India Pharma Outlook Team | Wednesday, 01 November 2023
Karyopharm Therapeutics recently announced that it and Bristol-Myers Squibb have partnered on a clinical trial to assess the efficacy of mezigdomide, a proprietary investigational cereblon E3 ligase modulator (CELMoD) agent, in combination with selinexor, an approved first-in-class inhibitor of Exportin 1 (XPO1), plus dexamethasone in treating 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 (IMiD) drug agents, proteasome inhibitors, and anti-CD38 monoclonal antibody treatment.
All patients must have received at least two prior lines of therapy, and either have progressed after or are not eligible to receive CAR-T or bispecific antibody treatment, as per pharmabiz This trial's main goals are to evaluate the clinical benefit rate (CBR) and the objective response rate (ORR). Progression-free survival (PFS), overall survival (OS), and duration of response (DOR) are important secondary goals. Furthermore, when patients receive treatment, the experiment will assess dynamic changes in T-cell populations and activity. As per the terms of the agreement with Bristol Myers Squibb, mezigdomide, the study's clinical medication, will be supplied by Bristol Myers Squibb, and Karyopharm will fund the trial as a new arm of Karyopharm's phase 1b/2 STOMP trial. A pharmaceutical firm in the commercial stage, Karyopharm Therapeutics Inc. is developing cutting-edge cancer treatments. Since its establishment, Karyopharm has dominated the market for oral Selective Inhibitor of Nuclear Export (SINE) chemical technology. This technology was created to address nuclear export dysregulation, a key oncogenesis pathway.