Phase 3 Cancer Study Results Published in The Lancet

A Massachusetts-based pharmaceutical company pioneering novel cancer therapies announced that the results of the Phase 3 BOSTON study evaluating XPOVIO in patients with relapsed or refractory multiple myeloma were published online in The Lancet on November 14, 2020.

Karyopharm Therapeutics Inc.’s sponsored BOSTON study evaluated once weekly XPOVIO, the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, in combination with once-weekly Velcade® (bortezomib) and low-dose dexamethasone against standard twice-weekly Velcade in adult patients with multiple myeloma who had received one to three prior lines of therapy.

"The results from the BOSTON study published in The Lancet demonstrated that the once-weekly regimen of XPOVIO and Velcade®, with low-dose dexamethasone (SVd) reduced the risk of disease progression or death by 30% and induced a higher rate of overall and deep responses compared to patients receiving a standard twice-weekly Velcade® and low-dose dexamethasone regimen (Vd),” said Dr. Paul Richardson, Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute and co-senior author of the manuscript, in a press release issued on November 12, 2020.

This was observed despite approximately 40% less Velcade®, 25% less dexamethasone, and approximately 35% fewer clinic visits on the SVd arm as compared with the standard Vd therapy arm.  

Encouragingly, the efficacy of the SVd regimen was consistent and noteworthy across several key subgroups, including patients who were frail or 65 years and older, patients with high-risk cytogenetics, patients with moderate renal impairment, and patients who had either prior bortezomib or lenalidomide treatment," 

"Despite the enrollment of 50% of patients with high-risk cytogenetics, a particularly difficult to treat population, the SVd regimen demonstrated a 47% improvement in progression-free survival as compared to the Vd regimen and an overall response rate of 76.4%. Additionally, the rate and severity of peripheral neuropathy, a key treatment-limiting side effect commonly seen with Velcade® therapy, was significantly lower on the SVd arm compared to the Vd arm and may lead to improved patient quality of life," added Sundar Jagannath, M.D., Director of the Center of Excellence for Multiple Myeloma and Professor of Medicine, Hematology and Medical Oncology, at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, and an investigator in the BOSTON study.

Once-weekly SVd is a novel, effective and convenient triplet therapy that utilizes approximately 40% less Velcade® and 25% less dexamethasone and requires approximately 35% fewer clinic visits during the first 24 weeks of treatment compared to the standard Vd regimen. Because Velcade® is given as a subcutaneous injection rather than as an infusion, clinic visits may be shorter with the SVd regimen than with other non-Velcade® regimens that may be employed to treat relapsed multiple myeloma and require intravenous infusions.

According to the National Cancer Institute (NCI), multiple myeloma is one of the most common types of blood cancer in the U.S. with more than 32,000 new cases each year and over 140,000 patients living with the disease. It is most frequently diagnosed among people aged 65-74 years old. 

Despite recent therapeutic advances, there is currently no cure and most patients' disease will typically progress following treatment with currently available therapies. According to the NCI, nearly 13,000 deaths due to multiple myeloma are expected in the U.S. in 2020.

Additional clinical trial information for selinexor is available at ClinicalTrials.gov

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