Stemline Therapeutics’ SL-401 Phase 2 BPDCN Data Delivered Via Oral Presentation at ASH; High Response Rates Maintained Acr...
December 05 2016 - 12:48PM
Stemline Therapeutics, Inc. (Nasdaq:STML) announced today the oral
presentation of positive clinical data from its ongoing SL-401
Phase 2 potentially pivotal clinical trial in blastic plasmacytoid
dendritic cell neoplasm (BPDCN). The trial results were delivered
via an oral presentation by Naveen Pemmaraju, M.D., from the
University of Texas MD Anderson Cancer Center, on Sunday morning at
the 2016 American Society of Hematology (ASH) Annual Meeting, being
held at the San Diego Convention Center in San Diego, CA.
The full presentation is now available on the Stemline website,
under the “Scientific Presentations” tab (see link:
http://www.stemline.com/scientific-presentations.asp).
The Phase 2 BPDCN data presented at ASH cover 32 evaluable adult
BPDCN patients treated with SL-401. Results demonstrated that
SL-401 produced a 100% (16/16) overall response rate (ORR),
including an 81% (13/16) complete response (CR) rate in first-line
BPDCN patients treated at the recommended dose of 12 ug/kg/day and
a 95% (18/19) ORR in first-line patients treated at the recommended
dose or lower. In relapsed/refractory patients, the ORR was 69%
(9/13) with a CR rate of 31% (4/13). See Tables 1 and 2 for a
summary of efficacy and safety.
Response duration data continue to appear promising, with 69%
(11/16) first-line BPDCN patients treated at 12 ug/kg/day remaining
relapse-free (range: 1+ to 20+ months, ongoing). This includes four
patients receiving SL-401 therapy (range: 1+ to 15+ months,
ongoing), six patients in durable remission from SL-401 who were
then successfully bridged to stem cell transplant (SCT) and remain
in remission (range: 5+ to 20+ months progression-free after first
SL-401 dose), and one additional patient undergoing SCT
preparation. In the relapsed/refractory setting, 46% (6/13)
patients are relapse-free (range: 1+ to 7+ months). This includes
five patients receiving SL-401 therapy (range: 1+ to 4+ months,
ongoing) and one patient in durable remission from SL-401 who was
then successfully bridged to SCT and remains in remission for
approximately 8+ months, ongoing. The median progression-free and
overall survival for first-line has not been reached and for
relapsed/refractory it is currently 8.5 months.
Naveen Pemmaraju, M.D., Assistant Professor, Department of
Leukemia at the University of Texas MD Anderson Cancer Center
(Houston, TX), an investigator on the study, commented, “The
encouraging results generated to date with SL-401 continue to
indicate the agent could very well emerge as the standard of care
for both first-line and relapsed/refractory BPDCN, a devastating
disease for which there had previously been no effective therapy.
In addition to strong clinical activity, manifested by high levels
of durable responses, the safety profile with SL-401 continues to
be predictable and manageable over increasing patient experience.”
Dr. Pemmaraju continued, “Together with Stemline, we are working to
bring this promising new agent to patients as expeditiously as
possible in BPDCN and other malignancies.”
Andrew A. Lane, M.D., Ph.D., Assistant Professor, Medical
Oncology at the Dana-Farber Cancer Institute (Boston, MA), and a
co-investigator on the study, commented, “The clinical outcomes
seen with SL-401 in first-line and relapsed/refractory BPDCN
continue to be exciting, particularly given that these are two
greatly under-served patient populations. SL-401 has also begun to
show early promising signs in other clinical settings.” Dr. Lane
continued, “We are very pleased to be ongoing contributors to this
study, and look forward to helping to advance this active agent in
BPDCN and other hematologic malignancies as well.”
Table 1. SL-401 Summary of Clinical
Efficacy
Line of Therapy |
First-line |
First-line |
R/R |
All lines |
Dose Group |
All Doses |
12 ug/kg |
12 ug/kg |
All Doses |
n (evaluable/total) |
19 |
16 |
13 |
32 |
ORR |
18/19 (95%) |
16/16 (100%) |
9/13 (69%) |
27/32 (84%) |
CR*, n (rate) |
14 (74%) |
13 (81%) |
4 (31%) |
18 (56%) |
Bridged to SCT, n |
6 |
6 |
1 |
7 (22%) |
(allo+auto) |
(3+3) |
(3+3) |
(1+0) |
(4+3) |
*CR includes CRi (CR with incomplete hematopoietic recovery) and
CRc (CR in non-skin organs and gross reduction in cutaneous lesions
with residual microscopic disease).
Table 2. Most Common Adverse Events (≥ 15%
treatment-related adverse effects, TRAEs)
|
All Grades (% of patients) |
Grade ≥ 3 (% of patients) |
TRAEs |
All AEs |
TRAEs |
All AEs |
Transaminase elevation |
52 |
60 |
40 |
42 |
Hypoalbuminemia |
39 |
42 |
0 |
0 |
Chills |
31 |
35 |
0 |
0 |
Pyrexia |
27 |
42 |
0 |
0 |
Nausea |
23 |
46 |
0 |
0 |
Fatigue |
23 |
42 |
0 |
8 |
Thrombocytopenia |
19 |
19 |
19 |
19 |
Hypotension |
19 |
19 |
0 |
0 |
Weight increased |
19 |
27 |
0 |
0 |
Capillary leak syndrome (CLS) |
19 |
19 |
8 |
8 |
Anemia |
19 |
31 |
11 |
15 |
Decreased appetite |
19 |
23 |
0 |
0 |
Edema peripheral |
23 |
46 |
0 |
0 |
About Stemline TherapeuticsStemline
Therapeutics, Inc. is a clinical stage biopharmaceutical company
developing novel oncology therapeutics. Stemline is developing
three clinical stage product candidates, SL-401, SL-801, and
SL-701. SL-401 is a targeted therapy directed to the interleukin-3
receptor (CD123) present on a wide range of malignancies. SL-401 is
being advanced through a potentially pivotal Phase 2 trial in
patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN),
an indication for which SL-401 has been granted Breakthrough
Therapy Designation (BTD) by the FDA. SL-401 has demonstrated high
overall response rates (ORR), with multiple complete responses
(CRs), in both first-line and relapsed/refractory patients, and
treatment duration and frequency of bridge to transplant have been
trending favorably. SL-401 is also being advanced through Phase 1/2
trials of patients with additional malignancies including acute
myeloid leukemia (AML) in remission with minimal residual disease
(MRD), high-risk myeloproliferative neoplasms (MPN), and
relapsed/refractory multiple myeloma (in combination with
pomalidomide). SL-801 is a novel oral small molecule reversible
inhibitor of XPO1 that has demonstrated broad in vivo and in vitro
preclinical activity in a wide array of solid and hematologic
malignancies. A Phase 1 trial with SL-801 is open and enrolling
patients with advanced solid tumors, and a Phase 1 trial in
hematologic malignancies is planned. SL-701 is an immunotherapy
designed to activate the immune system to attack tumors. A Phase 2
trial with SL-701 in adult patients with second-line glioblastoma
multiforme (GBM) is ongoing. For more information about Stemline
Therapeutics, please visit www.stemline.com.
Forward-Looking StatementsSome 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, internal review board
approval, scientific review committee approval, patient accrual,
safety, tolerability and efficacy data observed, and input from
regulatory authorities; our plans to develop and commercialize our
product candidates; 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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