Karyopharm Therapeutics Inc. (NASDAQ: KPTI) has offered an update on its engagement with the US FDA about the previously anticipated supplemental New Drug Application submission based on data from the third phase SIENDO trial assessing selinexor as first-line maintenance therapy after chemo in individuals with recurrent or advanced endometrial cancer. The study enrolled 263 participants with primary recurrent or stage IV disease that has complete or partial response after 12 weeks.
Karyopharm to launch a study evaluating selinexor in advanced endometrial cancer
Following discussions with the FDA, Karyopharm intends to launch a new randomized, placebo-controlled study of selinexor in the recurrent or advanced endometrial cancer p53 wild-type demographic to endorse a prospective sNDA submission as the prevailing topline findings from the SIENDO trial is unlikely to endorse sNDA approval. Accordingly, the company will initiate the study and work with the regulatory agency and established partners such as Gynecologic Oncology Group Foundation Inc. (GOG-F) and the European Network of Gynaecology Oncological Trip groups (ENGOT).
Chief Scientific Officer Sharon Shacham said, “We strongly believe in selinexor’s potential in patients with p53 wild-type and are excited to further evaluate it in this patient population to better understand its potential to address the unmet need in women with endometrial cancer.”
The SIENDO p53 Wild-Type findings Inspire Karyopharm, and the company is determined to work with the FDA to plan and launch a new study. This year’s focus was on the patient group for whom Selinexor might have the most promise.
P53 wild-type endometrial cancer has limited treatment alternatives
Most endometrial malignancies are detected early and treated with surgery. Nevertheless, individuals with advanced and recurring endometrial cancer have extremely limited treatment options after first-line treatments, and their prognosis is often poor. Selinexor could potentially change the way people with p53 wild-type endometrial cancer are treated,
Karyopharm will discuss the SIENDO findings in mid-March at ESMO’s Virtual Plenary on March 17, 2022, and at the Society for Gynecologic Oncology’s 2022 Annual Meeting, which will take place March 18-21, 2022.