AbbVie (ABBV) Presents Impressive Imbruvica Data At ASH

AbbVie Inc. (NYSE:ABBV) and partner Janssen, Johnson & Johnson’s (NYSE:JNJ) pharmaceuticals subsidiary, presented encouraging results on their cancer drug Imbruvica at the annual meeting of the American Society of Hematology (ASH).

AbbVie’s share price has risen 3.3% in the past one month, comparing favorably with a decline of 1.3% for the Zacks classified Large-Cap Pharma industry.

Data from a phase II study (n=63) showed that nearly half of the patients with relapsed/refractory marginal zone lymphoma (MZL) had a complete or partial response when treated with the company’s hematological cancer drug Imbruvica. In the study, 79% of patients experienced some tumor reduction and overall response rates (ORR) was 48%. Safety data from the study was consistent with previous Imbruvica studies.

We remind investors that AbbVie submitted a supplemental New Drug Application (sNDA) for a label expansion of Imbruvica to include the treatment of MZL in September.

Imbruvica became part of AbbVie’s portfolio following the Pharmacyclics acquisition last March.

Imbruvica is presently approved for quite a few indications. The drug is currently approved in the U.S. for the treatment of mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) patients, who have received at least one previous therapy and for CLL patients with deletion 17p. It is also approved for the treatment of Waldenstrom's macroglobulinemia.

Imbruvica has multi-billion dollar potential and AbbVie is exploring the potential to expand its label into solid tumors and autoimmune diseases. Imbruvica is in phase III studies for diffuse large B-cell lymphoma and follicular lymphoma. AbbVie is positioning Imbruvica as a “pipeline in a molecule” with the treatment featuring in several company-sponsored studies. A registrational study for graft versus host disease (GVHD) is also underway.

In separate press releases, AbbVie announced five-year cancer-research collaborations with Johns Hopkins University School of Medicine and Northwestern University's Lurie Cancer Center.

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

AbbVie’s key drug Humira has been performing well. However, quite a few companies are working on bringing Humira biosimilars to the market. Amgen, Inc.’s (NASDAQ:AMGN) Humira biosimilar Amjevita received FDA approval in Sep 2016. Momenta Pharmaceuticals Inc.’s (NASDAQ:MNTA) biosimilar version of Humira, M923, is in a phase III study.

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