Stemline Therapeutics Presents SL-401 Updated Stage 1 and 2 Data from Ongoing Pivotal Trial in BPDCN and Safety Experience Across Multiple Indications, Today at EHA
A summary of the presentation is as follows:
- 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.
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.
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially include: the success and timing of our clinical trials and preclinical studies for our product candidates, including site initiation, institutional review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities including the risk that the
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