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Long-Term Survival With Mylotarg/Transplant in AML

Long-Term Survival With Mylotarg/Transplant in AML

PHILADELPHIA—Remissions induced by gemtuzumab ozogamicin (Mylotarg)
monotherapy in patients with first-relapse acute myeloid leukemia (AML) can
be prolonged with subsequent therapy. Allogeneic hematopoietic stem cell
transplant was particularly effective and even produced some long-term
remissions in patients who did not respond to gemtuzumab, Eric Sievers, MD,
reported at the 44th Annual Meeting of the American Society of Hematology
(ASH abstract 327).

Not a Randomized Trial

The combination of gemtuzumab with allogeneic stem cell transplant appears
highly efficacious in patients with first-relapse AML, "with the caveat that
this is not a randomized trial, but an observational study of what physicians
chose to do with their monotherapy patients in remission," said Dr. Sievers,
assistant member, Clinical Research Division, Fred Hutchinson Cancer Research
Center.

Allogeneic transplant was relatively safe in patients previously exposed
to gemtuzumab, and more than 50% of patients who achieved remission with the
combined treatments are alive 2 years post-transplant.

The prognosis for first-relapse AML is historically poor, with response
rates to conventional agents of about 30% to 50% and a 6-month median
duration of the second remission. Chemotherapy agents are also associated
with considerable nonhematologic toxicity.

Dr. Sievers presented long-term follow-up data on patients enrolled in
three clinical trials of gemtuzumab, an antibody-targeted chemotherapy
consisting of a humanized anti-CD33 antibody linked to calicheamicin, a
cytotoxic antibiotic. CD33 is expressed by leukemic blasts in 80% to 90% of
patients with AML and is absent from stem cells and nonhematologic tissues,
reducing the potential for nonhematologic toxicity.

The aim of the analysis was to determine the best follow-up therapy for
patients with relapsed AML treated with gemtuzumab monotherapy. The three
multinational trials enrolled a total of 277 patients, all with CD33-positive
disease in first untreated relapse.

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