- Published Data Highlights
Achievement of Myeloablation (Median Day 5) and Engraftment (Median
Day 12-13) with no mortality (Day 100)
- EVOMELA is Free of Propylene Glycol,
a Diluent Required for Reconstitution of Current Melphalan
Formulations that is Associated with Renal and Cardiac
Toxicities
- Increased Stability of EVOMELA
Allows Longer Use Time Facilitating Clinical Administration
Logistics
- On Track for PDUFA Decision on
October 23, 2015; Company Plans to Launch EVOMELA with Existing
Sales Force in a Market Estimated at Approximately $100
Million
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in Hematology and Oncology, today
announced publication of results from the pivotal clinical study
for EVOMELA, used for myeloablative conditioning in multiple
myeloma (MM) patients undergoing autologous transplantation.
(ASCT). The study, led by Dr. Parameswaran Hari from Froedtert
Hospital and Medical College of Wisconsin, was published in the
Biology of Blood and Marrow Transplantation (BBMT) journal.
“We are pleased to have these clinical data selected for
publication in the BBMT journal,” said Rajesh C. Shrotriya, MD,
Chairman and Chief Executive Officer of Spectrum Pharmaceuticals.
“These study data confirm the efficacy and acceptable safety
profile of EVOMELA as a high-dose conditioning regimen for ASCT in
patients with MM. Our novel EVOMELA formulation uses Captisol to
improve the solubility and stability of Melphalan, and has
eliminated the need for a propylene glycol-containing cosolvent.
Importantly, this allows for longer use and infusion times with
EVOMELA, which potentially simplifies its clinical use and
administration logistics. Instead of propylene glycol, which is
associated with toxicities including renal dysfunction and
arrhythmias, this new formulation uses a standard aqueous diluent
for reconstitution. We look forward to FDA’s NDA decision on
EVOMELA in October. Spectrum continues to deliver on its commitment
to develop improved cancer therapies that benefit patients and
health care providers."
The BBMT journal publication includes data on 61 patients who
were enrolled in this open-label Phase 2b pivotal study at five US
study sites; 56 patients had newly diagnosed disease and five had
relapsed MM following prior ASCT. Patients enrolled in this study
received 200 mg/m2 of EVOMELA as two doses on Day -3 and Day -2
prior to ASCT (Day 0). Efficacy was assessed by clinical response
at Day +100 with an ORR of 95% and CR rate of 31% (16% stringent
CRs) based on investigators’ assessments, and rates of 100% and
21%, respectively based on independent pathology review; the lower
rate of confirmed CRs in the independent review was due to missing
data. Importantly, the five patients who had previously relapsed
from a prior ASCT were all shown to achieve a response to EVOMELA.
All patients in the study achieved myeloablation with a median of 5
days post-ASCT, and all patients had successful neutrophil and
platelet engraftment (median of 12 days and 13 days post-ASCT,
respectively). Treatment-related mortality was 0%, and
non-hematologic adverse events were mostly Grade 1 and Grade 2 in
severity. The incidence of Grade 3 mucositis and Grade 3 stomatitis
were 10% and 5%, respectively with no Grade 4 mucositis or
stomatitis reported. Twenty percent of patients experienced
treatment-emergent serious adverse events, most of which were Grade
3, and consisted of events commonly reported in patients undergoing
myeloablative chemotherapy; no new safety signals were
identified.
In December 2014, Spectrum submitted an NDA to the FDA for the
approval of EVOMELA for use as a high-dose conditioning treatment
prior to ASCT in patients with MM. Spectrum is also seeking
approval for the palliative treatment of patients with MM for whom
oral therapy is not appropriate, which is the indication for the
currently approved IV melphalan products. The NDA was accepted and
a PDUFA decision is expected on October 23, 2015.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company
focused on acquiring, developing, and commercializing drug
products, with a primary focus in Hematology and Oncology. Spectrum
currently markets five hematology/oncology drugs, and expects an
FDA decision on another hematology drug later this year.
Additionally, Spectrum's pipeline includes three drugs targeting
blockbuster markets in advanced stages of clinical development.
Spectrum's strong track record for in-licensing and acquiring
differentiated drugs, and expertise in clinical development have
generated a robust, diversified, and growing pipeline of product
candidates in advanced-stage Phase 2 and Phase 3 studies. More
information on Spectrum is available at www.sppirx.com.
About Multiple Myeloma
Multiple Myeloma is a systemic malignancy of plasma cells that
accumulate in the bone marrow, usually associated with monoclonal
antibody secretion, and results in bone marrow failure and bone
destruction. It is the second most common hematologic disease with
nearly 27,000 new cases projected in the US in 2015 and over 11,000
deaths annually (American Cancer Society Stats, 2015). The rate of
ASCT for patients with multiple myeloma is growing by approximately
3.3% annually.
While MM is usually sensitive to cytotoxic chemotherapy, most
responses are transient and patients frequently relapse. The
demonstrated superiority of high-dose chemotherapy with stem cell
support over conventional chemotherapy for the treatment of MM has
made ASCT the current standard of care for patients, particularly
the young, with adequate organ function. Melphalan is the most
commonly used IV agent for high-dose conditioning for patients
undergoing ASCT for MM. The current IV melphalan market is
approximately $100 million annually, with predominant use in
ASCT.
About EVOMELA™
EVOMELA is a new propylene glycol-free melphalan formulation
that has been previously shown to be bioequivalent to the standard
melphalan formulation (Alkeran) in a Phase 2 clinical study
(Aljitawi et al, Bone Marrow Transplant, 2014). EVOMELA has been
granted an Orphan Drug Designation by the FDA for the MM
setting.
This formulation eliminates the need to use a propylene glycol
containing custom diluent, which is required with other
formulations and has been reported to cause renal and cardiac side
effects. The use of the Captisol® technology to reformulate
melphalan also improves its stability, and is anticipated to allow
for slower infusion rates and longer administration durations,
potentially enabling clinicians to safely achieve a higher dose
intensity for pre-transplant chemotherapy.
Spectrum Pharmaceuticals gained global development and
commercialization rights to EVOMELA from Ligand
Pharmaceuticals Incorporated (NASDAQ: LGND) in March 2013.
Spectrum assumed responsibility for completing the pivotal clinical
trial and was responsible for filing the NDA. Under the license
agreement, Ligand received a license fee and is eligible to receive
milestone payments, as well as royalties following potential
commercialization.
About Captisol®
Captisol is a patent-protected, chemically modified cyclodextrin
with a structure designed to optimize the solubility and stability
of drugs. Captisol was invented and initially developed by
scientists in the laboratories of Dr. Valentino Stella at the
University of Kansas’ Higuchi Biosciences Center for specific use
in drug development and formulation. This unique technology has
enabled six FDA-approved products, including Onyx Pharmaceuticals’
Kyprolis®, Baxter International’s Nexterone® and Merck’s NOXAFIL
IV. There are also more than 30 Captisol-enabled products currently
in clinical development.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
performance of Spectrum Pharmaceuticals that involve risks and
uncertainties that could cause actual results to differ materially.
These statements are based on management's current beliefs and
expectations. These statements include, but are not limited to,
statements that relate to our business and its future, including
certain company milestones, Spectrum's ability to identify,
acquire, develop and commercialize a broad and diverse pipeline of
late-stage clinical and commercial products, leveraging the
expertise of partners and employees around the world to assist us
in the execution of our strategy, and any statements that relate to
the intent, belief, plans or expectations of Spectrum or its
management, or that are not a statement of historical fact. Risks
that could cause actual results to differ include the possibility
that our existing and new drug candidates may not prove safe or
effective, the possibility that our existing and new applications
to the FDA and other regulatory agencies may not receive approval
in a timely manner or at all, the possibility that our existing and
new drug candidates, if approved, may not be more effective, safer
or more cost efficient than competing drugs, the possibility that
our efforts to acquire or in-license and develop additional drug
candidates may fail, our lack of sustained revenue history, our
limited marketing experience, our dependence on third parties for
clinical trials, manufacturing, distribution and quality control
and other risks that are described in further detail in the
Company's reports filed with the Securities and Exchange
Commission. We do not plan to update any such forward-looking
statements and expressly disclaim any duty to update the
information contained in this press release except as required by
law.
SPECTRUM PHARMACEUTICALS, INC.®, FUSILEV®, FOLOTYN®, ZEVALIN®,
MARQIBO®, and BELEODAQ® are registered trademarks of Spectrum
Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™,
EVOMELA™ and the Spectrum Pharmaceuticals logos are trademarks
owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are
the property of their respective owners.
© 2015 Spectrum Pharmaceuticals, Inc. All Rights Reserved
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150902005455/en/
Spectrum Pharmaceuticals, Inc.Shiv Kapoor, 702-835-6300Vice
President, Strategic Planning & Investor
RelationsInvestorRelations@sppirx.com
Spectrum Pharmaceuticals (NASDAQ:SPPI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Spectrum Pharmaceuticals (NASDAQ:SPPI)
Historical Stock Chart
From Apr 2023 to Apr 2024