The European Myeloma Network and Karyopharm Announce Dosing of First Patient in Collaborative EMN29/XPORT-MM-031 Study

– Phase 3 Study Evaluating an All Oral Regimen of Selinexor in Combination with Pomalidomide and Low-dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma –

Excerpt from the Press Release:

ROTTERDAM, Netherlands and NEWTON, Mass., May 25, 2022 /PRNewswire/ — The European Myeloma Network (EMN), an international collaborative network of expertise centers for multiple myeloma in Europe and Australia, and Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the dosing of the first patient in the collaborative EMN29/XPORT-MM-031 study, a randomized, global Phase 3 study evaluating an all-oral regimen of selinexor, Karyopharm’s first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with Pomalyst® (pomalidomide) and low-dose dexamethasone (SPd) versus Empliciti® (elotuzumab), pomalidomide, and dexamethasone (EPd) in patients with relapsed or refractory multiple myeloma (NCT05028348//EMN29).

The Phase 3, two-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy, safety, and the impact on health-related quality of life of SPd versus EPd in pomalidomide-naïve patients with relapsed or refractory multiple myeloma. Patients will have received one to four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody (mAb), prior to being enrolled in the study. Final dosing for the selinexor arm at 40 mg or 60 mg will be determined following an interim analysis of data from the first 60 patients. The primary endpoint of the study is progression-free survival (PFS). The study is sponsored by the European Myeloma Network and is expected to recruit approximately 280 patients.

“Despite the progress made in treating multiple myeloma, new treatment options remain a critical need as the majority of patients will relapse and eventually stop responding to current therapies,” said Reshma Rangwala, MD, PhD, Chief Medical Officer at Karyopharm Therapeutics. “We look forward to collaborating with the EMN on this important study. We have encouraging data in patients who have been treated with an anti-CD38 based regimen and we are eager to see the result in this patient population.”

“We are extremely pleased to have this important study underway and look forward to further elucidating the potential of the SPd triplet regimen for Multiple Myeloma patients,” added Professor Katja Weisel, Deputy Director of the University Cancer Center in Hamburg (UCCH) and principal investigator of the EMN29/XPORT-MM-031 study. “We look forward to the top-line results in 2024.”

The initiation of this Phase 3 study follows encouraging data from an all-oral arm of the Phase 1b/2 STOMP study (NCT02343042) and the Phase 2 study XPORT-MM-028 (NCT04414475) in which selinexor was evaluated in combination with Pomalyst® and low-dose dexamethasone in patients with relapsed or refractory multiple myeloma who received at least two prior lines of therapy, including a PI and an IMiD.

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