51st ASH Annual Meeting & Exposition December 5-8, 2009
I would first like to thank my Italian friend, Albatros, for posting this information on my blog. As I understand, all documents related to upcoming ASH presentations were scheduled to be released on Tuesday, November 10, 2009 at 12:00 AM ET.
IMPRESSIVE RESULTS This year, Zevalin® will be featured in 11 presentations at this year's annual meeting. That's impressive. Zevalin is now marketed by Spectrum Pharmaceuticals (SPPI) for the first-line consolidation treatment for non-Hodgkin's lymphoma (NHL).
Below are the titles and conclusions of the 11 abstracts that will be presented at this year's annual ASH meeting. This year the annual meeting will begin on Saturday, December 5 and end on Tuesday, December 8, 2009. Interested investors can view all abstracts and posters featuring Zevalin here.
THE RESULTS
868 Stem Cell Transplantation with 90yttrium Ibritumomab Tiuxetan (90YIT) in Non-Hodgkin’s Lymphoma (NHL): Observations From PET Pre-Treatment Imaging and Responses in Allografted Refractory Follicular Histologies
Conclusions: These data provide evidence that combining 90YIT at 0.4mCI/kg with the conditioning improves outcomes in NHL pts undergoing AUTO or NST, but not in CLL. Our results also represent the first report showing that the combination may overcome the negative prognostic value of PET+ in NHL, and that the addition of 90YIT to NST conditioning can induce long-term remission in relapsed refractory FL without added toxicity. Verification of our results in a larger cohort of pts is highly warranted.
932 90y-Ibritumumab Tiuxetan (Zevalin ®)-BEAM/C with Autologous Stem Cell Support as Frontline Therapy for Advanced Mantle Cell Lymphoma. – Preliminary Results From the Third Nordic MCL Phase II Study (MCL3)
Conclusions: The high response rates after induction treatment achieved in the MCL2 study are confirmed in the present study. Adding 90Y-Ibritumomab tiuxetan to high-dose chemotherapy for responding patients not in CR prior to transplant is feasible and does not increase toxicity. A negative PET-scan prior to transplant predicts for a molecular remission after the transplant.
3210 90y-Ibritumomab Tiuxetan or Purine Analogues Severely Affect Peripheral Blood Stem Cell Mobilization: An Analysis on 248 Patients
Conclusions: These results could help to identify those factors affecting PBSC mobilization. To reduce poor mobilizers we suggest to anticipate mobilization program and to evaluate the opportunity to reserve purine analogs or radioimmunotherapy after collection. About 20% of patients defined as absolute poor mobilizers might successfully mobilize PBSC by lowering the CD34+ cut-off before apheresis.
2720 A Phase 2 Trial of Rituximab-CHOP Chemotherapy Followed by Yttrium 90 (90Y) Ibritumomab Tiuxetan (90Y-IT) for Previously Untreated Elderly Diffuse Large B-Cell Lymphoma (DLBCL) Patients
Conclusions: These preliminary data indicate that radioimmunotherapy appears highly effective and feasible as “consolidation” after 4 cycles of immunochemotherapy in elderly DLBCL patients, improving quality of response without any cumulative toxicity.
1703 Feasability and Toxicity after Induction Treatment with Rituximab-HCVAD and Metotrexate/Citarabine, Followed by Consolidation with Y-90 Ibritumomab Tiuxetan (Phase II GELTAMO–LCM 04-02 study)
Conclusions: Treatment of MCL with 6 cycles of Hyper-CVAD/MTX-AraC with anti-CD20 can be accomplished in 70% of the patients up to 70 years, although close follow-up and dose adjustments are frequently required mainly due to haematological toxicity. Consolidation with Ibritumomab-tiuxetan is safe and feasible at a dose of 0,3 mCi/Kg. Efficacy is high with an ORR and PFS of 83% and 75%, respectively although longer follow-up is needed to evaluate the role of consolidation treatment with RIT.
335790y-Ibritumomab Tiuxetan (Zevalin®) May Enhance Anti-Lymphoma Effect of Reduced-Intensity Fludarabine and Melphalan Regimen in Patients with Relapsed, Refractory B-Cell Non-Hodgkin Lymphoma (NHL) Undergoing Allogeneic Hematopoietic Cell Transplant (Allo-HCT
Conclusions: This study demonstrates the feasibility, tolerability and efficacy of adding Zevalin® to RIC fludarabine and melphalan in the allo-HCT setting for B-cell NHL. The response observed at 1 month post-transplant in patients with refractory disease are encouraging and suggest that this approach could be used to provide early disease control before graft-versus lymphoma effect takes place.
3538 No Harmful Impact of 90Yttrium-Ibritumomab Tiuxetan Combined with BEAM on Bone Marrow Microenvironment
Conclusions: 90Y-ibritumomab tiuxetan alone did not effect the bone marrow environment as measured by SDF-1α and HA. As expected, significant changes were found after high dose chemotherapy. Engraftment and repopulation after Z-BEAM and auSCT was similar to standard BEAM followed by auSCT.
3743 A Phase II Trial of R-FM (Rituximab, Fludarabine and Mitoxantrone) Chemotherapy Followed by Yttrium 90 (90Y) Ibritumomab Tiuxetan (90Y-IT) for Untreated Follicular Lymphoma (FL) Patients
Conclusions: These preliminary data indicate that radioimmunotherapy appears highly effective and feasible as “consolidation” after short (4 cycles) immunochemotherapy in FL patients, improving quality of response without any cumulative toxicity.
3751 Phase II Trial of 90y-Ibritumomab Tiuxetan Treatment as Consolidation After 6th R-CHOP Chemotherapy in Patients with Limited-Stage, Bulky Diffuse Large B Cell Lymphoma
Conclusions: Consolidation treatment with Ibritumomab tuixetan resulted in a favorable response with tolerable toxicity in patients with bulky DLBCL.
3746 Consolidation with Radioimmunotherapy May Prolong Survival in First Remission of Mantle Cell Lymphoma Patients Uneligible for Stem Cell Transplantation, an Analysis of the International RIT-Network
Conclusions: Standard-dose non-myeloablative RIT is a feasible and safe treatment modality, even for elderly MCL pts. Consolidation radioimmunotherapy with ibritumomab tiuxetan may prolong survival of patients who achieved clinical response after chemotherapy. Therefore, this consolidation approach should be considered as a treatment strategy for those, who are not eligible for ASCT. RIT also has a potential role as a palliation therapy in relapsing/resistant cases.
3423 Y90 Plus High Dose BEAM with Autologous Stem Cell Transplantation for Chemorefractory Non Hodgkin Lymphoma
Conclusions: In this poor risk group of patients Y90 plus high dose BEAM can induce responses and long term remissions, however, for patients with chemorefractory MCL other treatment approaches may be warranted.
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Spectrum Pharma: Zevalin's Impressive Results to Be Presented at ASH 2009 0 comments
December 5-8, 2009
I would first like to thank my Italian friend, Albatros, for posting this information on my blog. As I understand, all documents related to upcoming ASH presentations were scheduled to be released on Tuesday, November 10, 2009 at 12:00 AM ET.
IMPRESSIVE RESULTS
This year, Zevalin® will be featured in 11 presentations at this year's annual meeting. That's impressive. Zevalin is now marketed by Spectrum Pharmaceuticals (SPPI) for the first-line consolidation treatment for non-Hodgkin's lymphoma (NHL).
Below are the titles and conclusions of the 11 abstracts that will be presented at this year's annual ASH meeting. This year the annual meeting will begin on Saturday, December 5 and end on Tuesday, December 8, 2009. Interested investors can view all abstracts and posters featuring Zevalin here.
THE RESULTS
Conclusions: These data provide evidence that combining 90YIT at 0.4mCI/kg with the conditioning improves outcomes in NHL pts undergoing AUTO or NST, but not in CLL. Our results also represent the first report showing that the combination may overcome the negative prognostic value of PET+ in NHL, and that the addition of 90YIT to NST conditioning can induce long-term remission in relapsed refractory FL without added toxicity. Verification of our results in a larger cohort of pts is highly warranted.
932 90y-Ibritumumab Tiuxetan (Zevalin ®)-BEAM/C with Autologous Stem Cell Support as Frontline Therapy for Advanced Mantle Cell Lymphoma. – Preliminary Results From the Third Nordic MCL Phase II Study (MCL3)
Conclusions: The high response rates after induction treatment achieved in the MCL2 study are confirmed in the present study. Adding 90Y-Ibritumomab tiuxetan to high-dose chemotherapy for responding patients not in CR prior to transplant is feasible and does not increase toxicity. A negative PET-scan prior to transplant predicts for a molecular remission after the transplant.
3210 90y-Ibritumomab Tiuxetan or Purine Analogues Severely Affect Peripheral Blood Stem Cell Mobilization: An Analysis on 248 Patients
Conclusions: These results could help to identify those factors affecting PBSC mobilization. To reduce poor mobilizers we suggest to anticipate mobilization program and to evaluate the opportunity to reserve purine analogs or radioimmunotherapy after collection. About 20% of patients defined as absolute poor mobilizers might successfully mobilize PBSC by lowering the CD34+ cut-off before apheresis.
2720 A Phase 2 Trial of Rituximab-CHOP Chemotherapy Followed by Yttrium 90 (90Y) Ibritumomab Tiuxetan (90Y-IT) for Previously Untreated Elderly Diffuse Large B-Cell Lymphoma (DLBCL) Patients
Conclusions: These preliminary data indicate that radioimmunotherapy appears highly effective and feasible as “consolidation” after 4 cycles of immunochemotherapy in elderly DLBCL patients, improving quality of response without any cumulative toxicity.
1703 Feasability and Toxicity after Induction Treatment with Rituximab-HCVAD and Metotrexate/Citarabine, Followed by Consolidation with Y-90 Ibritumomab Tiuxetan (Phase II GELTAMO–LCM 04-02 study)
Conclusions: Treatment of MCL with 6 cycles of Hyper-CVAD/MTX-AraC with anti-CD20 can be accomplished in 70% of the patients up to 70 years, although close follow-up and dose adjustments are frequently required mainly due to haematological toxicity. Consolidation with Ibritumomab-tiuxetan is safe and feasible at a dose of 0,3 mCi/Kg. Efficacy is high with an ORR and PFS of 83% and 75%, respectively although longer follow-up is needed to evaluate the role of consolidation treatment with RIT.
3357 90y-Ibritumomab Tiuxetan (Zevalin®) May Enhance Anti-Lymphoma Effect of Reduced-Intensity Fludarabine and Melphalan Regimen in Patients with Relapsed, Refractory B-Cell Non-Hodgkin Lymphoma (NHL) Undergoing Allogeneic Hematopoietic Cell Transplant (Allo-HCT
Conclusions: This study demonstrates the feasibility, tolerability and efficacy of adding Zevalin® to RIC fludarabine and melphalan in the allo-HCT setting for B-cell NHL. The response observed at 1 month post-transplant in patients with refractory disease are encouraging and suggest that this approach could be used to provide early disease control before graft-versus lymphoma effect takes place.
3538 No Harmful Impact of 90Yttrium-Ibritumomab Tiuxetan Combined with BEAM on Bone Marrow Microenvironment
Conclusions: 90Y-ibritumomab tiuxetan alone did not effect the bone marrow environment as measured by SDF-1α and HA. As expected, significant changes were found after high dose chemotherapy. Engraftment and repopulation after Z-BEAM and auSCT was similar to standard BEAM followed by auSCT.
3743 A Phase II Trial of R-FM (Rituximab, Fludarabine and Mitoxantrone) Chemotherapy Followed by Yttrium 90 (90Y) Ibritumomab Tiuxetan (90Y-IT) for Untreated Follicular Lymphoma (FL) Patients
Conclusions: These preliminary data indicate that radioimmunotherapy appears highly effective and feasible as “consolidation” after short (4 cycles) immunochemotherapy in FL patients, improving quality of response without any cumulative toxicity.
3751 Phase II Trial of 90y-Ibritumomab Tiuxetan Treatment as Consolidation After 6th R-CHOP Chemotherapy in Patients with Limited-Stage, Bulky Diffuse Large B Cell Lymphoma
Conclusions: Consolidation treatment with Ibritumomab tuixetan resulted in a favorable response with tolerable toxicity in patients with bulky DLBCL.
3746 Consolidation with Radioimmunotherapy May Prolong Survival in First Remission of Mantle Cell Lymphoma Patients Uneligible for Stem Cell Transplantation, an Analysis of the International RIT-Network
Conclusions: Standard-dose non-myeloablative RIT is a feasible and safe treatment modality, even for elderly MCL pts. Consolidation radioimmunotherapy with ibritumomab tiuxetan may prolong survival of patients who achieved clinical response after chemotherapy. Therefore, this consolidation approach should be considered as a treatment strategy for those, who are not eligible for ASCT. RIT also has a potential role as a palliation therapy in relapsing/resistant cases.
3423 Y90 Plus High Dose BEAM with Autologous Stem Cell Transplantation for Chemorefractory Non Hodgkin Lymphoma
Conclusions: In this poor risk group of patients Y90 plus high dose BEAM can induce responses and long term remissions, however, for patients with chemorefractory MCL other treatment approaches may be warranted.
Disclosure: Long SPPI.
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