has begun to lay the groundwork for a slate of marketing applications in the U.S., Europe and Japan for a new thyroid cancer therapy after wrapping up a successful Phase III study of the drug, which is also noteworthy for relying on an innovative collaborative approach to the development process
The Phase III SELECT trial found that lenvatinib compared to a placebo produced a statistically significant improvement in progression-free survival, the primary endpoint. Investigators recruited 392 patients in 100 sites.
That news is a solid plus for SFJ Pharmaceuticals, a startup trial operation that funded the study under a new development model hatched back in 2011. SFJ fronted the cash for the study in exchange for a set of milestones for a successful outcome of the study, which was conducted by Eisai. This new model for drug development that has attracted considerable attention at Pfizer and other pharma operations looking to spread the risk and cost of R&D.
"These results show the potential role of the investigational drug lenvatinib in this rare, hard-to-treat cancer," said Kenichi Nomoto, the president of Eisai's Oncology Product Creation Unit, in a press release. "RR-DTC remains an unmet need with a limited number of treatment options." The drug is an oral inhibitor of select receptor tyrosine kinases, including VEGFR 1-3, FGFR 1-4, PDGFR-β, KIT and RET involved in angiogenesis and tumor proliferation.
Eisai says it has several other Phase III and Phase II studies of the drug underway in other tumor types. The company has also reported plans to get the drug made at one of its U.K. facilities.
- here's the press release
CORRECTION: An earlier version of this story reported that SFJ had conducted the study. SFJ paid for the study, which was conducted by Eisai.