Trial Information: A Phase I trial recruiting patients with all types of B-cell non-Hodgkin's lymphoma, including follicular lymphoma. Patients will be randomized to receive varying dosages of inotuzumab ozogamicin with rituximab, cyclophosphamide, vincristine and prednisone (R-CVP), or with rituximab, gemcitabine, dexamethasone, and cisplatinum (R-GDP). Open only to people with relapsed disease.
Background Information: Inotuzumab ozogamicine is a potentially powerful new anti-CD22 monoclonal antibody, targeting a surface protein different than of rituximab and related anti-CD20 monoclonal antibodies.
In early trials, inotuzumab showed particular promise in follicular lymphoma patients. A Japanese Phase I trial of 13 follicular lymphoma patients produced a response in 11 patients (85%), with 7 patients (54%) achieving complete remission. The new trial evaluates inotuzumab as part of combination therapy, where results may be even more striking.
Canadian Locations: Edmonton, AB; Halifax, NS; Quebec City, QC.
For more information, see ClinicalTrials.gov.
Showing posts with label Inotuzumab. Show all posts
Showing posts with label Inotuzumab. Show all posts
Friday, December 24, 2010
Tuesday, December 21, 2010
Inotuzumab Ozogamicin: Next-Generation Antibody for Follicular Lymphoma
The success of rituximab, Bexxar, and Zevalin has spawned an entire industry of monoclonal antibody research in the treatment of follicular lymphoma and related diseases. Some of the most novel of these follow Bexxar and Zevalin in combining the antibody with a useful pharmaceutical payload.
How Inotuzumab Works: Inotuzumab is an anti-CD22 antibody, attacking a different protein than the more established drugs (which mostly target CD20). Inotuzumab itself is a humanized antibody, which carries a calicheamicin antibiotic. Once the antibody binds to the cell, the antibiotic is released into the cell and kills it. Calicheamicin is one of the most powerful anti-cancer agents in our experimental arsenal today; what is lacking, outside of drug candidates like this one, is an effective way to deliver it to the target.
Like rituximab, inotuzumab targets only B cells in the immune system, meaning it can be delivered in potent amounts against cancer without the systemic side effects of older chemotherapy drugs.
Drug Status: Currently in trials.
Side Effects: Almost all patients have reduced white blood cell counts. Three-quarters also suffer from anorexia and nausea.
Response Rates: In an impressive Japanese study reported in early 2010, 13 follicular lymphoma patients who had failed previous rituximab-based therapies were given IV inotozumab daily for 28 days. Despite the fact this population was heavily pre-treated, there was an 85% response rate, including seven complete remissions (54%).
Published Studies
Michinori Ogura et al. "Phase I Study of Inotuzumab Ozogamicin (CMC-544)." Cancer Science (2010).
How Inotuzumab Works: Inotuzumab is an anti-CD22 antibody, attacking a different protein than the more established drugs (which mostly target CD20). Inotuzumab itself is a humanized antibody, which carries a calicheamicin antibiotic. Once the antibody binds to the cell, the antibiotic is released into the cell and kills it. Calicheamicin is one of the most powerful anti-cancer agents in our experimental arsenal today; what is lacking, outside of drug candidates like this one, is an effective way to deliver it to the target.
Like rituximab, inotuzumab targets only B cells in the immune system, meaning it can be delivered in potent amounts against cancer without the systemic side effects of older chemotherapy drugs.
Drug Status: Currently in trials.
Side Effects: Almost all patients have reduced white blood cell counts. Three-quarters also suffer from anorexia and nausea.
Response Rates: In an impressive Japanese study reported in early 2010, 13 follicular lymphoma patients who had failed previous rituximab-based therapies were given IV inotozumab daily for 28 days. Despite the fact this population was heavily pre-treated, there was an 85% response rate, including seven complete remissions (54%).
Published Studies
Michinori Ogura et al. "Phase I Study of Inotuzumab Ozogamicin (CMC-544)." Cancer Science (2010).
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