Nexpovio Triple Combo Approved as Myeloma Treatment in Europe
The European Commission has granted full approval to a triple combination therapy of Nexpovio (selinexor) — sold in the U.S. as Xpovio — to treat adults with multiple myeloma who have received at least one previous line of therapy.
The approval covers Nexpovio in combination with Velcade (bortezomib) and low-dose dexamethasone, a corticosteroid.
It is valid in all 27 member states of the EU as well as Iceland, Liechtenstein, Norway, and Northern Ireland.
Nexpovio, developed by Karyopharm Therapeutics, previously had been under conditional approval for patients with myeloma who had at least four previous treatments. Such conditional approval is granted to a medication that fulfills an unmet medical need when the therapy’s preliminary benefits are found to outweigh its potential risks. Further testing and data are normally required for full approval.
“The European Commission’s approval of an expanded use of Nexpovio provides another option for patients with multiple myeloma who have relapsed, or become resistant to current treatment regimens,” Richard Paulson, president and CEO of Karyopharm, said in a press release.
The triple combo will be commercialized in Europe by Stemline Therapeutics, a wholly owned subsidiary of the Menarini Group.
“The approval of Nexpovio marks an important step forward for patients in Europe where nearly 51,000 new cases of multiple myeloma are diagnosed each year and therapeutic options are limited” said Elcin Barker Ergun, CEO of Menarini.
“We are committed to offering patients and physicians a valuable new treatment option and are working hard to make Nexpovio available in different European countries as quickly as possible,” Ergun said.
The expanded approval was supported by data from a Phase 3 clinical trial called BOSTON (NCT03110562), launched in 2017.
The trial involved 402 adults with multiple myeloma whose cancer had returned or progressed despite one to three prior lines of treatment. The participants were randomly assigned to treatment with Nexpovio plus Velcade and dexamethasone, or to Velcade and dexamethasone only.
Results showed that patients given the Nexpovio combo had significantly longer median progression-free survival times. Specifically, adults taking the full combination had progression-free survival of 13.93 months compared with 9.46 months for those on just Velcade and dexamethasone — representing a 4.47 month or 47% increase with Nexpovio.
The overall response rate was significantly higher in the Nexpovio group (76.4% vs. 62.3%), and other measures of treatment response also generally favored those given the full combination.
Nexpovio is designed to block the activity of a protein called XPO1 that helps cancer cells grow. Outside Europe, the therapy is marketed under the name Xpovio.
In the U.S., the triple-combination therapy with Velcade and low-dose dexamethasone was approved in late 2020 to treat myeloma patients with one prior line of therapy.
“Our decision to pursue approval for this patient population is indicative of our commitment to expand access to selinexor across the globe and we look forward to working closely with Menarini who will commercialize Nexpovio in Europe,” Paulson said.