AbbVie (ABBV - Free Report) announced positive interim analysis data from a phase III study —VIALE-A —evaluating a combination regimen of its blood cancer drug, Venclexta (venetoclax) in previously-untreated acute myeloid leukemia (“AML”) patients, who are ineligible for intensive chemotherapy.
The VIALE-A study evaluated Venclexta in combination with azacitidine (Vidaza), versus placebo in combination with azacitidine. Data from the first interim analysis of the study, showed that Venclexta combo met the study’s co-primary endpoints of statistically significant improvement of overall survival (OS) and composite complete remission rate (CR + CRi), compared to placebo arm.
An independent data monitoring committee recommended early report of the study data and submission to regulatory authorities based on positive efficacy results. Detailed data from the study will be presented at a future medical meeting or published in a peer-reviewed journal.
AbbVie’s shares have declined 27.2% so far this year compared with the industry’s decrease of 21%
Please note that AbbVie co-develops and co-commercializes Venclexta with Roche (RHHBY - Free Report) .
Venclexta is approved in combination with chemotherapy — azacitidine, decitabine or LDAC —under accelerated pathway for the treatment of newly-diagnosed AML. AbbVie and Roche were conducting two phase III studies — VIALE-A and VIALE-C — as confirmatory studies to convert the accelerated approval into continued approval.
In February, the companies announced that VIALE-C failed to meet its primary endpoint. The study evaluated Venclexta in combination with low-dose cytarabine (“LDAC”) for improvement in OS. Although the Venclexta-LDAC combination regimen failed to show statistically significant improvement of OS, data indicated clinical activity in patients.
Venclexta is also approved as monotherapy and in combination with Roche’s Gazyva or Roche/Biogen’s (BIIB - Free Report) Rituxan for treating chronic lymphocytic leukemia or small lymphocytic lymphoma.
AbbVie is strengthening its oncology portfolio through label expansions of marketed drugs as well as new drug development. It believes that oncology will be its major growth driver over the next 10 years. Apart from Venclexta, another key cancer drug in AbbVie’s portfolio includes Imbruvica, which it co-develops and co-commercializes Imbruvica with J&J (JNJ - Free Report) .
AbbVie currently holds 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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