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Karyopharm posts positive data from Phase III trial of multiple myeloma drug

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A company that last year won accelerated Food and Drug Administration approval for a drug to treat multiple myeloma patients who have received numerous prior therapies will seek to expand its label on the back of a successful Phase III study.

Newton, Massachusetts-based Karyopharm Therapeutics said Monday that the Phase III BOSTON study of Xpovio (selinexor) combined with Takeda Pharmaceutical’s Velcade (bortezomib) and the steroid dexamethasone was successful in myeloma patients who had received one to three prior therapies. Median progression-free survival (PFS) in the arm of patients receiving Xpovio with once-weekly Velcade plus dexamethasone – also known as Vd – was 13.9 months, compared with 9.5 months among those receiving Vd alone.

Karyopharm’s shares were up by as much as 74% on the Nasdaq during midday trading Monday following the news. The company plans to submit the data for presentation at upcoming medical meetings. Near-future meetings dealing with oncology include the American Association of Cancer Research’s annual meeting in late April and the American Society of Clinical Oncology’s meeting in late May and early July.

In a statement, Karyopharm Chief Scientific Officer Sharon Shacham said the company plans also to submit a supplemental new drug application seeking to expand Xpovio’s label into second-line treatment of multiple myeloma.

The drug received accelerated approval in July of last year for so-called “penta-refractory” patients, meaning those whose disease is refractory to two proteasome inhibitors – a class that includes Velcade as well as Takeda’s Ninlaro (ixazomib) and Amgen’s Kyprolis (carfilzomib) – two immunomodulating drugs and one CD38-targeting monoclonal antibody. Bristol-Myers Squibb makes three immunomodulating drugs used to treat myeloma: Thalomid (thalidomide), Revlimid (lenalidomide) and Pomalyst (pomalidomide). Johnson & Johnson’s Darzalex (daratumumab) is an approved CD38-targeting monoclonal antibody, while Sanofi’s Sarclisa (isatuximab-irfc) won approval Monday.

Patients with penta-refractory disease are expected to live only three to five months if their disease is left untreated. Multiple myeloma is considered an incurable disease, meaning that patients have a constant need for new therapies.

The new data also may provide an opportunity to vindicate a drug whose accelerated approval attracted controversy. At the time, some experts saw the FDA’s decision as premature and said they would not use the drug unless they saw data from randomized, controlled trials. Others called it a “poster child” for what’s wrong with what they saw as the agency’s excessively “liberal” approach to oncology drug approvals.

Photo: FotografiaBasica, Getty Images

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