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June 5, 2012
Spectrum Pharmaceuticals Announces Promising Clinical Data for ZEVALIN® and Belinostat at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting
•Promising ZEVALIN data reported in patients with diffuse large B-cell lymphoma (DLBCL); data suggest reduced need for standard chemotherapy.
•ZEVALIN poster presentations also show positive results in diverse patient populations, including those receiving stem cell transplants and the elderly
•Belinostat therapy shows encouraging activity in combination with chemotherapy regimen against aggressive form of lymphoma
HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced promising clinical data in five poster presentations for ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, as well as a poster presentation and one e-abstract publication for belinostat, at the American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, Illinois, from June 1-5, 2012.
ZEVALIN - Promising clinical findings in DLBCL, including in elderly patients; ZEVALIN further associated with reduced need for chemotherapy
A Phase 2 investigator-sponsored study in patients with stage III/IV CD20+ DLBCL (Abstract # 6633) found that short-duration therapy consisting of rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone given every 14 days (RCHOP-14) followed by ZEVALIN resulted in a 3-year overall survival (OS) of 100%. Three-year progression-free survival (PFS) was 90% in this patient cohort. The Phase 2 study was an international, open-label, non-randomized trial in a total of 30 CD20+ DLBCL patients aged between 65 and 80, 25 of whom completed treatment.
An additional investigator-sponsored Phase 2 study (Abstract #8056) demonstrated that short-duration therapy of ZEVALIN with rituximab showed complete response rate durations comparable to full-course R-CHOP in patients with first or second relapse follicular lymphoma.
"The promising results for first-line, short regimen RCHOP-14 treatment plus ZEVALIN, along with other key clinical findings, have formed the basis of the Spectrum-sponsored Phase 3 trial of ZEVALIN in first-line consolidation DLBCL studies (also known as the 'ZEST' trial) with standard dose RCHOP induction," stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "The data suggest that an already convenient ZEVALIN treatment regimen could become even more convenient administered following a short course chemotherapy regimen to additional patient populations with significant unmet needs, such as elderly patients with CD20+ DLBCL, to minimize the need for chemotherapy and thus avoid toxicity. We look forward to the continued progress of our ZEST program."
ZEVALIN - Positive results in patients receiving stem cell transplants
Three poster presentations of investigator-sponsored studies at the ASCO meeting reported positive findings in lymphoma patients who have received stem cell transplantation:
• According to data from a prospective Phase 1/2 study (ASCO Abstract 6543), combining ZEVALIN with BCNU, etoposide, cytarabine, melphalan (BEAM) therapy - Z-BEAM - resulted in a high response rate with durable remissions in rituximab-pretreated patient with aggressive B-cell non-Hodgkin's lymphoma (NHL) who received autologous stem cell transplantation (ASCT).
• Z-BEAM therapy also was seen in a Phase 2 study to overcome some of the poor prognosis for patients with relapsed/refractory non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL) (Abstract #6547) who received ASCT.
• Results of a Phase 2 study (Abstract # 6545) demonstrated that ZEVALIN reduced relapses when administered in combination with fludarabine and melphalan to post-allogeneic hematopoietic cell transplantation patients with refractory B-cell NHL.
Belinostat - Encouraging results in refractory aggressive B-cell lymphomas and in combination with cisplatin, doxorubicin, and cyclophosphamide (PAC)
Clinical results appearing in an e-publication (Abstract # e18536) titled, "A Phase II Study of PXD101 (belinostat) in Relapsed and Refractory Aggressive B-Cell Lymphomas (rel/ref ABCL): SWOG S0520," highlighted positive data providing a foundation for the Company's current clinical program of belinostat. In the study published during ASCO, patients with relapsed/refractory aggressive B-cell lymphoma were treated with belinostat given as monotherapy, 1000 mg/m2 IV days 1-5 of 21-day cycle for up to 2 years. The primary objective was to evaluate response rate and toxicity of belinostat in patients with rel/ref ABCL with up to five prior chemotherapy regimens. Secondary objectives were to estimate the six-month PFS and to assess major histocompatibility Class II antigens (MHC II) and tumor-infiltrating T lymphocytes (TIL).
According to the results, two patients had partial remission at five and 13 months during the follow-up period, for an overall response rate (95% CI) of 10.5%, and three patients had stable disease for a prolonged period of time (4.7, 30.4+, and 40.7+ months). In all, four patients (21%) had no progression for greater than two years.
Further, a poster presentation (Abstract #7103) featured Phase 1/2 results showing that belinostat plus cisplatin, doxorubicin, and cyclophosphamide (PAC) has activity in thymic malignancies with a predictable adverse event profile. A Phase 2 trial is ongoing.
About Non-Hodgkin's Lymphoma
According to the National Cancer Institute (www.cancer.gov), there are expected to be 70,130 new cases of non-Hodgkin's lymphoma diagnosed and approximately 18,940 deaths in the United States in 2012. Non-Hodgkin's lymphoma is defined as any of a large group of cancers of lymphocytes (white blood cells). Non-Hodgkin's lymphomas can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss. There are many different types of non-Hodgkin's lymphoma. These types can be divided into aggressive (fast-growing) and indolent or low grade (slow-growing) types, and they can be formed from either B-cells or T-cells. Prognosis and treatment depend on the stage and type of disease.
About ZEVALIN® and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). ZEVALIN is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma who achieve a partial or complete response to first-line chemotherapy.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
Important ZEVALIN® Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration can result in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.
Please see full Prescribing Information, including BOXED WARNINGS, for ZEVALIN and rituximab. Full prescribing information for ZEVALIN can be found at www.ZEVALIN.com.
About Belinostat
Belinostat (PXD 101) is a Class I and II 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.
Belinostat is currently in a registrational trial, the BELIEF Study, under a SPA, as monotherapy for relapsed or refractory peripheral T-cell lymphoma (PTCL), an indication for which it has been granted Orphan Drug and Fast Track designations by the FDA. Belinostat is also under investigation in a randomized Phase 2 trial, as a combination therapy with carboplatin and paclitaxel, for cancer of unknown primary (CUP). The CUP study is being run and fully funded by our partner Topotarget A/S. Additionally, the National Cancer Institute is currently conducting several clinical trials of belinostat in a variety of hematological and solid tumors, both as monotherapy as well as combination therapy.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV® (levoleucovorin) for Injection and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use. In addition, Spectrum has two drugs, belinostat and apaziquone, in late-stage development and a diversified pipeline of novel drug candidates in earlier stages of development. The Company's strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. The Company has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company's website 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.®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved
June 5, 2012
Spectrum Pharmaceuticals Announces Promising Clinical Data for ZEVALIN® and Belinostat at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting
•Promising ZEVALIN data reported in patients with diffuse large B-cell lymphoma (DLBCL); data suggest reduced need for standard chemotherapy.
•ZEVALIN poster presentations also show positive results in diverse patient populations, including those receiving stem cell transplants and the elderly
•Belinostat therapy shows encouraging activity in combination with chemotherapy regimen against aggressive form of lymphoma
HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced promising clinical data in five poster presentations for ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, as well as a poster presentation and one e-abstract publication for belinostat, at the American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, Illinois, from June 1-5, 2012.
ZEVALIN - Promising clinical findings in DLBCL, including in elderly patients; ZEVALIN further associated with reduced need for chemotherapy
A Phase 2 investigator-sponsored study in patients with stage III/IV CD20+ DLBCL (Abstract # 6633) found that short-duration therapy consisting of rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone given every 14 days (RCHOP-14) followed by ZEVALIN resulted in a 3-year overall survival (OS) of 100%. Three-year progression-free survival (PFS) was 90% in this patient cohort. The Phase 2 study was an international, open-label, non-randomized trial in a total of 30 CD20+ DLBCL patients aged between 65 and 80, 25 of whom completed treatment.
An additional investigator-sponsored Phase 2 study (Abstract #8056) demonstrated that short-duration therapy of ZEVALIN with rituximab showed complete response rate durations comparable to full-course R-CHOP in patients with first or second relapse follicular lymphoma.
"The promising results for first-line, short regimen RCHOP-14 treatment plus ZEVALIN, along with other key clinical findings, have formed the basis of the Spectrum-sponsored Phase 3 trial of ZEVALIN in first-line consolidation DLBCL studies (also known as the 'ZEST' trial) with standard dose RCHOP induction," stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "The data suggest that an already convenient ZEVALIN treatment regimen could become even more convenient administered following a short course chemotherapy regimen to additional patient populations with significant unmet needs, such as elderly patients with CD20+ DLBCL, to minimize the need for chemotherapy and thus avoid toxicity. We look forward to the continued progress of our ZEST program."
ZEVALIN - Positive results in patients receiving stem cell transplants
Three poster presentations of investigator-sponsored studies at the ASCO meeting reported positive findings in lymphoma patients who have received stem cell transplantation:
• According to data from a prospective Phase 1/2 study (ASCO Abstract 6543), combining ZEVALIN with BCNU, etoposide, cytarabine, melphalan (BEAM) therapy - Z-BEAM - resulted in a high response rate with durable remissions in rituximab-pretreated patient with aggressive B-cell non-Hodgkin's lymphoma (NHL) who received autologous stem cell transplantation (ASCT).
• Z-BEAM therapy also was seen in a Phase 2 study to overcome some of the poor prognosis for patients with relapsed/refractory non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL) (Abstract #6547) who received ASCT.
• Results of a Phase 2 study (Abstract # 6545) demonstrated that ZEVALIN reduced relapses when administered in combination with fludarabine and melphalan to post-allogeneic hematopoietic cell transplantation patients with refractory B-cell NHL.
Belinostat - Encouraging results in refractory aggressive B-cell lymphomas and in combination with cisplatin, doxorubicin, and cyclophosphamide (PAC)
Clinical results appearing in an e-publication (Abstract # e18536) titled, "A Phase II Study of PXD101 (belinostat) in Relapsed and Refractory Aggressive B-Cell Lymphomas (rel/ref ABCL): SWOG S0520," highlighted positive data providing a foundation for the Company's current clinical program of belinostat. In the study published during ASCO, patients with relapsed/refractory aggressive B-cell lymphoma were treated with belinostat given as monotherapy, 1000 mg/m2 IV days 1-5 of 21-day cycle for up to 2 years. The primary objective was to evaluate response rate and toxicity of belinostat in patients with rel/ref ABCL with up to five prior chemotherapy regimens. Secondary objectives were to estimate the six-month PFS and to assess major histocompatibility Class II antigens (MHC II) and tumor-infiltrating T lymphocytes (TIL).
According to the results, two patients had partial remission at five and 13 months during the follow-up period, for an overall response rate (95% CI) of 10.5%, and three patients had stable disease for a prolonged period of time (4.7, 30.4+, and 40.7+ months). In all, four patients (21%) had no progression for greater than two years.
Further, a poster presentation (Abstract #7103) featured Phase 1/2 results showing that belinostat plus cisplatin, doxorubicin, and cyclophosphamide (PAC) has activity in thymic malignancies with a predictable adverse event profile. A Phase 2 trial is ongoing.
About Non-Hodgkin's Lymphoma
According to the National Cancer Institute (www.cancer.gov), there are expected to be 70,130 new cases of non-Hodgkin's lymphoma diagnosed and approximately 18,940 deaths in the United States in 2012. Non-Hodgkin's lymphoma is defined as any of a large group of cancers of lymphocytes (white blood cells). Non-Hodgkin's lymphomas can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss. There are many different types of non-Hodgkin's lymphoma. These types can be divided into aggressive (fast-growing) and indolent or low grade (slow-growing) types, and they can be formed from either B-cells or T-cells. Prognosis and treatment depend on the stage and type of disease.
About ZEVALIN® and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). ZEVALIN is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma who achieve a partial or complete response to first-line chemotherapy.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
Important ZEVALIN® Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration can result in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.
Please see full Prescribing Information, including BOXED WARNINGS, for ZEVALIN and rituximab. Full prescribing information for ZEVALIN can be found at www.ZEVALIN.com.
About Belinostat
Belinostat (PXD 101) is a Class I and II 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.
Belinostat is currently in a registrational trial, the BELIEF Study, under a SPA, as monotherapy for relapsed or refractory peripheral T-cell lymphoma (PTCL), an indication for which it has been granted Orphan Drug and Fast Track designations by the FDA. Belinostat is also under investigation in a randomized Phase 2 trial, as a combination therapy with carboplatin and paclitaxel, for cancer of unknown primary (CUP). The CUP study is being run and fully funded by our partner Topotarget A/S. Additionally, the National Cancer Institute is currently conducting several clinical trials of belinostat in a variety of hematological and solid tumors, both as monotherapy as well as combination therapy.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV® (levoleucovorin) for Injection and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use. In addition, Spectrum has two drugs, belinostat and apaziquone, in late-stage development and a diversified pipeline of novel drug candidates in earlier stages of development. The Company's strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. The Company has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company's website 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.®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved
