Spectrum Pharmaceuticals Announces Positive Data from the BELIEF Trial Presented at the 2013 America

Spectrum Pharmaceuticals Announces Positive Data from the BELIEF Trial Presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting

  • Important clinical efficacy demonstrated with single agent belinostat in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) including poor prognosis subtypes
  • Safety profile in patients with poor marrow reserve that allowed for the delivery of high dose intensity treatment to heavily pretreated patients, and the potential for the development of new treatment combinations for PTCL

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in hematology and oncology, today announced positive results from the BELIEF trial, a pivotal, single-arm study of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) after failure of ≥1 prior systemic therapies. Data presented at an oral session at ASCO demonstrated the clinical activity of belinostat, a novel pan-histone deacetylase inhibitor, in treating patients (N=129) with R/R PTCL with:

  • Overall Response Rate (ORR) of 26% in heavily pretreated patients
  • Median Duration of Response (DoR) of 13.6 months by International Working Group (IWG) criteria
  • Anti-tumor activity demonstrated in poor prognosis PTCL subtypes including angioimmunoblastic T-cell lymphoma (AITL) with a ORR of 46%, patients with poor marrow reserves and low platelet counts (<100,000 per mcL), and patients with previous autologous and allogeneic stem cell transplants
  • Well tolerated with an acceptable safety profile and >98% dose intensity that could potentially allow for novel combination chemotherapies

"These data are very encouraging and demonstrate the potential clinical activity and safety of belinostat as a single agent in the treatment of patients with relapsed or refractory PTCL," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Despite the recent approvals of new treatments for R/R PTCL, there remains an unmet medical need with approximately 70% of patients failing current therapies, so clearly these patients need alternative effective treatment options. We are excited that Spectrum is on track to file an NDA for belinostat for this indication in 2013."

"In this study, Belinostat demonstrated important clinical efficacy in poor prognosis relapsed and refractory PTCL patients," said Dr. Owen A. O'Connor, Professor of Medical and Experimental Therapeutics and Director of the Center for Lymphoid Malignancies at the Columbia University Medical Center College of Physicians and Surgeons, one of the lead investigators in the belinostat study. "Its safety profile and tolerability in patients with poor marrow reserve makes it an ideal candidate for the development of new combination treatment paradigms for PTCL."

The BELIEF study enrolled 129 PTCL patients refractory to or who had failed at least one prior systemic therapy; diagnosis was confirmed by Central Pathology Review. Patients received belinostat at 1,000 mg/m2 as a 30 minute intravenous infusion on days 1 thru 5 every 21 days. The primary study end point was the overall response rate (ORR) as assessed by an Independent Review Committee.

Single-agent belinostat was shown to induce complete and partial responses even in poor prognosis R/R PTCL subtypes, e.g., angioimmunoblastic T-cell lymphoma (AITL) and ALK (-) anaplastic large cell lymphoma. Overall, belinostat was well-tolerated, requiring minimal dose reductions or dose delays leading to the successful delivery of high dose intensity treatment to heavily pretreated patients.

About Belinostat

Belinostat (PXD 101) is a pan-HDAC inhibitor being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers. Its anticancer effect is thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis (programmed cell death), inhibition of angiogenesis, induction of differentiation, and the resensitization of cells that have become resistant to anticancer agents such as platinums, taxanes and topoisomerase II inhibitors. Belinostat is the only HDAC inhibitor in clinical development with multiple potential routes of administration, including intravenous administration, continuous intravenous infusion and oral administration.

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 three oncology drugs ─ FUSILEV® (levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate injection), also marketed in the U.S.; and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights. Spectrum's strong track record in 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.

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 ® , and ZEVALIN ® 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.

© 2013 Spectrum Pharmaceuticals, Inc. All Rights Reserved.



Spectrum Pharmaceuticals, Inc.
Shiv Kapoor, 702-835-6300
Vice President, Strategic Planning & Investor Relations
InvestorRelations@sppirx.com

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