The 53rd annual meeting of the American Society of Hematology (ASH) will be held in San Diego, CA from December 10-13, 2011. This pre-meeting planner lists some key talks and posters scheduled for the meeting. We will be publishing a pre-meeting report early next week which will provide more detailed analyses of specific drugs and presentations.

Some highlights:

• Carfilzomib (ONXX) for multiple myeloma. A New Drug Application (NDA) was recently accepted by the FDA for carfilzomib in the treatment of multiple myeloma. While no new data from the pivotal Phase IIb study (003) is scheduled to be presented, final data from another Phase II study (004) will be presented from a similar relapsed patient group (Abstract #813) as well as data evaluating front-line carfilzomib use in combination with lenalidomide and dexamethasone (Abstract #631).
• Ponatinib (ARIA) for ALL/CML. Top-line data are expected from the pivotal Phase II – PACE trial evaluating ponatinib in refractory CML and Ph+ ALL patients (Abstract #109). Ponatinib showed impressive efficacy in a small Phase I study at the last ASH meeting, but this much larger Phase II trial will be more informative and will form the basis for regulatory submissions that could occur in the middle of 2012.
• Revlimid (CELG) for multiple myeloma. The discovery at the last ASH meeting of an increased risk of second primary malignancies (SPM) associated with Revlimid (lenalidomide) exposure has been a major issue surrounding Revlimid use. Presentation #996 analyzes pooled data from nine experimental trials and should help solidify confidence in the continued use of Revlimid as it continues to expand its role in the multiple myeloma treatment paradigm.
• Adcetris (SGEN) for Hodgkin’s lymphoma and anaplastic large cell lymphoma. Some concern was raised recently with the reporting of a second unconfirmed case of progressive multifocal leukoencephalopathy (PML) related to Adcetris (brentuximab vedotin) exposure that occurred since its FDA approval in August. Several Adcetris presentations may be opportunities to address this issue (Abstracts #443, 664, 3711). Additionally, initial data from a Phase I trial evaluating front-line Adcetris therapy will be presented (Abstract #955).
• PCI-32765 (PCYC) for non-Hodgkin’s lymphoma. PCI-32765 is an irreversible inhibitor of Bruton’s tyrosine kinase and is notable for this novel molecular target. Data should be reported from its first Phase II study evaluating its use in relapsed or refractory mantle cell lymphoma patients (Abstract #442).

If there are additional presentations or topics you would like us to follow, please inform your sales representative and we will add them to our list. Additionally, if you would like a copy of the schedule in Excel, please contact your sales representative at clientservices@pharmaintel.informa.com.

For the full report, please download the PDF version at the top of this page.

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