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Novartis' (NVS) Leukemia Drug Meets Goal in Late-Stage Study

Novartis AG NVS announced positive data from a late-stage study, ASCEMBL, on pipeline candidate, asciminib, for the treatment of chronic myeloid leukemia.

Asciminib (ABL001) is an investigational treatment, specifically targeting the ABL myristoyl pocket (STAMP).  ASCEMBL is a phase III, multicenter, open-label, randomized study comparing asciminib with Pfizer’s PFE Bosulif in patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine-kinase inhibitors (TKIs).

The study met its primary endpoint of statistically significant superiority in major molecular response (MMR) rate at 24 weeks for asciminib as compared to bosutinib.

The results of the study will be shared with regulatory authorities. We remind investors that the FDA has granted Fast Track designation to asciminib.

Per the company, by specifically targeting the ABL myristoyl pocket, STAMP inhibition has the potential to help address resistance and intolerance in later treatment lines for CML.

The successful development of the candidate will strengthen Novartis’ oncology portfolio as it looks to fortify the core pharma business after having undertaken a series of restructuring measures and divesting its non-core businesses. Novartis’ Tasigna is already approved for CML.

The stock has lost 8.1% in the year so far against the industry’s growth of 2%.

 

Last month, Novartis’ second-quarter results were hit by the coronavirus pandemic as sales fell short of expectations. Nevertheless, Cosentyx maintains momentum for the company on recent label expansions, despite stiff competition from AbbVie’s ABBV Humira, and Taltz and Johnson & Johnson’s JNJ Tremfya. However, the FDA recently approved a label update for ophthalmology drug, Beovu, to include additional safety information regarding retinal vasculitis and retinal vascular occlusion. The growth trajectory that Beovu takes up following this label update is yet to be seen.

Novartis currently carries a Zacks Rank #3 (Hold).  You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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