Hybridoma-Derived Idiotype Vaccine for Lymphoma: Approval Must Wait
Abstract
:Introduction
Overview of the market
Institution/Sponsor | Idiotype Production | Vaccine Formulation | Disease | Biological Efficacy | Clinical Efficacy | Clinical Benefit | Reference |
---|---|---|---|---|---|---|---|
Stanford University | Hybridoma | Id-KLH + SAF-1 | FL | YES | N/A | N/A | [23] |
NCI | Hybridoma | Id-KLH + GM-CSF | MCL | YES | N/A | N/A | [37] |
NCI | Hybridoma | Id-KLH + GM-CSF | FL | YES | YES | N/A | [24] |
Puerta de Hierro Hospital | Hybridoma | Id-KLH + GM-CSF | FL | YES | YES | N/A | [25] |
University of Navarra | Hybridoma | Id-KLH + GM-CSF | FL | YES | N/A | YES | [26] |
Biovest | Hybridoma/AutovaxId/BiovaxId | Id-KLH + GM-CSF | FL | pending | pending | YES | [31] |
Introduction to the Compound
Chemistry
Pharmacodynamics
Pharmacokinetics and Metabolism
Clinical efficacy and benefit
Variable | Planned | Actual |
---|---|---|
Accrual | 629 (later revised to 563) pts | 234 pts |
Randomization | 375 pts | 177 (later reduced to 117 on a modified ITT basis) pts |
Vaccinated (5 doses) | 250 pts | 76 pts (at least 1 dose) |
Control product | 125 pts | 41 pts |
Required statistical significance (difference in RFS) | p < 0.01 | p = 0.045 |
Safety and Tolerability
Regulatory affairs
Pre-Vaccine Therapy | Patient Status Before Vaccination | Accrual (planned / actual) | Endpoint | Results (required / obtained) | Reference |
---|---|---|---|---|---|
CVP (8 cycles) | First CR or PR | 360 / 285 | PFS | p < 0.01 / p = n.s. | 34 |
Rituximab (4 doses) | First CR or PR or SD | 342 / 345 | TTP | p < 0.01 / p = n.s. | 35 |
PACE (90% of pts) or Rituximab-CHOP (6 cycles) | First CR | 375 / 117 (modified ITT) | DFS | p < 0.01 / p = 0.045 | 31 |
Conclusions
References
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Bendandi, M. Hybridoma-Derived Idiotype Vaccine for Lymphoma: Approval Must Wait. Pharmaceuticals 2010, 3, 667-678. https://doi.org/10.3390/ph3030667
Bendandi M. Hybridoma-Derived Idiotype Vaccine for Lymphoma: Approval Must Wait. Pharmaceuticals. 2010; 3(3):667-678. https://doi.org/10.3390/ph3030667
Chicago/Turabian StyleBendandi, Maurizio. 2010. "Hybridoma-Derived Idiotype Vaccine for Lymphoma: Approval Must Wait" Pharmaceuticals 3, no. 3: 667-678. https://doi.org/10.3390/ph3030667