AbbVie (ABBV - Free Report) announced that a phase III study — VIALE-C — evaluating a combination regimen of its blood cancer drug, Venclexta (venetoclax), failed to meet primary endpoint. The study evaluated Venclexta in combination with low-dose cytarabine (“LDAC”) for improvement in overall survival (“OS”) in previously untreated patients with acute myeloid leukemia (“AML”) who are ineligible for intensive chemotherapy.
Data from the study showed that Venclexta plus LDAC failed to show statistically significant improvement in OS compared to LDAC plus placebo in AML patients.
The Venclexta combination regimen reduced risk of death by 25% versus LDAC with placebo. At the time of the primary analysis, median OS for Venclexta combo arm was 7.2 months versus 4.1 months for the comparator arm. An additional six months of follow up showed that treatment with Venclexta plus LDAC led to increase in median OS of 8.4 months and 4.1 months for LDAC plus placebo. Moreover, Venclexta combo also achieved complete remission in 27.3% patients compared to 7.4% for the LDAC plus placebo regimen.
Although Venclexta-LDAC combination regimen failed to show statistically significant improvement of OS, data indicated clinical activity in patients. The company has provided the study results to the FDA and other global health authorities.
AbbVie’s shares have increased 7.9% in the past year against the industry’s decrease of 2.2%.
Venclexta is approved in combination with chemotherapy — azacitidine, decitabine or LDAC — is approved under accelerated pathway for the treatment of newly-diagnosed AML. The drug 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 co-develops and co-commercializes Venclexta with Roche (RHHBY - Free Report) .
The VIALE-C study failure does not change the drug’s approved indications for now. AbbVie is evaluating Venxclexta in combination with azacitidine in another phase III study, VIALE-A, in patient population similar to VIALE-C study.
AbbVie has a strong AML research program with several clinical studies evaluating Venclexta and other pipeline candidates. The company is also 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. Venclexta along with another key cancer drug, Imbruvica, generated combined revenues of nearly $5.5 billion in 2019 and double-digit growth is expected in 2020. Please note that AbbVie co-develops and co-commercializes Imbruvica with J&J (JNJ - Free Report) .
AbbVie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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