BAC. On kpti
?Encouraging NHL data, especially DLBCL
At an oral presentation on Saturday KPTI provided data from 43 evaluable patients from its phase 1 dose escalation study for its first in class oral selective inhibitor of nuclear transport (SINE) candidate Selinexor in patients with heavily pre-treated Non-Hodgkin’s Lymphoma (NHL). Single-agent anti-tumor activity was observed across all evaluated NHL subtypes. In DLBCL, one complete response (CR) and nine stable disease (SD) responses were observed. Grade 3/4 non-DLT adverse events (AEs) included thrombocytopenia (20%), neutropenia (16%) and hyponatremia (6%). The company will likely choose the 60mg/m2 BIW for its phase 2/3 trial. We maintain our Buy rating and $48 PO on KPTI shares given our view that Selinexor’s broad applicability across multiple indications beyond NHL, thus far benign safety profile and large phase 1 study (300+ patients) positions the company well relative to other early stage oncology companies.
Particularly strong results in difficult to treat patients
In patients with heavily pretreated DLBCL disease response and control data in a hard to treat subgroup (called ‘double hit’, expressing oncoproteins MYC and BCL2 or BCL6) were in our view quite strong. In the four double hit DLBCL patients, there was one CR, two patients with SD (43% and 45% lymph node reductions), and one progressive disease.
Favorable survival data in AML patients
In a poster session on Saturday, response data from 63 AML patients treated with Selinexor (including 16 patients who did not complete the first cycle of treatment) were presented. Five patients showed CRs while 21 showed stable disease. Grade 3/4 non-dose limiting toxicity (DLT) AEs included fatigue (18%), thrombocytopenia (15%), neutropenia (11%), and nausea (8%). The most common Grade 1/2 AEs were diarrhea (82%), anorexia (78%), nausea (74%), and fatigue (65%). There were no drug-associated deaths. Higher doses of Selinexor were associated with greater reductions in bone marrow blast counts, which were also observed across different AML subtypes. The company will use the 55mg/m2 dose for phase 2/3 in AML. We expect additional data for AML at the EHA meeting later this month.
?Estimates (Dec) (US$)
AI
