Ash 2019 – Quazar shines for Bristol

Full data from the phase III Quazar AML-001 trial of Bristol Myers-Squibb’s CC-486, an oral formulation of its chemotherapy azacitidine, look good, and set the asset up for approval in the competitive acute myelogenous leukaemia setting. Celgene said in September that the trial had hit, and today’s full results showed a highly significant 9.9 month median overall survival advantage for CC-486 over placebo. Safety was acceptable, with serious adverse events seen in 34% and 25% of patients in the CC-486 and placebo arms, respectively. CC-486 is thus teed up for approval as therapy to maintain patients’ response to induction chemotherapy. This is a subtly different setting to that of the leading product, Roche and Abbvie’s Venclexta, which is used first-line, on top of chemo, in older patients or those in whom induction chemotherapy cannot be used. Attention in the AML space will now flop back to Roche: the phase III Mirros trial of its MDM2 inhibitor idasanutlin will read out early next year.

Summary of Quazar AML-001 data
  CC-486  Placebo Placebo-adjusted benefit P value
Overall survival (months) 24.7 14.8 9.9 0.0009
Relapse-free survival (months) 10.2 4.8 5.3 0.0001
1-year relapse rate  53% 71%    
Serious adverse event rate 34% 25%    
Patients with ≥1 adverse event 98% 97%    
Source: Dr Andrew Wei, LBA-3, Ash 2019.
Source: Dr Andrew Wei, LBA-3, Ash 2019.

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