We had a very busy week in Atlanta, Georgia in the USA recently delivering a number of projects for our clients during the American Society of Haematology Annual Meeting and Exposition (ASH), held on December 8-11 2012. We filmed and interviewed experts discussing the latest developments across across a range of blood cancers, as well as hosting a number of expert panel discussions in multiple myeloma, chronic lymphocytic leukaemia and non-Hodgkin lymphoma.
Some of the latest research and therapies in the evolving field of haematology were presented during ASH Annual Meeting, with exciting new agents appearing in the field of multiple myeloma include carfilzomib (recently approved) and pomalidomide (pending approval) both for use in the relapsed/refractory setting. The latter is a next-generation immunomodulatory agent. The Phase II data for pomalidomide in combination with low-dose dexamethasone (LoDex) (MM-002 trial) was so encouraging that it has filed for accelerated approval in the USA and conditional approval in Europe. Impressive preliminary data from the Phase III NIMBUS study (MM-003; NCT01311687) demonstrated that pomalidomide plus LoDEX significantly improved progression free survival compared to high-dose dexamethasone.
Other agents also showing potential with new mechanisms of action include ARRY-520, elotuzumab and tabalumab. ARRY-520 is a kinesin spindle protein inhibitor which has demonstrated activity in combination with dexamethasone in heavily pretreated myeloma patients, and its activity in combination carfilzomib or bortezomib are currently being investigated in Phase I trials. Elotuzumab is a humanised monoclonal antibody (targets cell surface glycoprotein CS1) that favourably improved the action of lenalidomide plus dexamethasone in Phase II trials. Phase III trials of the combination are now underway. Tabalumab is a another monoclonal antibody that targets the membrane-bound and soluble B cell activating factor and is showing encouraging results in Phase I studies in combination with bortezomib in the relapsed setting. However, further trials are needed to assess the true value of this agent.
Elderly patients newly diagnosed with acute myeloid leukaemia tend to have a poor prognosis and lack of therapeutic options. However new treatments are emerging for these patients. Decitabine was recently approved in Europe (although not in the USA) and Phase III trials of both sapacitabine and vidaza are ongoing. Positive Phase II data also suggests that two new targeted agents – quizartinib (a selective FLT3 inhibitor) and volasertib (an inhibitor of Polo-like kinase 1) may be efficacious in this population and are poised to enter Phase III development within the next year.
Bendamustine plus rituximab initially appeared to offer a more effective and less toxic regimen than the standard R-CHOP for patients with indolent lymphomas. The combination has been studied in two Phase III trials: the German Study Group Indolent Lymphomas (StiL) NHL 1 study and the US BRIGHT study. Overall, bendamustine plus rituximab is non-inferior to R-CHOP/R-CVP in patients with advanced indolent non-Hodgkin’s lymphomas and mantle cell lymphoma. However, concerns about discrepancies in safety and efficacy outcomes reported in StiL and BRIGHT mean that more follow up data is needed before bendamustine approval in the front line setting can be considered.
Finally, Pharmacyclic and Janssen’s ibrutinib seized centre stage with promising results for CLL patients who were both treatment naïve and unresponsive to other treatments. Investigators concluded that 71% of untreated patients demonstrated a complete or partial response, compared to 67% of a group of relapsed patients and half of the elderly subjects in a particularly high-risk cohort. And after nearly two years of follow-up, the disease had not progressed in 96% of the previously untreated group, compared to 76% of the relapsed and high-risk patients. The trial also highlighted the drug’s promising ability to treat the disease without inflicting older patients with severe toxicity.
In another study, ibrutinib combined with Rituximab was effective in 83% of patients with 38 of the 40 patients in that trial continuing without disease progression after three and six months of follow-up.
The development of these new agents for these haematological malignancies has been warmly welcomed by physicians attending this year’s ASH meeting and outcomes from studies investigating newer therapies are eagerly awaited.
You can see the full ASH 2012 video highlights on ecancer.tv