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Acute Myeloid Leukaemia (AML): Update Bulletin #1 [May 2018]

Product Code:
Publication Date:
May 2018

This edition presents the views and insights from three world leading key opinion leaders (KOLs) from North America and Europe on a variety of recent events in the Acute Myeloid Leukaemia (AML) market, including;  SELLAS Life Sciences Group publishing Phase II data, investigating its Wilms Tumour 1 (WT1) peptide vaccine galinpepimut-S (GPS) in patients with AML in first complete remission; GlycoMimetics announcing that it will initiate a randomised Phase III trial to evaluate its E-selectin antagonist GMI-1271 in combination with standard chemotherapy in patients with relapsed/refractory AML; and Pfizer initiating a randomised Phase III study (BRIGHT AML1019) investigating its sonic hedgehog pathway inhibitor drug glasdegib (PF-04449913) in combination with either intensive chemotherapy or azacitidine in patients with previously untreated AML.

Business Questions:

• What do KOLs see as the key benefits of targeting the WT1 antigen as a vaccine approach in AML?
• How conclusive are the Phase II results for GPS, according to KOLs?
• Do KOLs consider further development of GPS justified, and how risky do they see this approach to be?
• According to the experts, how valid is the approach of targeting E-selectin in AML?
• What elements of GMI-1271’s Phase II trial design are criticised by KOLs, and do these affect their opinion of the results?
• Could only modest efficacy gains be sufficient for the future success of GMI-1271?
• What settings will be most relevant for treatment with GMI-1271?
• Do KOLs see the OS improvement in the Phase II trial with glasdegib as significant?
• How does Pfizer’s choice of comparator to glasdegib affect KOLs’ opinion of the Phase II results?
• According to the KOLs, is glasdegib’s Phase III trial design well-designed and rigorous enough?
• What factors are most important to ensure the success of glasdegib?
• Which of the three drugs discussed do KOLs see as holding the most promise in AML?


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