Campath Improves Survival of Refractory CLL Patients
Ilex (NASDAQ: ILXO) and Schering's (NYSE: SHR) Campath (Campath 1-H /
MabCampath / alemtuzumab) promoted a doubling of median survival, from 8 to
16 months, for heavily pre-treated patients with relapsed or refractory chronic lymphocytic leukemia of B-cell origin (B-CLL). Responders' survival
was extended by 32 months. Campath demonstrated encouraging data in terms of
overall objective response, median time to response, median time to progression, and overall median survival. The pivotal phase II data was
published in the May 15 issue of Blood, the Journal of the American Society
of Hematology.
The international investigation evaluated 93 heavily pre-treated B-CLL patients at 21 centers. All study subjects were previous treated with the
class of chemotherapeutics known as alkylating agents, and were refractory
to the second-line chemo, Schering's Fludara (fludarabine). After receiving
Campath for 2 to 4 weeks, clinical benefit was demonstrated by reduction in
leukemic cells circulating in the blood. After 8 to12 weeks, clinically important bone marrow effects were seen that are likely responsible for
limiting disease progression. Of the 31 Campath responders, 19 were alive 21
to 34 months post-treatment. Median survival for alkylating agent /
fludarabine-refractory patients is approximately 8-12 months, and next-line
therapies have been unable to significantly extend overall survival.
Additionally, the manuscript described encouraging preliminary data, including an 83% overall response rate, from investigation of Campath plus
Fludara combination therapy. These data suggested that the combination might
prove to be useful even for patients that relapse from and / or are refractory to either agent as monotherapy.
Campath is a monoclonal antibody that targets the CD52 protein on the surface of malignant lymphocytes. Campath is indicated for use for the
treatment of B-CLL in patients who have failed alkylating agents and fludarabine therapy. Its FDA-approval was based on its overall response rate
benefits, and not on its survival-related outcomes or other potential clinical benefits such as improvements in disease-related symptoms or
disease-free survival. These new data should promote a modest increased in
use that would accelerate with higher-powered confirmation. Another Campath
opportunity is its ongoing, phase II combination trial with IDEC (NASDAQ:
IDPH) and Genentech's (NYSE: DNA) Rituxan in relapsed or refractory CLL.
BTECH NEWS
by Leon Henderson, M.D.
Bennett Weintraub, Ph.D.
Christopher Martin
www.btechnews.com
May 15, 2002
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