AbbVie And J&J Present Positive Imbruvica Leukemia Data

AbbVie Inc. (NYSE:ABBV) recently announced positive data from a pooled analysis of three phase III studies evaluating its cancer drug, Imbruvica (ibrutinib). The drug is to be used for the treatment of patients with high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Imbruvica is currently approved in the U.S. for the treatment of patients with mantle cell lymphoma or CLL, who have received at least one therapy earlier and for CLL patients with deletion 17p. It is also approved for the treatment of Waldenstrom's macroglobulinemia. Please note that in Jan 2017, Imbruvica was approved for patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20 based therapy.

Analysis of the data from the three phase III studies (RESONATE, RESONATE-2 and HELIOS) showed that CLL/SLL patients with genomic abnormalities, when treated with Imbruvica, achieved higher complete response (CR) rates and overall response rates (ORR) as well as longer progression free survival (PFS) at 24 months and overall survival (OS) at 30 months versus patients treated with comparator-treated patients. CLL/SLL patients with genomic abnormalities are usually the ones who are at high risk for poor outcomes.

Data were presented at the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).

We note that Imbruvica became part of AbbVie’s portfolio following its acquisition of Pharmacyclics in May 2015. Imbruvica is jointly marketed by AbbVie and Janssen Biotech, a subsidiary of Johnson & Johnson (NYSE:JNJ) .

Shares of AbbVie have underperformed the Zacks classified Large Cap Pharma industry so far this year. The stock has gained 5.5% during the period, while the broader industry witnessed an increase of 8.6%.



AbbVie is presently exploring the potential to expand Imbruvica’s label into solid tumors (in phase III for diffuse large B-cell lymphoma and follicular lymphoma) and autoimmune diseases.

Notably, Imbruvica has one of the most robust clinical oncology development programs in the industry with nearly 30 company-sponsored trials underway. Of these, 14 are in phase III. The drug is approved for a number of indications and has multi-billion dollar potential. Moreover, another 100 investigator-sponsored trials and external collaborations for Imbruvica are underway around the world.

According to the company, more than 25,000 CLL patients have been treated in the U.S. alone with Imbruvica since approval in 2014. Per the company’s press release, nearly 19,000 patients are diagnosed with CLL every year in the U.S. Thus, there is a huge market potential for the drug to cater the unmet needs of patients in the nation.

Zacks Rank & Key Picks

AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Galena Biopharma, Inc. (NASDAQ:GALE) and VIVUS, Inc. (NASDAQ:VVUS) . While Galena carries a Zacks Rank #2 (Buy), VIVUS sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Galena’s loss per share estimates narrowed from $2.03 to 58 cents for 2017, over the last 60 days. The company posted positive earnings surprises in two of the four trailing quarters with an average beat of 53.83%.

VIVUS’s loss per share estimates narrowed from 50 cents to 39 cents for 2017, over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters with an average beat of 233.69%.

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