AstraZeneca says Calquence combination improved survival in leukemia patients
AstraZeneca presented results from the interim analysis of the Phase III Elevate TN trial, showing that Calquence combined with obinutuzumab or as monotherapy significantly improved progression-free survival compared to chlorambucil plus obinutuzumab, a standard chemo-immunotherapy treatment, in patients with previously untreated chronic lymphocytic leukemia. At a median follow-up of 28.3 months, Calquence in combination with obinutuzumab or as a monotherapy "significantly reduced" the risk of disease progression or death by 90% and 80%, respectively, versus chlorambucil plus obinutuzumab, AstraZeneca said in a statement. In an exploratory analysis, Calquence in combination or alone demonstrated consistent PFS improvements across most pre-specified subgroups of patients with high-risk disease characteristics, including the unmutated immunoglobulin heavy-chain variable gene, del(11q) and complex karyotype, it added. Overall, the safety and tolerability profile of Calquence observed in the trial was consistent with its known profile, according to AstraZeneca.