Spectrum Pharmaceuticals announced independent researchers from leading universities in Germany, Austria, Italy, and Sweden, reported early positive results from the first Phase 2 clinical trial evaluating treatment-naïve patients with follicular non-Hodgkin’s lymphoma (NHL) treated with ZEVALIN (ibritumomab tiuxetan) injection for intravenous use as a monotherapy
ORLANDO, FL, USA | December 6, 2010 | Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced independent researchers from leading universities in Germany, Austria, Italy, and Sweden, reported early positive results from the first Phase 2 clinical trial evaluating treatment-naïve patients with follicular non-Hodgkin’s lymphoma (NHL) treated with ZEVALIN (ibritumomab tiuxetan) injection for intravenous use as a monotherapy. This trial differed from earlier ZEVALIN trials in NHL in that patients were treated with ZEVALIN first-line, without the use of upfront chemotherapy. The data were presented at an oral session at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.
Antonio Pezzutto, M.D., Professor of Hematology and Oncology at Charité Hospital, Berlin and principal investigator for the study, designed it to assess whether any chemotherapy is necessary before administering ZEVALIN for patients with Stage III and IV follicular NHL. The preliminary results from this 60-patient, single-arm study show that treatment-naïve patients who received a single dose of ZEVALIN alone achieved a one-year overall clinical response rate of 84% (53% complete response and 31% partial response). This response is of similar magnitude to responses reported in previous trials evaluating standard chemotherapy alone, or chemotherapy followed by ZEVALIN, in NHL. Because no chemotherapy was used in the current trial, patients were not exposed to the often serious adverse events associated with it. Professor Pezzutto and colleagues concluded the absence of infectious episodes and limited severity of side effects compare extremely well with the toxicity of the standard regimens.
"The strongest argument in favor of ZEVALIN is the patients’ acceptance: most patients do not have the impression of being treated for cancer," said Professor Pezzutto of Charité Hospital, Humboldt University, Berlin.
Longer follow-up of the same patient cohort will yield data on the duration of response (progression-free survival). In the trial, hematological toxicity was modest: 24 patients exhibited thrombocytopenia, neutropenia and/or anemia. To date, progression to high-grade lymphoma occurred in three patients. The safety profile was comparable to that seen with ZEVALIN’s use in approved indications, but patients in this trial were spared the side effects associated with upfront chemotherapy.
ZEVALIN is currently indicated for untreated NHL, in patients who achieve a partial or complete response to first-line chemotherapy. ZEVALIN is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL.
"The first-ever data suggesting strong clinical activity of ZEVALIN as a monotherapy in the first-line setting for selected lymphoma patients gives us a green light to pursue a clinical program as part of our strategy to expand the label of FDA-approved uses of the radioimmunotherapy," said Rajesh C. Shrotriya, M.D., Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. "We plan to make this potential indication a part of our long-term strategy to expand commercial use of ZEVALIN. We are currently consulting leading hematologists and regulatory advisors to create a development plan."
Professor Pezzutto’s ASH presentation is titled 90Yttrium Ibritumomab Tiuxetan as First Line Treatment for Follicular Lymphoma: First Results from an International Phase II Clinical Trial. ASH abstract # 593.
About ZEVALIN®
ZEVALIN (ibritumomab tiuxetan) injection for intravenous use is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of three components: rituximab, Indium-111 (In-111) radiolabeled ZEVALIN for imaging, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. The ZEVALIN therapeutic regimen is a form of cancer therapy called radioimmunotherapy. Radioimmunotherapy (RIT) is an innovative form of cancer treatment with a mechanism of action that is different from traditional chemotherapy. RIT builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
Full prescribing information can be found at www.ZEVALIN.com.
Important ZEVALIN(R) 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 results 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. Patients and healthcare professionals can visit http://www.ZEVALIN.com for more information.
About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms: aggressive NHL, a rapidly spreading acute form of the disease; and indolent NHL, which progresses more slowly. Follicular lymphoma is a type of indolent lymphoma. According to the National Cancer Institute’s SEER database (http://seer.cancer.gov/statfacts/html/nhl.html) there were approximately 419,533 patients alive with a history of NHL. According to the American Cancer Society, NHL is one of the most common cancers in the United States, accounting for approximately 4% of all cancers. In 2010, an estimated 65,540 people will be diagnosed and approximately 20,210 people will die from the disease.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. 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.
SOURCE: Spectrum Pharmaceuticals, Inc.
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Spectrum Pharmaceuticals announced independent researchers from leading universities in Germany, Austria, Italy, and Sweden, reported early positive results from the first Phase 2 clinical trial evaluating treatment-naïve patients with follicular non-Hodgkin’s lymphoma (NHL) treated with ZEVALIN (ibritumomab tiuxetan) injection for intravenous use as a monotherapy
ORLANDO, FL, USA | December 6, 2010 | Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced independent researchers from leading universities in Germany, Austria, Italy, and Sweden, reported early positive results from the first Phase 2 clinical trial evaluating treatment-naïve patients with follicular non-Hodgkin’s lymphoma (NHL) treated with ZEVALIN (ibritumomab tiuxetan) injection for intravenous use as a monotherapy. This trial differed from earlier ZEVALIN trials in NHL in that patients were treated with ZEVALIN first-line, without the use of upfront chemotherapy. The data were presented at an oral session at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.
Antonio Pezzutto, M.D., Professor of Hematology and Oncology at Charité Hospital, Berlin and principal investigator for the study, designed it to assess whether any chemotherapy is necessary before administering ZEVALIN for patients with Stage III and IV follicular NHL. The preliminary results from this 60-patient, single-arm study show that treatment-naïve patients who received a single dose of ZEVALIN alone achieved a one-year overall clinical response rate of 84% (53% complete response and 31% partial response). This response is of similar magnitude to responses reported in previous trials evaluating standard chemotherapy alone, or chemotherapy followed by ZEVALIN, in NHL. Because no chemotherapy was used in the current trial, patients were not exposed to the often serious adverse events associated with it. Professor Pezzutto and colleagues concluded the absence of infectious episodes and limited severity of side effects compare extremely well with the toxicity of the standard regimens.
"The strongest argument in favor of ZEVALIN is the patients’ acceptance: most patients do not have the impression of being treated for cancer," said Professor Pezzutto of Charité Hospital, Humboldt University, Berlin.
Longer follow-up of the same patient cohort will yield data on the duration of response (progression-free survival). In the trial, hematological toxicity was modest: 24 patients exhibited thrombocytopenia, neutropenia and/or anemia. To date, progression to high-grade lymphoma occurred in three patients. The safety profile was comparable to that seen with ZEVALIN’s use in approved indications, but patients in this trial were spared the side effects associated with upfront chemotherapy.
ZEVALIN is currently indicated for untreated NHL, in patients who achieve a partial or complete response to first-line chemotherapy. ZEVALIN is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL.
"The first-ever data suggesting strong clinical activity of ZEVALIN as a monotherapy in the first-line setting for selected lymphoma patients gives us a green light to pursue a clinical program as part of our strategy to expand the label of FDA-approved uses of the radioimmunotherapy," said Rajesh C. Shrotriya, M.D., Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. "We plan to make this potential indication a part of our long-term strategy to expand commercial use of ZEVALIN. We are currently consulting leading hematologists and regulatory advisors to create a development plan."
Professor Pezzutto’s ASH presentation is titled 90Yttrium Ibritumomab Tiuxetan as First Line Treatment for Follicular Lymphoma: First Results from an International Phase II Clinical Trial. ASH abstract # 593.
About ZEVALIN®
ZEVALIN (ibritumomab tiuxetan) injection for intravenous use is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of three components: rituximab, Indium-111 (In-111) radiolabeled ZEVALIN for imaging, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. The ZEVALIN therapeutic regimen is a form of cancer therapy called radioimmunotherapy. Radioimmunotherapy (RIT) is an innovative form of cancer treatment with a mechanism of action that is different from traditional chemotherapy. RIT builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
Full prescribing information can be found at www.ZEVALIN.com.
Important ZEVALIN(R) 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 results 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. Patients and healthcare professionals can visit http://www.ZEVALIN.com for more information.
About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms: aggressive NHL, a rapidly spreading acute form of the disease; and indolent NHL, which progresses more slowly. Follicular lymphoma is a type of indolent lymphoma. According to the National Cancer Institute’s SEER database (http://seer.cancer.gov/statfacts/html/nhl.html) there were approximately 419,533 patients alive with a history of NHL. According to the American Cancer Society, NHL is one of the most common cancers in the United States, accounting for approximately 4% of all cancers. In 2010, an estimated 65,540 people will be diagnosed and approximately 20,210 people will die from the disease.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. 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.
SOURCE: Spectrum Pharmaceuticals, Inc.
Post Views: 89
