Karyopharm Therapeutics Inc. (NASDAQ:KPTI) reported impressive results on December 1, 2018 for its lymphoma drug candidate Selinexor, noting patients who experienced a complete or partial response in a 125-patient trial had a median overall survival rate of 29.7 months.
Previously published survival had established a life expectancy of less than 7 months for the relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients treated in the phase IIb study.
After announcing the results on Saturday, in accordance with the protocol of the scientific conference, Karyopharm shares are likely to be active on Monday, both in pre-market and daily market trading. The results from the study are consistent with a previous Karyopharm study of Selinexor in May, which resulted in an increase to approximately $20 per share from about $13 per share prior to the announcement of the results.
Another SanaCurrents-tracked company, Eidos Therapeutics, Inc. (NASDAQ:EIDX), released clinical results on Saturday, November 10; Eidos shares closed November 9 at $12.71 per share. At close of trading on Monday, November 12, EIDX traded at $14.60 after approaching $15 per share during the day.
Based on Saturday’s results, Karyopharm affirmed it planned to submit a new drug application (NDA) to the FDA in the first half of 2019 to seek approval for Selinexor in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma (NHL).
Despite being considered an aggressive and fast-growing lymphoma, DLBCL is curable if caught early enough. However if the disease does not respond to the initial treatment and enters stage III or IV, the patients’ options are limited. Selinexor treated late-stage patients in the phase IIb study named SADAL (Selinexor Against Diffuse Aggressive Lymphoma).
Stem cell transplants are available for DLBCL patients, but most late-stage DLBCL patients are not healthy enough to undergo the procedure. As a result, the life expectancy for this patient population is usually less than 12 months.
In the phase IIb results announced Saturday, the median duration of response was 9.2 months in patients with a complete or partial response.
In the SADAL study’s primary endpoint, single-agent selinexor achieved a 29.6% overall response rate (ORR), which included a 9.6% complete response (CR) rate in patients with heavily pretreated relapsed or refractory DLBCL.
Selinexor has received Fast Track designation from the FDA for the patient population evaluated in the SADAL study. The NDA Karyopharm plans to submit next year will include a request for accelerated approval for oral single-agent selinexor as a new treatment for patients with relapsed or refractory DLBCL.