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AbbVie's Imbruvica Fails in Phase III Pancreatic Cancer Study

AbbVie Inc. ABBV announced that a combination regimen of its blockbuster cancer drug, Imbruvica (ibrutinib), failed in a phase III study, evaluating it for the treatment of metastatic pancreatic adenocarcinoma, one of the most aggressive and deadliest forms of cancer. The study was unable to meet its primary endpoint of improving progression-free survival (PFS) or overall survival (OS) benefit amid the given patient population.

The phase III RESOLVE study investigated the efficacy of Imbruvica in combination with chemotherapy agents nab-paclitaxel and gemcitabine compared with placebo in combination with these chemotherapy agents for first-line treatment of patients suffering metastatic pancreatic cancer. The study did not show a statistically-significant PFS or OS benefit in the Imbruvica combo arm as compared to the placebo one.

Complete data from the study will be submitted for presentation at a future medical conference.

Shares of AbbVie have declined 16% in the past year, wider than the industry’s dip of 0.8%.

 

Notably, Imbruvica has been jointly developed and marketed by AbbVie and Janssen Biotech, a unit of Johnson & Johnson JNJ.

Currently approved for nine cancer indications, Imbruvica has multi-billion-dollar potential and AbbVie is exploring the potential to expand Imbruvica’s label into solid tumors and autoimmune diseases.

In the first nine months of 2018, Imbruvica generated sales of $2.58 billion, reflecting a surge of 38.7% year over year. AbbVie expects Imbruvica’s peak sales to be more than $7 billion and revenues of about $5 billion in 2020. However, study failure like that of RESOLVE will cause a hindrance to AbbVie/J&J’s expansion plans for Imbruvica.

Another important cancer drug in AbbVie’s oncology portfolio is Venclexta. Regulatory applications seeking an approval for Venclexta plus Roche’s RHHBY Rituxan for relapse/refractory chronic lymphocytic leukemia (based on MURANO study data) were lent with a nod in the United States, last June and in the EU, last October. Visibly, label expansion for this indication has increased the patient population for Venclexta significantly, which will further boost its commercial potential.

Also, last November, AbbVie gained an FDA approval for Venclexta for first-line acute myeloid leukemia (AML) while outcomes from the phase III program on multiple myeloma are awaited in the first half of 2019. AbbVie/Roche also plans to soon file for approving Venclexta +Gazyva in first-line CLL setting.

Zacks Rank & Another Key Pick

AbbVie currently carries a Zacks Rank #2 (Buy). Another top-ranked stock in large cap pharma sector is H Lundbeck A/S HLUYY, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

H Lundbeck’s earnings estimates have moved 5.2% north for 2019 over the past 60 days.

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