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Karyopharm doses first patient in Phase IIb trial of selinexor to treat DLBCL

Karyopharm Therapeutics has dosed the first patient in a registration-directed Phase IIb trial (SADAL) of its lead drug candidate Selinexor (KPT-330) to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have also granted orphan drug designation for selinexor to treat patients with DLBCL.

The Phase IIb trial will evaluate the safety and efficacy of 100mg versus 60mg Selinexor in combination with 8-12mg dexamethasone for supportive care, in these patients.

According to the company, the trial would take about two years to complete and is expected to support accelerated regulatory approval.

Karyopharm president and chief scientific officer Sharon Shacham said: "This study in DLBCL is the third registration-directed study initiated for Selinexor this year.

"In June we initiated a registration-directed study evaluating Selinexor in patients with acute myeloid leukemia and in November we initiated a registration-directed study evaluating Selinexor in patients with Richter’s Transformation.

"We are very encouraged by the responses and durability demonstrated to-date in patients with DLBCL and look forward to continuing to evaluate Selinexor in this patient population.

"Our goal is to accelerate development of Selinexor in severe hematologic indications with great unmet need while simultaneously broadening the scope of our development efforts in other hematologic and solid tumor indications."