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Selinexor plus dexamethasone appears active in heavily pretreated myeloma
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The addition of selinexor and low-dose dexamethasone appeared active in patients with heavily pretreated multiple myeloma, according to study results released by the agent’s manufacturer.
The single-arm, phase 2b STORM study evaluated selinexor (KPT-330, Karyopharm Therapeutics) — an oral selective inhibitor of nuclear export (SINE) compound —with low-dose dexamethasone in 78 heavily pretreated patients with multiple myeloma. The cohort included patients with quad-refractory disease (n = 48) or penta-refractory disease (n = 30).
Researchers reported an overall response rate of 20.5%. They reported ORRs of 20.8% among patients with quad-refractory disease and 20% among those with penta-refractory disease.
The side effect profile of selinexor appeared consisted with that observed in prior trials, and investigators identified no new safety signals.
“Although treatment of multiple myeloma has improved dramatically, eventually many patients will develop refractory disease, no longer responding to any of the immunomodulatory agents and proteasome inhibitors commonly used,” Keith Stewart, MB, ChB, professor of cancer research at Mayo Clinic and lead investigator of the STORM study, said in a press release. “These patients will also eventually progress on anti-CD38 monoclonal antibodies, which we refer to as penta-refractory disease. These are clearly the patients with the highest unmet need, as they have no remaining viable treatment options.”
Stewart called the STORM data “compelling.”
“We are currently unaware of any other therapy, oral or intravenous, reporting such activity in these difficult-to-treat patients who have exhausted all available therapies,” he said.
The phase 1b/phase 2 STOMP study has been initiated to evaluate selinexor in combination with existing therapies — including bortezomib (Velcade, Takeda) and dexamethasone — across a broader population of patients with multiple myeloma.
“Our updated clinical development plan for selinexor in myeloma reflects the strong foundation of clinical data from both the STORM and STOMP studies,” Michael G. Kauffman, MD, PhD, CEO of Karyopharm, said in the press release. “We believe this development plan provides a path to potential FDA and EMA filings for oral selinexor in multiple myeloma, with the potential to support accelerated or conditional approval if the FDA or EMA, respectively, agree. We look forward to sharing the additional data from both STORM and STOMP later this year. We believe selinexor has the potential to be a much-needed oral treatment option for patients suffering with this incurable disease.”