Karyopharm unveils positive results from Phase 3 BOSTON study
Category: #health  By Saipriya Iyer  Date: 2020-03-03
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Karyopharm unveils positive results from Phase 3 BOSTON study

Karyopharm Therapeutics Inc., an innovation driven pharmaceutical company, has reportedly announced positive top-line results from its randomized Phase 3 BOSTON study assessing once-weekly XPOVIO® (selinexor) coupled with once-weekly Velcade® and low dose dexamethasone (SVd) in comparison to conventional twice-weekly Velcade and low-dose dexamethasone (Vd) regimen in patients suffering from multiple myeloma that have undergone one to three prior lines of therapy.

The BOSTON study met its main endpoint of a statistically substantial rise in PFS (progression-free survival). The median PFS in the SVd arm was 13.93 months as compared to 9.46 months in the Vd arm, demonstrating a 4.47 month increase in median PFS.

No novel safety signals were found on the SVd arm and no imbalance in deaths between the two arms in the study occurred. The top-line information would be presented for presentation at upcoming medical meetings.

Sharon Shacham, President and Chief Scientific Officer, Karyopharm, stated that the company is thrilled to report these extremely significant top-line outcomes from the BOSTON study, the very first randomized Phase 3 trial to showcase statistically and clinically noteworthy activity of once-weekly XPOVIO combined with a current standard of care treatment in patients suffering from myeloma after one to three previous therapies.

Shacham further stated that in the study, patients in the SVd treatment lived 47% longer without their disease taking a turn for the worse, which the company believes represented an improvement in the treatment of patients with refractory or relapsed multiple myeloma. The company is further planning to submit the complete data set for presentations at the coming medical meetings to share the results with the medical community.

The company is also intending to submit the data to the U.S. FDA as soon as possible as part of a supplemental New Drug Application in order to expand the approved indication for XPOVIO into second line treatment for patients with refractory or relapsed multiple myeloma. If the treatment is accepted, the SVd regimen would be the first as well as only FDA-affirmed combination drug regimen including once-weekly Velcade therapy for relapsed myeloma.

XPOVIO received approval on July 3, 2019 from the FDA for treating adult patients diagnosed with refractory or relapsed multiple myeloma that had received up to four earlier therapies with their disease being refractory to an anti-CD38 monoclonal antibody, two immunomodulatory agents, and two proteasome inhibitors as well.

Source credit: https://investors.karyopharm.com/news-releases/news-release-details/karyopharm-announces-phase-3-boston-study-meets-primary-endpoint



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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