- Oops!Something went wrong.Please try again later.
Karyopharm Therapeutics Inc. KPTI announced that it has dosed the first patient in a phase I/II study evaluating its oral XPO1 inhibitor, Xpovio (selinexor), in combination with standard-of-care therapy in patients with newly-diagnosed or recurrent glioblastoma (GBM).
Xpovio is currently available in higher doses to treat relapsed or refractory multiple myeloma.
This phase I/II study (XPORT-GBM-029/NCT04421378) will be conducted in two phases. It will consist of a phase I dose-finding study, followed by a phase II efficacy exploration study. The phase II portion will evaluate three different regimens — Xpovio in combination with radiation therapy, with or without the addition of temozolomide, and Xpovio in combination with lomustine.
The study’s primary endpoints are progression-free survival in patients with newly-diagnosed GBM and overall survival in patients with recurrent GBM.
Though Xpovio has been most extensively studied in patients with hematologic malignancies, the drug has also demonstrated that it may play an important role in the treatment of a variety of solid tumors, including patients with GBM. In a phase II KING study, which evaluated Xpovio as a single agent in patients with recurrent GBM, the candidate demonstrated clear anti-cancer activity. Hence, the company is optimistic about assessing Xpovio’s activity in combination with the currently used standard-of-care treatments.
Karyopharm also submitted two additional supplemental new drug applications for Xpovio, which are currently under review with the FDA for a label expansion to include patients with multiple myeloma after at least one prior line of therapy and the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Shares of Karyopharm have lost 6.4% so far this year compared with the industry’s decline of 4.4%.
Meanwhile, in April, the company began a phase II study to evaluate a lower dose of Xpovio in hospitalized patients with severe COVID-19.
Meanwhile, several marketed drugs like Sanofi,/Regeneron’s IL-6 inhibitor, Kevzara; Roche’s RHHBY IL-6 inhibitor, Actemra; Incyte/Novartis’ JAK1/JAK2 inhibitor, Jakafi; AstraZeneca’s AZN BTK inhibitor, Calquence; and Amgen’s AMGN PDE4 inhibitor, Otezla, among others, are being evaluated to treat respiratory complications associated with COVID-19, which is the need of the hour.
Karyopharm Therapeutics Inc. Price
Karyopharm Therapeutics Inc. price | Karyopharm Therapeutics Inc. Quote
Karyopharm currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases. Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
AstraZeneca PLC (AZN) : Free Stock Analysis Report
Roche Holding AG (RHHBY) : Free Stock Analysis Report
Amgen Inc. (AMGN) : Free Stock Analysis Report
Karyopharm Therapeutics Inc. (KPTI) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research