Karyopharm signs clinical trial collaboration with Bristol Myers in myeloma

Karyopharm Therapeutics (KPTI) has entered into a clinical trial collaboration and supply agreement with Bristol-Myers (BMY) to evaluate the company’s proprietary investigational cereblon E3 ligase modulator agent mezigdomide in combination with Karyopharm’s selinexor, an approved first-in-class inhibitor of Exportin 1, plus dexamethasone in patients with relapsed/refractory multiple myeloma. This trial will evaluate mezigdomide in combination with selinexor doses of either 40mg or 60mg plus dexamethasone in patients who have prior exposure to immunomodulatory drug agents, proteasome inhibitors, and anti-CD38 monoclonal antibody treatment. The companies expect to initiate the trial in the first half of 2024. The primary endpoints of this trial are to assess the objective response rate and the clinical benefit rate. Key secondary endpoints include progression-free survival, overall survival and duration of response. In addition, the trial will evaluate dynamic changes in T-cell populations and activity as patients undergo treatment. Under the terms of the agreement with Bristol Myers Squibb, Karyopharm will sponsor the trial as a new arm of Karyopharm’s Phase 1b/2 STOMP trial and Bristol Myers Squibb will supply the study’s clinical drug mezigdomide.