On June 23, 2017 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers, reported the presentation today of updated clinical data from Stages 1 and 2 of the ongoing SL-401 pivotal Phase 2 clinical trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN), along with safety data from the entire SL-401 clinical program, at the 22ndCongress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held in Madrid, Spain (Press release, Stemline Therapeutics, JUN 23, 2017, View Source [SID1234519681]). Schedule your 30 min Free 1stOncology Demo! A summary of the presentation is as follows:
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Stages 1 and 2 enrolled 32 BPDCN patients, of which 19 were first-line and 13 patients were relapsed/refractory.
Median age was 72 years (range 29-85 years).
The most common treatment-related adverse events (TRAEs) with SL-401 across BPDCN and other indications (n=134 patients) were hypoalbuminemia (43%), transaminitis (43%), and thrombocytopenia (26%), by investigator-assessment. TRAEs included capillary leak syndrome (18%), of which 3 cases were grade 5 (2.2%), as previously reported.
The overall response rate (ORR) for Stage 1 and 2 BPDCN patients (n=32) was 84%, with a complete response (CR) rate of 59%, by investigator-assessment.
Eight BPDCN patients who achieved remission on SL-401 (for ~2.5 to ~6 months duration) were subsequently bridged to stem cell transplant, including one relapsed/refractory patient.
In first-line BPDCN patients treated at 12 ug/kg/day (n=16), the median overall survival (OS) has not been reached.
The full presentation will be available on the Stemline website (www.stemline.com), under the "Scientific Presentations" tab, following delivery of today’s presentation at EHA (Free EHA Whitepaper).
Stage 3 is fully enrolled (n=13 first-line BPDCN patients) and data will be reported, along with further updated Stage 1 and 2 data, in 2H17. Depending on the results of this ongoing Phase 2 trial, the largest prospective study ever conducted in this indication (n=45 patients), we intend to file a BLA for SL-401 in BPDCN in 4Q17/1Q18.