12 August 2019

People with chronic lymphocytic leukaemia (CLL) stay disease-free and alive for longer when they are treated with a combination of two drugs, according to an interim analysis of a phase 3 clinical trial.

The trial, carried out by researchers at Stanford Medicine, California, USA, and other institutions, could result in changes to treatment of the disease – reducing requirements for chemotherapy, researchers say.

Dr Tait Shanafelt, Professor of Medicine at Stanford and lead author of the study, said “these results will fully usher the treatment of chronic lymphocytic leukaemia into a new era.”

The new drug combination pairs rituximab with ibrutinib, two drugs which specifically target B cells. “We've found that this combination of targeted treatments is both more effective and less toxic than the previous standard of care for these patients”, Dr Shanafelt said. “It seems likely that, in the future, most patients will be able to forego chemotherapy altogether.”

In the trial, 529 people with newly diagnosed CLL were randomly assigned in a 2:1 ratio to receive either six courses of ibrutinib and rituximab followed by ibrutinib until their disease progressed, or six courses of standard treatment consisting of fludarabine, cyclophosphamide and rituximab.

The results, which are published in the New England Journal of Medicine, found that 89.4% of participants who received the experimental drug combination had still not had leukaemia progression about three years later, compared to 72.9% of those who received the traditional chemotherapy combination.

There was also a statistically significant difference in overall survival between the two groups: 98.8% of the people randomly assigned to receive the new drug combination were alive after three years, compared with 91.5% of those who had received the traditional treatment. However, longer follow-up is needed to confirm the difference in overall survival between the two groups.

Dr Shanafelt said: “This is one of those situations we don't often have in oncology. The new treatment is both more effective and better tolerated. This represents a paradigm shift in how these patients should be treated. We can now relegate chemotherapy to a fallback plan rather than a first-line course of action.”

Source: Shanafelt, T.D., Wang, X.V., Kay, N.E., Hanson, C.A., O'Brien, S., Barrientos, J., Jelinek, D.F., Braggio, E., Leis, J.F., Zhang, C.C., Coutre, S.E., Barr, P.M., Cashen, A.F., Mato, A.R., Singh, A.K., Mullane, M.P., Little, R.F., Erba, H., Stone, R.M., Litzow, M., Tallman, M. (2019) “Ibrutinib–Rituximab or Chemoimmunotherapy for Chronic Lymphocytic Leukemia”, New England Journal of Medicine, available from doi: 10.1056/NEJMoa1817073


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