The drug duvelisib could improve care for some patients with difficult-to-treat leukaemia and lymphoma, according to the results of a phase III trial.
In the international DUO trial, researchers compared duvelisib with ofatumumab – an approved chemotherapy treatment – for relapsed or treatment-resistant chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
They found that duvelisib provided a median progression-free survival of 13.3 months, compared to 9.9 months with ofatumumab.
Duvelisib also appeared to benefit patients with high-risk genetic mutations and poorer prognoses, according to results published in the journal Blood.
Dr Ian W Flinn, principal investigator and Director of the Lymphoma Research Program at the Sarah Cannon Research Institute in Nashville, Tennessee, USA, said: “The way we treat patients with CLL is changing rapidly as we move from standard chemotherapy-based approaches to more targeted therapies.
“Based on these data, duvelisib may offer a new treatment option for patients who otherwise may have limited options.”
Further sub-group analysis found that among the hardest-to-treat cases, including those patients with p17 deletion or p53 abnormalities, duvelisib resulted in a 60% reduction in the risk of cancer progression or death compared to similar patients in the ofatumumab group.
Duvelisib works in two ways, first by inhibiting two kinases that are believed to help malignant B cells grow and survive, and then by disrupting the microenvironment that supports tumour growth.
The DUO trial included 319 patients with relapsed or treatment-resistant CLL or SLL who had previously received a median of two anti-cancer therapies, with one third receiving three or more. Patients were randomised to either receive twice-daily oral duvelisib or intravenous ofatumumab.
They were then followed for a median of 22.4 months. Median treatment period was 50 weeks for the duvelisib group and 23 weeks for those receiving ofatumumab.
A total of 78% in the duvelisib group experienced reductions in disease in their lymph nodes, compared with 16% of ofatumumab patients.
The most common side-effects were diarrhoea, nausea, pyrexia, neutropenia, anaemia, and cough in the duvelisib group and neutropenia and infusion reactions in the ofatumumab arm.
Source: Flinn, I.W., Hillmen, P., Montillo, M., Nagy, Z., Illés, Á., Etienne, G., Delgado, J., Kuss, B.J., Tam, C.S., Gasztonyi, Z., Offner, F., Lunin, S., Bosch, F., Davids, M.S., Lamanna, N., Jaeger, U., Ghia, P., Cymbalista, F., Portell, C.A., Skarbnik, A.P., Cashen, A.F., Weaver, D.T., Kelly, V.M., Turnbull, B., Stilgenbauer, S. (2018) “The phase 3 DUO trial: duvelisib versus ofatumumab in relapsed and refractory CLL/SLL”, Blood, available at doi: 10.1182/blood-2018-05-850461
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