Stemline Therapeutics Presents SL-401 Updated Stage 1 and 2 Data from Ongoing Pivotal Trial in BPDCN and Safety Experience Ac...
June 23 2017 - 09:36AM
Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage
biopharmaceutical company developing novel therapeutics for
difficult to treat cancers, announced 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 22nd Congress of the European
Hematology Association (EHA) being held in Madrid, Spain.
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.
About Stemline Therapeutics Stemline
Therapeutics, Inc. is a clinical stage biopharmaceutical company
developing novel therapeutics for difficult to treat cancers. A
Phase 2 pivotal trial with SL-401, a targeted therapy directed to
the interleukin-3 receptor (CD123), has completed enrollment of
patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN)
in the Stage 3 cohort, and patients continue to be treated and
followed. SL-401 has been granted Breakthrough Therapy Designation
(BTD) for the treatment of BPDCN. Additional Phase 1/2 trials with
SL-401 are enrolling patients with other malignancies including
myeloproliferative neoplasms (MPN) (chronic myelomonocytic leukemia
[CMML] and myelofibrosis [MF]) and acute myeloid leukemia (AML) in
remission with minimal residual disease (MRD). A Phase 1/2 trial of
SL-401 in combination with pomalidomide is enrolling patients with
relapsed/refractory multiple myeloma. A Phase 1 dose escalation
trial with SL-801, a novel oral small molecule reversible inhibitor
of XPO1, is enrolling patients with advanced solid tumors. A Phase
2 trial with SL-701, an immunotherapy designed to activate the
immune system to attack tumors, has completed dosing and patients
with second-line glioblastoma are being followed for survival.
Forward-Looking Statements 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 FDA or other
ex-U.S. national drug authority ultimately does not approve any of
our product candidates; our plans to develop and commercialize our
product candidates; market acceptance of our products;
reimbursement available for our products; our available cash and
investments; our ability to obtain and maintain intellectual
property protection for our product candidates; our ability to
manufacture; the performance of third-party manufacturers, clinical
research organizations, clinical trial sponsors and clinical trial
investigators; and other risk factors identified from time to time
in our reports filed with the Securities and Exchange Commission.
Any forward-looking statements set forth in this press release
speak only as of the date of this press release. We do not intend
to update any of these forward-looking statements to reflect events
or circumstances that occur after the date hereof.
Contact
Investor Relations
Stemline Therapeutics, Inc.
750 Lexington Avenue
Eleventh Floor
New York, NY 10022
Tel: 646-502-2307
Email: investorrelations@stemline.com
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