An Expected Failure From Karyopharm's Selinexor Doesn't Change The Bull Thesis

Karyopharm Therapeutics Inc KPTI announced that the interim analysis of its Phase 2 SOPRA study of selinexor monotherapy in acute myelogenous leukemia (AML) failed to meet the primary endpoint of overall survival (OS).

Wedbush’s David M. Nierengarten maintaisd an Outperform rating on the company, with a price target of $14.

Trial Failure

The analyst mentioned that complete remission rates for selinexor was 13 percent, as compared to 3 percent in patients randomized on other supportive care.

“The higher response rates with selinexor, however, failed to translate to significant survival improvement; specific OS data was not provided, but we note target OS in control arm going-in was 3 months,” Nierengarten stated.

There Are Still Positives

In addition, the risk of sepsis as well as febrile neutropenia were found to be lower in patients treated with selinexor as compared to the control group.

Karyopharm Therapeutics reduced the dosage in 2015 due to increased risk of sepsis revealed early during the trial.

Related Link: Karyopharm Announces the Presentation of New Data at the 2017 American Association for Cancer Research Annual Meeting

The analyst believes this safety data should be able to dispel any remaining concerns regarding sepsis risk.

Data from the SADAL trial of selinexor in diffuse large B-cell lymphoma is expected at the AACR on April 4.

“The poster title suggests durable responses were observed with selinexor in both GCB- (germinal center B-cell) and non-GCB subtypes, which would mirror activity observed in Ph 1,” Nierengarten went on to say.

Key Differentiator

The analyst noted that the stronger action of selinexor in GCB was a key differentiator, since most currently recommended DLBCL agents have revealed weaker efficacy among GCB patients.

“We model for 1H19 approval, and believe that in the evolving treatment landscape for r/r DLBCL, selinexor would be attractively positioned as an oral therapy with a better risk-profile versus other emerging therapies like CAR-Ts,” Nierengarten added.

At last check in Friday's pre-market session, shares of Karyopharm Therapeutics were down 17.77 percent at $11.38.