Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). ( 1 ) FDA label
Also known as Alemtuzumab (Campath), Alemtuzumab (Campath-1H), Lemtrada, MabCampath-1h, fludarabine phosphate, Fludara, Campath
alemtuzumab · 11 trials · 7 indications
The MRI study is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.
Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis (MS) that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation.
Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through repeated negative binomial regression with robust variance estimation and covariate adjustment for geographic region. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.
Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation without covariate adjustment.
SAD: defined as an increase of at least 1.5 points in Expanded Disability Status Scale (EDSS) score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD was estimated by Kaplan-Meier method and reported in this outcome measure. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "alemtuzumab treatment CAMMS323 extension" group and "alemtuzumab Treatment CAMMS324 Extension" group, respectively.
SAD: defined as an increase of at least 1.5 points in EDSS score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD over 2 years before and 2 years after alemtuzumab treatment were estimated by Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.
Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.
Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a \>= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.
Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The percentage of participants whose best response observed during the study was either a Complete Response (CR) or a Partial Response (PR). Overall Response (OR) = CR + PR. A Complete Response (CR) exhibits a normal physical exam, marrow cells and blood values. A Partial Response (PR) has a \>= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam.
Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes \<30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.
EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with Baseline score of 1.0 or more; and the increase persisted for at least next the 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Probability of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.
MTD: The dose at which fewer or equal to 2/6 experience a dose-limiting toxicity
| Arm | Type | Description |
|---|---|---|
| MabCampath-1h | EXPERIMENTAL | Single arm, single cohort study, all subjects will be dosed with alemtuzumab. |
| Previously treated with alemtuzumab | EXPERIMENTAL | Alemtuzumab 12 mg per day administered through IV, once a day for 3 consecutive days (participants might receive additional cycles of alemtuzumab upon documented evidence of resumed disease activity, but not within same 12-month period) |
| Previously treated with interferon beta-1a (Rebif®) | EXPERIMENTAL | Alemtuzumab 12 mg per day administered through IV, once a day for 5 consecutive days during the first cycle and 12 mg per day administered through IV, once a day for 3 consecutive days during the second cycle, 12 months later. Participants might qualify for as-needed retreatment (12 mg per day administered through IV, once a day for 3 consecutive days) after their second fixed annual cycle. |
| Alemtuzumab 12 mg | EXPERIMENTAL | Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12. |
| Alemtuzumab 24 mg | EXPERIMENTAL | Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12. |
| Interferon Beta-1a | ACTIVE_COMPARATOR | Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion. |
| Alemtuzumab | EXPERIMENTAL | - |
| Dose escalation | EXPERIMENTAL | Alemtuzumab is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg, 10mg, and 30mg administered subcutaneously (SC) (if tolerated). |
| No escalation | EXPERIMENTAL | Alemtuzumab treatment is started immediately at the 30mg dose (with no escalation period), administered subcutaneously at alternating injection sites 3 times per week for up to 18 weeks. |
| Alemtuzumab plus Fludarabine | EXPERIMENTAL | Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days. |
| Campath (alemtuzumab) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MabCampath-1h | DRUG | Drug:10 mg/mL alemtuzumab intravenous infusion. Form: Sterile, clear, colorless solution. Dosage: 2 cycles. Month 0 dosed over 5 consecutive days; month 12 dosed over 3 consecutive days. |
| alemtuzumab | BIOLOGICAL | Alemtuzumab 12 mg/day IV infusion on 5 consecutive days if the participants had no prior alemtuzumab exposure (ie, first treatment course). All subsequent treatment courses were for 3 days only. |
| Alemtuzumab 12 mg | BIOLOGICAL | Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12. |
| Alemtuzumab 24 mg | BIOLOGICAL | Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12. |
| Interferon beta-1a | BIOLOGICAL | Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion. |
| Alemtuzumab plus Fludarabine | DRUG | Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days |
| Alemtuzumab (Campath) | DRUG | An escalating dose given over 4 weeks |
| Alemtuzumab (Campath-1H) | DRUG | The investigational drug is alemtuzumab (Campath-1H). It is a recombinant humanized monoclonal antibody directed against the CD52 antigen on most (\> 95%) normal lymphocytes and T-cell and B-cell lymphomas. Alemtuzumab binds to the CD52 antigen on the cell surface, activating antibody-dependent cellular cytotoxicity, complement binding, apoptosis, cellular opsonization, and anti-tumour T-cell activity. |
Inclusion Criteria: * Signed, informed consent form * Age 18 to 50 years old (inclusive) * Diagnosis of MS per update of McDonald criteria, and cranial MRI scan demonstrating white matter lesions attributable to MS within 10 years of screening * Onset of MS symptoms within 15 years of screening * N...
Alemtuzumab is a monoclonal antibody developed by Sanofi (ticker SNY). It is being studied in B cell chronic lymphocytic leukemia, chronic graft-versus-host disease, relapsing-remitting multiple sclerosis, and peripheral T-cell lymphomas. It is an investigational therapy in Phase 3 development.
Alemtuzumab targets CD52, a protein found on the surface of certain immune cells. By binding to CD52, it acts as an inhibitor and is designed to deplete those cells. This mechanism is being evaluated in conditions including B cell chronic lymphocytic leukemia and relapsing-remitting multiple sclerosis.
Alemtuzumab is developed by Sanofi, which trades under the ticker SNY. The company is responsible for the clinical program, including the Phase 3 trials in relapsing-remitting multiple sclerosis and other indications.
Alemtuzumab is in Phase 3 clinical development. It is investigational and has not been approved by the FDA for the indications listed. The development program includes completed Phase 3 trials in relapsing-remitting multiple sclerosis and a Phase 1 trial in chronic lymphocytic leukemia.
Alemtuzumab has been studied in four completed trials. These include NCT00930553, an extension study in multiple sclerosis; NCT00548405 and NCT00530348, Phase 3 comparisons with Rebif in relapsing-remitting multiple sclerosis; and NCT00923182, a Phase 1 safety study in Japanese patients with chronic lymphocytic leukemia.
Yes, alemtuzumab is also known as Campath and Campath-1H. Other names used in research include alemtuzumab 12 mg and alemtuzumab plus fludarabine. These refer to the same monoclonal antibody developed by Sanofi.