Celgene’s CC-486 positioned to become standard maintenance therapy in acute myeloid leukemia

In Clinical Studies News by Barbara Jacoby

Source: Global Data

From: prnewswire.com

Celgene plans to pursue a new drug application (NDA) in Q1 2020 for its formulation of oral azacitidine (CC-486) after data from the Phase III QUAZAR AML-001 trial showed that maintenance therapy can prolong the overall survival (OS) of acure myeloid leukemia (AML) patients compared with placebo. As such, CC-486 is set to address a clear unmet need, says GlobalData, a leading data and analytics company.

Sakis Paliouras, PhD, GlobalData Oncology and Hematology Analyst, commented: “In AML, despite several trials in the maintenance setting, no agent has demonstrated a clinical benefit that is significant enough for widespread adoption, leaving the use of maintenance therapy at the physicians’ discretion. The closest competitor in this setting, decitabine, was associated with an OS benefit but showed no statistical significance.

“Upon regulatory confirmation, GlobalData expects CC-486 to become the new standard maintenance therapy for patients over 55 years old. Even though its use will be confined to one line of therapy, the lack of competition has the potential to result in widespread adoption by US-based hematologists, leading to significant revenue for Celgene.

“Furthermore, CC-486 can benefit from a first-mover advantage, as other agents undergoing trials in the same setting are not as advanced. A trial for the maintenance use of Genentech’s/AbbVie’s Venclexta (venetoclax), a potential competitor for CC-486 in this space, is expected to report results in Q3 2021, thus allowing CC-486 to monopolize this market for a significant period of time.”

Celgene, now a subsidiary of Bristol-Myers Squibb, has not had a branded chemotherapy option for AML since the patent expiry of its Vidaza (5-azacitidine) in 2011. Now, along with the recent approval and promising adoption of its IDH2 inhibitor Idhifa (enasidenib), which it co-owns with Agios, in a different AML patient population, Celgene is poised to become an important player in the AML market.