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Allos Therapeutics Reports New Data Demonstrating that Responses to FOLOTYN are Correlated with Prolonged Survival in Patients

^{Published on 2010-06-05 12:40:24 - Market Wire}
 

CHICAGO & WESTMINSTER, Colo.--([ BUSINESS WIRE ])--Allos Therapeutics, Inc. (Nasdaq: ALTH) today reported new analyses of data from the Companya™s pivotal PROPEL trial of FOLOTYN^® (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). These analyses demonstrated that patients who responded to FOLOTYN had up to a 44% reduction in risk of death based on independent central review of response (P=.07), and up to a 56% reduction in risk of death based on investigator review of response (P=<.01), when compared with patients whose disease did not respond to FOLOTYN. These analyses also demonstrated that patients with stable disease who received FOLOTYN had a reduction in the risk of death when compared to patients with progressive disease. These data were presented during a poster session at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 4-8, 2010 in Chicago, Illinois.

"With peripheral T-cell lymphoma, there is an urgent need for treatments that help patients live longer"

aWith peripheral T-cell lymphoma, there is an urgent need for treatments that help patients live longer,a said Barbara Pro, M.D., associate professor in the Department of Lymphoma/Myeloma at the University of Texas M. D. Anderson Cancer Center. aThe results of the PROPEL study demonstrate FOLOTYNa™s substantial antitumor activity in patients with relapsed or refractory PTCL, which is correlated with prolonged survival for patients with both responsive and stable disease. This is an important finding in this aggressive and difficult-to-treat lymphoma. Survival is the ultimate goal for patients and clinicians, and these data support the growing body of clinical evidence suggesting that FOLOTYN is an effective treatment option for patients with relapsed or refractory PTCL.a

PROPEL Poster Presentation

Abstract #8054 Pralatrexate in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma
(PTCL): Relationship Between Response and Survival

A poster presentation characterized the relationship between response to FOLOTYN and survival among patients with relapsed or refractory PTCL in the PROPEL study. The relationship between objective response and survival were analyzed using time-dependent covariate and landmark methods, which are two well accepted statistical methods for analyzing the association between tumor objective response and survival.

• 109 patients were evaluated for safety and efficacy, including 69 patients (63%) who had no evidence of response to the most recent prior therapy.
  • These patients achieved an overall response rate of 29% (32/109) based on independent central review of response, and 39% (40/109) based on investigator review of response.
  • Responses were durable with a median duration of response of 10.1 months based on independent central review.
  • Additionally, according to independent central review, 63% of all responses occurred within the first cycle (<7 weeks). The cycle 1 responses were used for the landmark analysis.
  • Median overall survival was 14.5 months with 55% of patients surviving >12 months.
  • In the time-dependent covariate analyses, patients who responded to FOLOTYN had a 44% reduction in risk of death (P=.07) based on independent central review of response, and a 56% reduction in risk of death (P=<.01) based on investigator review of response, when compared with patients who did not have a complete or partial response.
  • In the landmark analyses, patients who responded to FOLOTYN had a 31% reduction in risk of death (P=.32) based on independent central review of response, and a 49% reduction in risk of death (P=.03) based on investigator review of response, when compared with patients who did not have a complete or partial response.
  • Further exploratory analysis showed that stable disease also correlated with improved survival compared to patients with progressive disease.

About PROPEL

The open-label, single-arm, multicenter, international Phase 2 clinical trial is the largest prospective study of its type ever conducted in patients with relapsed or refractory PTCL. PROPEL enrolled 115 patients with relapsed or refractory PTCL, 109 of whom were considered evaluable for efficacy according to the trial protocol. Patients were considered evaluable if they received at least one dose of FOLOTYN, their diagnosis of PTCL was confirmed by independent pathology review, and they had relapsed or refractory disease after at least one prior treatment. Patients were treated with FOLOTYN at 30 mg/m² once weekly by IV push over 3-5 minutes for 6 weeks in 7-week cycles until disease progression or unacceptable toxicity. In addition, patients received 1mg of vitamin B₁₂ intramuscularly every 8-10 weeks and 1.0-1.25 mg of folic acid orally on a daily basis.

The primary efficacy endpoint was overall response rate (complete response, complete response unconfirmed and partial response) as assessed by International Workshop Criteria (IWC). The key secondary efficacy endpoint was duration of response. Response assessments were scheduled at the end of cycle 1 and then every other cycle (every 14 weeks). Duration of response was measured from the first day of documented response to disease progression or death. Response and disease progression were evaluated by independent central review using International Workshop Criteria.

About Peripheral T-cell Lymphoma (PTCL)

T-cell lymphomas comprise a biologically diverse group of blood cancers that account for approximately 10% to 15% of all cases of non-Hodgkina™s lymphoma (NHL) in the United States.^1-3 The American Cancer Society estimated that approximately 66,000 new cases of NHL were expected to be diagnosed in the U.S. in 2009. The Company estimates the current annual incidence of PTCL in the U.S. to be approximately 5,900 patients. The outcome of patients with PTCL is poor and the majority of patients ultimately have refractory disease to a variety of agents, including multi-agent chemotherapy with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or CHOP-like regimens. The 5-year overall survival rate in these patients is 25% to 40%, depending on sub-type.^4-5

About Allos Therapeutics

Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics. Allos is currently focused on the development and commercialization of FOLOTYN^® (pralatrexate injection), a folate analogue metabolic inhibitor. FOLOTYN is the first and only drug approved in the U.S. for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. The FDA approved FOLOTYN under the agencya™s accelerated approval process. Allos is also developing FOLOTYN in other potential indications. Allos retains exclusive worldwide rights to FOLOTYN for all indications. Allos is headquartered in Westminster, Colo. For additional information, please visit [ www.allos.com ].

Important Safety Information

Warnings and Precautions:

FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities.

Mucositis may occur. If a Grade 2 mucositis is observed, omit or modify dose.

Patients should be instructed to take folic acid and receive vitamin B₁₂ to potentially reduce treatment-related hematological toxicity and mucositis.

FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN, and pregnant women should be informed of the potential harm to the fetus.

Use caution and monitor patients when administering FOLOTYN to patients with moderate to severe renal function impairment.

Elevated liver function test abnormalities may occur and require monitoring. If liver function test abnormalities are a Grade 3, omit or modify dose.

Dermatologic reactions may occur. Patients with dermatologic reactions should be monitored closely.

Adverse Reactions:

The most common adverse reactions observed were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea and thrombocytopenia.

Use in Specific Patient Population:

Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.

Drug Interactions:

Co-administration of drugs subject to renal clearance (e.g., probenecid, NSAIDs, and trimethoprim/sulfamethaxazole) may result in delayed renal clearance.

For additional important safety information, please see the full prescribing information for FOLOTYN at [ www.allos.com ].

Safe Harbor Statement

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the estimated incidence of PTCL in the U.S.; Allos' future product development and regulatory strategies, including its intent to develop or seek regulatory approval for FOLOTYN in additional indications; and other statements that are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. Important factors that may cause actual results to differ materially include, but are not limited to, that Allos may experience difficulties or delays in the initiation, progress or completion of its clinical trials, whether caused by competition, adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues or other factors; and that Allos may lack the financial resources and access to capital to support its future operations, including its product development and commercialization plans for FOLOTYN. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2010, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Allos on the date hereof, and Allos undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law.

Note: The Allos logo and FOLOTYN name are trademarks of Allos Therapeutics, Inc.

References:

1. The Non-Hodgkin's Lymphoma Classification Project. A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkina™s lymphoma. Blood. 1997;89(11):3909-3908.

2. Hennessy BT, Hanrahan EO, Daly PA. Non-Hodgkin lymphoma: an update [review]. Lancet Oncol. 2004;5(6):341-353.

3. O'Leary HM, Savage KJ. Novel therapies in peripheral T-cell lymphomas [review]. Curr Oncol Rep. 2008;134(5):202-207.

4. Savage KJ, Chhanabhai M, Gascoyne RD, et al. Characterization of peripheral T-cell lymphomas in a single North American institution by the WHO classification. Ann Oncol 2004;15(10):1467-75.

5. Savage KJ. Peripheral T-cell Lymphomas. Blood Rev. 2007;21:201-216.