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ARIAD Gains on Updated Brigatinib Phase I/II Study Data

ARIAD Pharmaceuticals, Inc. ARIA announced positive updated data from an ongoing phase I/II study on its tyrosine kinase inhibitor, brigatinib, being conducted in patients with advanced malignancies including anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC).

The data included pharmacokinetics and safety analyses on all patients (n=137) in the study and efficacy analyses in patients (n=79) with ALK+ NSCLC. Data were presented at the European Lung Cancer Conference. The company’s shares jumped 4.6% on the news.

The updated data from the study showed a one-year overall survival rate of 100% in Pfizer Inc.’s PFE Xalkori (crizotinib)-naive patients and 81% in those patients who did not receive prior treatment with Xalkori. Of the 70 evaluable ALK+ NSCLC patients with prior Xalkori therapy when treated with brigatinib demonstrated median progression free survival (PFS) of 13.4 months while median PFS in the Xalkori-naive group has not been reached yet.

Nearly all of the evaluable ALK+ NSCLC patients showed tumor shrinkage with 25 patients experiencing 100% shrinkage of the target lesion. In addition, the new data showed expected pharmacokinetics with drug exposure increasing proportionally with dose.

We are encouraged by the study results. Apart from the ongoing phase I/II study, brigatinib is also being evaluated in a pivotal phase II ALTA study and the new phase III ALTA first-line study in the front-line setting. The company intends to file regulatory application in the U.S. for brigatinib later this year.

Currently, ARIAD has one sole marketed product in its portfolio, which is a leukemia drug, Iclusig. We expect investors focus to remain on updates pertaining to brigatinib development.

ARIAD is a Zacks Rank #2 (Buy) stock. A couple of favorably ranked stocks in the health care sector are Anika Therapeutics Inc. ANIK and Emergent BioSolutions, Inc. EBS, each sporting a Zacks Rank #1 (Strong Buy).

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