Karyopharm Therapeutics Inc. (NASDAQ:KPTI) has announced that it has received a go-ahead from the data and Safety Monitoring Board to continue the Phase 3 SIENDO study. This comes after passing pre-specified preliminary futility analysis with a recommendation to continue with the study as planned without amending the study protocol or adding more patients.
SENDIO Study passes futility analysis test
Sharon Shacham, the company’s CEO, stated that they are delighted that the study passed its futility analysis and will now go on as previously planned. She said that the approval is a promising development for the SIENDO study and, most importantly, for patients who required novel treatment alternatives for recurrent or advanced endometrial cancer. Currently, there are no approved treatments in maintenance settings for advanced endometrial cancer patients. This makes future SIENDO study results more important, and Karyophram expects to release topline results from the study in 2H 2020.
The ongoing double-blind, multicentre, randomized Phase 3 SIENDO study seeks to evaluate safety and efficacy for front-line maintenance therapy with XPOVIO in advanced or recurrent endometrial cancer patients. The study randomized patients with recurrent or primary stage IV that had previously received a complete or partial response after a single line of standard taxane-platinum combined with chemotherapy 2:1. They received 80 mg XPOVIO maintenance therapy taken once daily or placebo up to disease progression.
SENDIO Study had targeted enrolment of 248 patients
The SENDIO study anticipated enrolling around 248 patients, and the study’s primary endpoint was progression-free survival to show a hazard ratio of 0.6. By the date of the futility analysis, the study had enrolled around 109 patients.
XPOVIO is the company’s first-in-class oral Selective Inhibitor of Nuclear Export product that selectively binds to and inhibits nuclear export protein exportin 1. The product functions by b blocking tumor suppressor growth, anti-inflammatory proteins, and growth regulators. These results in the accumulation of the proteins in the nucleus and thus enhance their anti-cancer activity. Protein retention can counteract several oncogenic pathways.