Celgene's (CELG) Leukemia Candidate Meets Endpoints In Study

Celgene Corporation (NASDAQ:CELG) announced top-line results from the international phase III study, QUAZAR AML-001. The study evaluated the efficacy and safety of investigational CC-486 (oral azacitidine)as maintenance therapy in patients with newly-diagnosed acute myeloid leukemia (AML), who achieved first complete response (CR) or complete response with incomplete blood count recovery (CRi) with induction chemotherapy.

The primary endpoint of the study was overall survival. The study results showed that maintenance treatment with CC-486 resulted in a highly statistically significant and clinically meaningful improvement in overall survival compared to placebo. The key secondary endpoint of relapse-free survival (RFS) also showed a statistically significant improvement.

Shares of the company have surged 54.2% year to date against the industry’s decline of 1.3%.

CC-486 was well tolerated and there were no unexpected safety events in the QUAZAR AML-001 study. This is the first phase III study to show that the addition of maintenance therapy has the potential to extend OS in a broad population of patients with newly-diagnosed AML, who have achieved remission with induction chemotherapy.

We note that, AML is a type of cancer in which the bone marrow makes abnormal blast cells that are supposed to grow into different types of blood cells. AML progresses rapidly and is typically fatal within weeks or months if left untreated.

Last month, the FDA approved Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. Myelofibrosis is a serious and rare bone marrow disorder that disrupts the body’s normal production of blood cells.

Celgene has been in the news since January 2019 due to a merger announcement with large-cap pharma Bristol-Myers Squibb Co. (NYSE:BMY) for a whopping $74 billion.

Zacks Rank & A Stock to Consider

Currently, Celgene is a Zacks Rank #3 (Hold) stock.

Some better-ranked stocks in the biotech sector are Amgen Inc. (NASDAQ:AMGN) and Acorda Therapeutics Inc. (NASDAQ:ACOR) . Both these stocks sport Zacks Rank #1 (Strong Buy), at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Amgen’s earnings per share estimates have increased from $13.92 to $14.30 for 2019, and from $14.76 to $15.42 for 2020, in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, the average beat being 6.72%.

Acorda’s loss per share estimates for the current year narrowed from $4.11 to $2.97 for 2019 and from $3.26 to $3.11 for 2020 over the past 60 days. The company recorded a positive earnings surprise in the preceding four quarters, the average beat being 155.36%.

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