Bristol Myers’ Idhifa Fails to Meet Goal in Leukemia Study

Bristol Myers Squibb BMY announced that the phase III IDHENTIFY study evaluating Idhifa in patients with relapsed or refractory acute myeloid leukemia (R/R AML) did not meet the primary endpointof overall survival. AML is one of the most difficult-to-treat blood cancers

Shares of the company have declined 2.3% year to date against the industry’s growth of 1.6%.

The IDHENTIFY study was evaluating the efficacy and safety of Idhifa plus best supportive care versus conventional care regimens in subjects 60 years or older with AML refractory to or relapsed after second- or third-line AML therapy with an IDH2 mutation. The conventional care regimens included continuous 28-day cycles of best supportive care (BSC) only —Vidaza (made by Bristol-Myers’ subsidiary Celgene) plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC. Results showed no statistically significant improvement in OS among patients in the Idhifa+BSC arm.

The company will present detailed results from the study at a future medical meeting.

We remind investors that Idhifa is approved by the FDA for the treatment of adult patients with relapsed or refractory AML with an IDH2 mutation as detected by an FDA-approved test. 

The company also markets anotherleukemia drug, Sprycel, contributing significantly to the top line. Sprycel is used in adults and children to treat a type of blood cancer called Philadelphia chromosome-positive chronic myelogenous leukemia (CML). The drug is also used to treat Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) in adults and children.

The company is looking to counter generic threat for its key drugs through deals and acquisitions, and by introducing new products to augment its product portfolio. Very recently, Bristol Myers announced a definitive agreement with privately-held, clinical-stage biopharmaceutical company, Forbius, for TGF-beta assets.

Zacks Rank and Stocks to Consider

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

Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS, Horizon Therapeutics Public Limited Company HZNP and Alimera Sciences Inc. ALIM. While Emergent and Horizon Therapeutics sport a Zacks Rank #1 (Strong Buy), Alimera carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have increased from $3.45 to $5.60 for 2020 and from $3.73 to $6.67 for 2021 over the past 60 days.

Horizon Therapeutics’ earnings estimates have increased from $1.77 to $2.86 for 2020 and from $2.72 to $4.29 for 2021 over the past 60 days.

Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days.

 

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