AML [2017]: Bulletin #2
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:
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?
