Spectrum Pharmaceuticals and Onxeo Announce Complete Response in 67% of Patients with Peripheral T-Cell Lymphoma in Combination of Belinostat...

  · Data was Highlighted in an Oral Presentation of a Phase 1 Study at the 57th
Annual Meeting of the American Society of Hematology (ASH)
  · Study Shows 86% Objective Response Rate with 67% Complete Responses in Newly
Diagnosed Patients with Peripheral T-cell Lymphoma (PTCL)
  · At Full Dose Intensity the Belinostat-CHOP Combination was Well-Tolerated
HENDERSON, Nev. & PARIS & COPENHAGEN, Denmark--(BUSINESS
WIRE (http://www.businesswire.com/))-- Regulatory News:

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully
integrated commercial and drug development operations and a primary focus in
Hematology and Oncology, and Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen:
ONXEO), an innovative company specializing in the development of orphan oncology
drugs, today jointly announced the results from their Phase 1 combination trial
of belinostat (Beleodaq®) with the CHOP (Cyclophosphamide, Hydroxyl-doxorubicin;
Vincristine, and Prednisone) chemotherapy regimen as first-line treatment for
newly diagnosed peripheral T-cell lymphoma (PTCL). Beleodaq® is a histone
deacetylase (HDAC) inhibitor that received accelerated approval by the U.S. Food
and Drug Administration (FDA) for the treatment of relapsed or refractory PTCL
in July 2014.

The results were presented today in an oral presentation at the 57th American
Society of Hematology (ASH) Annual Meeting &
Exposition (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.
h 
ematology.org%2FAnnual-Meeting%2F&esheet=51237996&newsitemid=0&lan=en
-US&anchor=57th+American+Society+of+Hematology+%28ASH%29+Annual+Meeting+%26+Expo
s 
ition&index=1&md5=922c72fdc6cee1dc864ba72ef1dde328) by Dr. Patrick Johnston, MD,
PhD, Assistant Professor of Medicine at the Mayo Clinic, Rochester, MN, USA.

Abstract #253: Safe and Effective Treatment of Patients with Peripheral T-cell
Lymphoma (PTCL) with the Novel HDAC Inhibitor, Belinostat, in Combination with
CHOP: Results of the Bel-CHOP Phase 1 Trial

This open-label, two-part trial enrolled a total of 23 patients. Eleven were
enrolled in Part A, the dose-escalation phase, to determine the study’s primary
endpoint, the maximum tolerated dose (MTD). Part B of the study, the Expansion
Phase, enrolled 12 additional patients at this dose level. The MTD of belinostat
was established at 1,000 mg/m2 IV infusion on Days 1-5 (the recommended single
agent dose) when combined with the CHOP regimen, with each component given at
its full recommended dose. Secondary endpoints included safety, tolerability,
Objective Response Rate (ORR: Complete Response + Partial Response), and
pharmacokinetics.

Results outlined in the oral presentation showed an ORR of 86% with the
belinostat and CHOP combination, based on 21 evaluable patients (18/21), with
the vast majority, 67%, achieving a Complete Response (14/21), and 19% achieving
a Partial Response (4/21). In addition, the belinostat and CHOP combination was
shown to have an acceptable safety profile with no new or unexpected toxicities.
The most common (>10%) Grade 3-4 hematologic adverse events (AEs) reported with
Bel-CHOP were as expected: neutrophil count decreased (30%), anemia (22%),
neutropenia (22%), white blood cell (WBC) count decreased (22%), febrile
neutropenia (17%) and lymphocyte count decreased (17%). No Grade 3-4 non
-hematologic AEs >10% were reported. No patient discontinued therapy due to AEs.
One patient died as a result of disease progression during the study.

Dr. Patrick Johnston, MD, PhD, Assistant Professor of Medicine at the Mayo
Clinic and investigator on the trial, commented, “PTCL is a very difficult
lymphoma to treat due to its heterogeneous nature, and its association with
multiple recurrence and poor prognosis; only approximately 37% of patients
achieve 5-year overall survival. New combination treatment strategies are
undeniably needed to improve efficacy without compromising tolerability, and we
are encouraged by these Phase 1 study results indicating that the combination of
belinostat and CHOP is a potentially viable treatment option. A good safety
profile combined with an Objective Response Rate of 86%, and 67% of patients
achieving complete response, are unusual in an early trial of this cancer type.
We look forward to further evaluating the combination in a planned Phase 3
trial.”

“We are proud to have had several presentations on our products at the ASH
meeting, and are optimistic about the new combination data with belinostat,”
said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum
Pharmaceuticals. “Beleodaq was approved for the treatment of patients with
relapsed or refractory PTCL based on an Objective Response Rate in the pivotal
Phase 2 BELIEF study of 25.8%. The results of this Phase 1 study indicate
encouraging safety and efficacy for the combination of belinostat and CHOP in
newly diagnosed patients. The clinical activity suggests that earlier treatment
with belinostat could be beneficial for the treatment of this devastating
disease. Spectrum has a unique PTCL franchise with two FDA approved drugs; we
are very proud to be able to offer patients and clinicians additional treatment
options for a disease which had no FDA-approved treatments until a few years
ago.”

Graham Dixon, PhD, Chief Scientific Officer of Onxeo, added, “We are very
excited to have these results discussed in an oral presentation at the ASH
Annual Meeting. Collectively, the efficacy and safety findings demonstrate the
potential value of belinostat plus CHOP, and Onxeo is thrilled to continue the
development of belinostat to more broadly assess this promising therapy in PTCL
and beyond.”

References

1. Johnston, P. “Safe and Effective Treatment of Patients with Peripheral T-cell
Lymphoma (PTCL) with the Novel HDAC Inhibitor, Belinostat, in Combination with
CHOP: Results of the BelCHOP Phase 1 Trial.” Abstract #253 accepted for Oral
Presentation at the 2015 ASH Annual Meeting, Dec. 5-8, 2015. Abstract available
online
at: https://ash.confex.com/ash/2015/webprogram/Paper83281.html (http://cts.busin
e 
sswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fash.confex.com%2Fash%2F2015%2Fwe
b 
program%2FPaper83281.html&esheet=51237996&newsitemid=0&lan=en
-US&anchor=https%3A%2F%2Fash.confex.com%2Fash%2F2015%2Fwebprogram%2FPaper83281.h
t 
ml&index=2&md5=f0f3df7bb49f37980c298697b41c8216)

About BELEODAQ®

Beleodaq (belinostat) is a histone deacetylase (HDAC) inhibitor. HDACs catalyze
the removal of acetyl groups from the lysine residues of histones and some non
-histone proteins. In vitro, belinostat caused the accumulation of acetylated
histones and other proteins, inducing cell cycle arrest and/or apoptosis of some
transformed cells. Belinostat shows preferential cytotoxicity towards tumor
cells compared to normal cells. Belinostat inhibited the enzymatic activity of
histone deacetylases at nanomolar concentrations (

Indications and Usage

Beleodaq is a histone deacetylase inhibitor indicated for the treatment of
patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This
indication is approved under accelerated approval based on tumor response rate
and duration of response. An improvement in survival or disease-related symptoms
has not been established. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in the
confirmatory trial.

Important Beleodaq Safety Information

Warnings and Precautions

  · Beleodaq can cause thrombocytopenia, leukopenia (neutropenia and
lymphopenia), and/or anemia; monitor blood counts weekly during treatment, and
modify dosage as necessary.
  · Serious and sometimes fatal infections, including pneumonia and sepsis, have
occurred with Beleodaq. Do not administer Beleodaq to patients with an active
infection. Patients with a history of extensive or intensive chemotherapy may be
at higher risk of life threatening infections.
  · Beleodaq can cause fatal hepatotoxicity and liver function test
abnormalities. Monitor liver function tests before treatment and before the
start of each cycle. Interrupt or adjust dosage until recovery, or permanently
discontinue Beleodaq based on the severity of the hepatic toxicity.
  · Tumor lysis syndrome has occurred in Beleodaq-treated patients in the
clinical trial of patients with relapsed or refractory PTCL. Monitor patients
with advanced stage disease and/or high tumor burden and take appropriate
precautions.
  · Nausea, vomiting and diarrhea occur with Beleodaq and may require the use of
antiemetic and antidiarrheal medications.
  · Beleodaq can cause fetal harm when administered to a pregnant woman. Women
of childbearing potential should be advised to avoid pregnancy while receiving
Beleodaq. If this drug is used during pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of potential
hazard to the fetus.

Adverse Reactions

  · The most common adverse reactions observed in the trial in patients with
relapsed or refractory PTCL treated with Beleodaq were nausea (42%), fatigue
(37%), pyrexia (35%), anemia (32%), and vomiting (29%).
  · Sixty-one patients (47.3%) experienced serious adverse reactions while
taking Beleodaq or within 30 days after their last dose of Beleodaq.

Drug Interactions

  · Beleodaq is primarily metabolized by UGT1A1. Avoid concomitant
administration of Beleodaq with strong inhibitors of UGT1A1.

Use in Specific Populations

  · It is not known whether belinostat is excreted in human milk. Because of the
potential for serious adverse reactions in nursing infants from Beleodaq, a
decision should be made whether to discontinue nursing or discontinue drug,
taking into account the importance of the drug to the mother.

Please see Beleodaq Full Prescribing Information
at www.beleodaq.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%
2 
F%2Fwww.beleodaq.com&esheet=51237996&newsitemid=0&lan=en
-US&anchor=www.beleodaq.com&index=3&md5=8e6e638ddb50ab0a6847d537e0e12617)

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a leading biotechnology company focused on
acquiring, developing, and commercializing drug products, with a primary focus
in Oncology and Hematology. Spectrum and its affiliates market five oncology
drugs─ FUSILEV® (levoleucovorin) for Injection in the U.S.;
FOLOTYN® (pralatrexate injection), also marketed in the U.S.;
ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which the
Company has worldwide marketing rights; MARQIBO® (vinCRIStine sulfate LIPOSOME
injection) for intravenous infusion, for which the Company has worldwide
marketing rights, and BELEODAQ® (belinostat) for Injection in the U.S.
Additionally, Spectrum's pipeline includes three drugs targeting blockbuster
markets in advanced stages of clinical development. Spectrum's strong track
record in in-licensing and acquiring differentiated drugs, and expertise and
proven track record 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 (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F
% 
2Fwww.sppirx.com&esheet=51237996&newsitemid=0&lan=en
-US&anchor=www.sppirx.com&index=4&md5=f18d164b5cf3e053ea2b035e408a48d5).

SPECTRUM PHARMACEUTICALS, INC.®, FUSILEV®, FOLOTYN®, ZEVALIN®, MARQIBO®, and
BELEODAQ® are registered trademarks of Spectrum Pharmaceuticals, Inc and its
affiliates. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are
trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the
property of their respective owners.

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.

© 2015 Spectrum Pharmaceuticals, Inc. All Rights Reserved

About Onxeo

Onxeo has the vision to become a global leader and pioneer in oncology, with a
focus on orphan or rare cancers, through developing innovative therapeutic
alternatives designed to “make the difference”. The Onxeo team is determined to
develop innovative medicines that provide patients with hope and significantly
improve their lives.

Key orphan oncology products at the advanced development stage are:

  · Livatag® (Doxorubicin Transdrug™)
  · Validive® (Clonidine Lauriad®)
  · Beleodaq® (belinostat)

For more information, visit the
website www.onxeo.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3
A 
%2F%2Fwww.onxeo.com&esheet=51237996&newsitemid=0&lan=en
-US&anchor=www.onxeo.com&index=5&md5=c62420c580b8887321ad98d6ec230bd2)

Disclaimer

This communication expressly or implicitly contains certain forward-looking
statements concerning Onxeo and its business. Such statements involve certain
known and unknown risks, uncertainties and other factors, which could cause the
actual results, financial condition, performance or achievements of Onxeo to be
materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Onxeo is providing this
communication as of this date and does not undertake to update any forward
-looking statements contained herein as a result of new information, future
events or otherwise. For a discussion of risks and uncertainties which could
cause actual results, financial condition, performance or achievements of Onxeo
to differ from those contained in the forward-looking statements, please refer
to the Risk Factors ("Facteurs de Risque") section of the 2014 Reference
Document filed with the AMF on April 14, 2015, which is available on the AMF
website (http://www.amf
-france.org (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww
. 
amf-france.org&esheet=51237996&newsitemid=0&lan=en
-US&anchor=http%3A%2F%2Fwww.amf
-france.org&index=6&md5=2b19c8391cfb3a2e2a894a6ab964bbe1)) or on the company’s
website
(www.onxeo.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2F
w 
ww.onxeo.com&esheet=51237996&newsitemid=0&lan=en
-US&anchor=www.onxeo.com&index=7&md5=0925c172fc257ec0b0b4f01c7679348f)).
Contacts

Spectrum Pharmaceuticals:
Shiv Kapoor
Vice President, Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com
or
Onxeo:
Nathalie Delair-Trepo
Investor Relations
investors@onxeo.com
+33 1 45 58 76 00
or
Caroline Carmagnol / Florence Portejoie – Alize RP (France)
onxeo@alizerp.com
+33 6 64 18 99 59 / +33 1 44 54 36 64
or
Kirsten Thomas / Lee Roth – The Ruth Group (U.S.)
kthomas@theruthgroup.com / lroth@theruthgroup.com
+1 508 280 6592 / +1 646 536 7012