Spectrum (SPPI) Updates on ZEVALIN at ASCO; FIve Poster Presentations Show Strong Results
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Spectrum Pharmaceuticals (Nasdaq: SPPI), 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:
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.
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.
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.
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