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AbbVie's Imbruvica Fails in Phase III Blood Cancer Study

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AbbVie ABBV announced that a combination regimen of its blockbuster cancer drug, Imbruvica (ibrutinib), failed in a phase III study – DBL3001 – evaluating it as first-line treatment for diffuse large B-cell lymphoma (“DLBCL”). The drug failed to improve event-free survival (“EFS”) compared to current standard of care.

DLBCL is an aggressive form of non-Hodgkin lymphoma (“NHL”), a type of blood cancer, for which no new therapy has been approved for over a decade for treatment-naive patients. The R-CHOP (combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy is the standard of care for these patients.

Shares of AbbVie slid 3.9% on Jul 11 following the news. The company’s shares have decreased 1.8% year to date compared with the industry’s decline of 2.5%.

The phase III study, which was conducted in collaboration with Johnson & Johnson JNJ, evaluated Imbruvica in combination with R-CHOP versus R-CHOP and placebo together. The primary endpoint of the study was superiority in EFS. The combination regimen was investigated for the treatment of DLBCL patients who have non-germinal center B cell (“GCB”) or activated B-cell (“ABC”) subtypes. Patients with these two subtypes commonly have poorer treatment outcomes with greater unmet medical need.

However, data from the study demonstrated improvement in a certain patient sub-population, which was clinically meaningful and may be analyzed further.

The company will present detailed analysis of the study at a future scientific conference and publish it in a peer-reviewed medical journal.

In a separate press release, AbbVie and its partner Roche RHHBY announced the submission of a supplemental New Drug Application (sNDA) for label expansion of leukemia drug, Venclexta (venetoclax). The sNDA is seeking approval of Venclexta in combination with a hypomethylating agent (“HMA”) or with low-dose cytarabine (“LDAC”) for treating newly diagnosed patients with acute myeloid leukemia (“AML”) who are ineligible for intensive chemotherapy.

The sNDA was filed based on data from two separate early stage studies evaluating Venclexta in combination with MHA and with LDAC.

Venclexta’s label was expanded last month as monotherapy or in combination with Roche/Biogen’s BIIB Rituxan for the treatment of relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma in second or later line settings.

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AbbVie currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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