Lemtrada® (alemtuzumab, formerly Campath)
Sanofi, Genzyme, and Bayer HealthCare Pharmaceuticals
- Administered in one course yearly by intravenous
infusion over three-to-five consecutive days.
The drug is a humanized monoclonal antibody
that targets a protein present on the surface of
mature lymphocytes and is approved for the
treatment of B-cell leukemia.
- This drug was granted Fast Track status by the
FDA in June 2010.
- The CAMMS223 Phase II study of 334 individuals
with early, active RRMS compared Lemtrada to
high-dose Rebif (44 mcg) in RRMS. In a threeyear
safety and efficacy trial, Lemtrada was
more effective than Rebif at reducing the
relapse rate and the risk for 60-month sustained
accumulation of disability in patients with RRMS.
In fact, the relapse rate in patients on Lemtrada
is about one attack in nine years. This is the
lowest relapse rate ever reported for an MS
drug. More than 50 percent of the Lemtradatreated
patients actually improved. Lemtrada
significantly reduced progression of brain
atrophy in the second year of treatment, and
trended toward reduction of brain atrophy over
the entire two- and three-year periods.
- In a fourth-year extension study of 334 individuals
who participated in the original CAMMS223
study, Lemtrada yielded a 73-percent reduction in
risk for sustained accumulation of disability, while
77 percent of Lemtrada-treated patients were
relapse-free. A five-year assessment showed that
87 percent were free of sustained disability
accumulation, 72 percent were relapse-free, and
65 percent were free of clinical disease activity.
These data indicate that Lemtrada's treatment
effect is durable; it halts clinical disease activity in
a significant proportion of RRMS patients through
five years, with most patients last treated with
Lemtrada at month 12 of the first year of study.
- The CARE-MS I Phase III study of 581 individuals
with RRMS was completed in April 2011. It met
one of its two primary endpoints by reducing
relapse rates by 55 percent in a two-year study
that compared two annual cycles of Lemtrada
against standard subcutaneous dosing of Rebif.
- The Phase III CARE-MS II study of 840 patients
with RRMS was completed in September 2011
and data should be released by the end of the
year. It has a similar design to CARE-MS I, but
focuses on patients who continue to have disease
activity while taking currently approved diseasemodifying
- A Phase III extension study of approximately
1,500 individuals who participated in the
CAMMS223 and the earlier Phase II CARE-MS I
and CARE-MS II studies is ongoing. Scheduled
from August 2009 to September 2014, it
examines long-term safety and efficacy in patients
who received Lemtrada, Rebif, or both in one of
the prior studies. It will also determine if and
when further Lemtrada treatment is needed, as
well as the safety and efficacy of this as-needed
- Side effects include a reduction in blood clotting,
thyroid disorders, infusion reactions, and
infection. Patients need to be monitored closely
due to risk of significant toxicities.