Karyopharm Therapeutics Inc. ( KPTI Quick Quote KPTI - Free Report) announced that the FDA has approved a label expansion of its marketed drug, oral Xpovio (selinexor), three months ahead of the target date. The drug in combination with Takeda’s ( TAK Quick Quote TAK - Free Report) Velcade (bortezomib) and dexamethasone received approval as a treatment for multiple myeloma (“MM”) in patients who have received at-least one prior therapy.
The drug is already approved in combination with dexamethasone for treating MM patients 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 approval of the drug for treating MM in the second-line setting should expand the drug’s patient population significantly. The oral administration of the drug will likely boost its demand in this patient population.
The oral drug received accelerated approval from the FDA for treating relapsed or refractory diffuse large B-cell lymphoma in the third-line setting in June.
The company plans to launch the drug immediately for second-line MM treatment. The company’s marketing authorization application (“MAA”) seeking approval for fourth-line MM indication is under review in Europe. The company plans to file another MAA by year-end for the second-line setting.
Shares of Karyopharm were up 8.4% on Dec 18 following the news. However, the company’s shares have lost 14.1% so far this year against the
industry’s growth of 3.4%.
The approval was based on data from the pivotal study — BOSTON — which compared the once-weekly dosage of Xpovio in combination with Velcade and dexamethasone to twice-weekly Velcade and dexamethasone regimen alone for efficacy, safety and certain health-related quality of life parameters. Data from the study showed that the addition of Xpovio to Velcade and dexamethasone improved progression-free survival (“PFS”) by 47%. Median PFS was 13.9 months in the Xpovio arm compared to 9.5 months in the comparator arm.
Moreover, a significantly higher overall response of 76% was achieved in the Xpovio arm and patients’ clinic visits were reduced by 35%. The patients also received 40% less bortezomib and 25% less dexamethasone due to fewer drug administrations per week. Peripheral neuropathy rates were also significantly lower for the Xpovio regimen. Detailed data from the BOSTON study had been published in
The company is also evaluating the drug in several other mid-and later-stage clinical studies across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies in liposarcoma and endometrial cancer. The company initiated a phase I/II study in combination with standard-of-care therapy in patients with newly-diagnosed or recurrent glioblastoma in June. It is also evaluating a low dose of the drug in a phase II study in hospitalized patients with severe COVID-19.
Apart from Xpovio, the company has three other pipeline candidates — eltanexor, verdinexor and KPT-9274. While verdinexor is being developed for treating viral, rare disease and autoimmune indications, eltanexor and KPT-9274 are being evaluated for treating myelodysplastic syndrome and hematologic or solid tumors, respectively.
Zacks Rank & Stocks to Consider
Karyopharm currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks worth considering in the same sector include
Bellicum Pharmaceuticals ( BLCM Quick Quote BLCM - Free Report) and Ironwood Pharmaceuticals ( IRWD Quick Quote IRWD - Free Report) , both carrying Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Bellicum’s loss per share estimates have narrowed 73.8% for 2021 over the past 60 days.
Ironwood earnings estimates have been revised higher 23.7% for 2021 over the past 60 days.
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