Scientists in the United States have said that patients suffering from relapsed or refractory chronic lymphocytic leukemia (CLL) are responding well to a new peptide vaccine.

In clinical trials, the addition of leukemia vaccine Oblimersen (Genasense) to chemotherapy produced a significant improvement in long-term survival in patients with relapsed or refractory chronic lymphocytic leukemia compared with chemotherapy alone.

The findings were reported at the 49th annual meeting of the American Society of Hematology in Atlanta, the United States.

Researchers at the M D Anderson Cancer Center at the University Texas, the United States, said immune response to the PR1 vaccine was associated with an 8.7-month, event-free survival compared with 2.4 months for non-responders. Clinical responses ranged from improvements in blood counts to complete cytogenetic remission.

The Phase I/II clinical trial was designed to assess the vaccine’s safety and ability to elicit an immune response. Toxicity was limited to low-grade injection site side effects such as redness, swelling, and some pain.

After 54 months of follow-up, survival was 10% with oblimersen versus 2% with chemotherapy alone (P=0.017), Dr Susan O’Brien, of the University of Texas M D Anderson Cancer Center in Houston, who led the research, told the meeting of the American Society of Hematology.

More than twice as many patients treated with oblimersen, which is not yet approved by the United States Food and Drug Administration (FDA), had complete responses, and duration of response was more than a year greater compared with chemotherapy alone.

Dr Susan O’Brien said, “In a relapsed population, that is excellent survival. The findings also show that response is an appropriate endpoint for these patients because response to therapy is associated with improved survival.”

Media reports said that disease-specific Phase II clinical trials of the vaccine for chronic myelogenous leukemia and myelodysplastic syndrome have been either planned or are under way.

The company that makes the vaccine Oblimersen is conducting a Phase III clinical trial across the United States for acute myelogenous leukemia.

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