Oncology-focused pharmaceutical company Karyopharm Therapeutics Inc. (KPTI:NASDAQ) today announced that it achieved "positive top-line results from the randomized Phase 3 BOSTON study evaluating once-weekly XPOVIO® (selinexor) in combination with once-weekly Velcade® (bortezomib) and low-dose dexamethasone (SVd) compared to standard twice-weekly Velcade plus low-dose dexamethasone (Vd) in patients with multiple myeloma who have received one to three prior lines of therapy."
The company reported that the BOSTON trial of XPOVIO successfully met its primary endpoint defined as a statistically significant increase in progression-free survival (PFS) in patients with multiple myeloma. The firm stated that the SVd arm achieved a 47% increase in median PFS and that no new safety signals were recorded.
Sharon Shacham, Ph.D., president and chief scientific officer of Karyopharm, commented, "We are thrilled to report these highly significant top-line results from the BOSTON study, the first randomized Phase 3 trial to demonstrate clinically and statistically significant activity of once-weekly XPOVIO in combination with a current standard of care treatment in patients with myeloma after one to three prior therapies...In the study, patients on the SVd regimen lived 47% longer without their disease worsening, which we believe represents an important improvement in the treatment of patients with relapsed or refractory multiple myeloma. We plan to submit the full data set for presentations at upcoming medical meetings to share the results with the medical community. We also intend to submit these data as quickly as possible to the U.S. Food and Drug Administration (FDA) as part of a supplemental New Drug Application seeking to expand the approved indication for XPOVIO into second line treatment for patients with relapsed or refractory multiple myeloma. If approved, the SVd regimen would be the first and only FDA-approved combination drug regimen that includes once-weekly Velcade therapy for relapsed myeloma."
The firm advised that "XPOVIO received accelerated approval from the FDA on July 3, 2019, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody."
The BOSTON Study is a Phase 3 randomized, multicenter study of approximately 402 patients in more than 150 clinical sites internationally.
The company explained that multiple myeloma is the second most common blood cancer in the U.S. with more than 32,000 new cases recorded annually for which at present there is no cure and that in the U.S nearly 13,000 deaths occurred in 2019 due to multiple myeloma.
Karyopharm Therapeutics is based in Newton, Mass., and describes its business as "an oncology-focused pharmaceutical company dedicated to the discovery, development, and commercialization of novel first-in-class drugs directed against nuclear export and related targets for the treatment of cancer and other major diseases."
Karyopharm Therapeutics began the day with a market capitalization of around $1.1 billion with approximately 65.55 million shares outstanding and a short interest of about 20.4%. KPTI shares opened 44% higher today at $23.52 (+$7.18, +43.94%) over Friday's $16.34 closing price and reached a new 52-week high price this morning of $29.61. The stock has traded today between $22.0 and $29.61 per share and is currently trading at $27.39 (+$10.05, +67.63%).[NLINSERT]
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