Shots:

• The P-III (SIENDO/ENGOT-EN5/GOG-3055) study evaluates Selinexor (80mg, qw) vs PBO in a ratio (2:1) in 263 patients with EC
• The study met its 1EPs i.e., 50% improvement in m-PFS (5.7mos. vs 3.8mos.), 30% reduction in risk of disease progression or death & showed a sustained & long-term improvement @12mos. with a 37% increase in probability, well-tolerated with no new safety signals & a 10.5% low discontinuation rate due to AEs. In a pre-specified subgroup, m-PFS (13.7mos. vs 3.7mos.) in patients with wild-type p53
• The company will submit sNDA to the US FDA & results in H1’22 at upcoming meetings. Selinexor is evaluated in other trials across multiple cancer indications including myelofibrosis

Ref: Karyopharm | Image: Karyopharm