AML [2017]: Bulletin #2

July 2017 | - | ID: A52C8C16265EN
FirstWord

Abstracts

This update bulletin edition presents US and EU key opinion leader (KOL) views on recent developments in the acute myeloid leukaemia (AML) space. Topics covered include expert opinions on; Seattle Genetics reporting the termination of the Phase III CASCADE study with its anti-CD33 agent vadastuximab talirine (SGN-CD33A) as a front-line approach in older patients with AML; the FDA’s Oncologic Drugs Advisory Committee (ODAC) granting a positive review of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in patients with previously untreated, de novo AML; and final Phase I/II results from the CHRYSALIS study with Astellas’ FLT3/AXL kinase inhibitor gilteritinib (ASP2215) which were published recently in the Lancet Oncology.

Business Questions:

• How do KOLs view the termination of the Phase III CASCADE trial with Seattle Genetics’ vadastuximab talirine?
• What is the future potential for vadastuximab talirine in AML?
• What are KOL reactions to the ODAC’s positive vote to recommend the approval of Pfizer’s Mylotarg in previously untreated, de novo AML patients?
• To what extent is the ALFA-0701 trial considered compelling evidence in support of Mylotarg?
• What are KOL opinions on the proposed lower dosing of Mylotarg?
• To what extent are KOLs impressed by the results from the CHRYSALIS study of Astellas’ gilteritinib?
• Are KOLs concerned by the adverse event risk in the CHRYSALIS trial?
• If gilteritinib were to be approved in AML, in which patient types would KOLs consider use?