AbbVie Inc. (ABBV - Free Report) presented encouraging long-term follow up data from two clinical studies evaluating Venclexta (venetoclax) combo therapy and Imbruvica (ibrutinib) monotherapy at the annual meeting of the American Society of Hematology (“ASH”).
The phase III MURANO study evaluated Venclexta in combination with Roche (RHHBY - Free Report) /Biogen’s (BIIB - Free Report) Rituxan (rituximab) compared to the current standard of care regimen, in relapsed/refractory chronic lymphocytic leukemia (r/r CLL) — Teva Pharmaceutical’s (TEVA - Free Report) Treanda (bendamustine) plus Rituxan. Follow up data from the study showed that the Venclexta combination achieved superior results as 71.4% patients achieved progression free survival (“PFS”) at 36 months versus 15.2% of patients in the standard of care. At 24 months, 84.9% and 36.3% patients achieved PFS for Venclexta combination and standard of care, respectively.
The patients were treated for a fixed duration of 24 months and treatment was stopped thereafter. The three-year estimated overall survival rate was 87.9% for Venclexta combination and 79.5% for standard of care.
Please note that regulatory applications seeking approval for including MURANO study data on Venclexta’s label were approved in the United States in June and in the EU in October. Label expansion for this indication has expanded the patient population for Venclexta significantly, which will boost its commercial potential.
Meanwhile, long-term follow-up data from the phase Ib/II study, which evaluated Imbruvica in CLL/small lymphocytic lymphoma (“SLL”) patients showed that the drug sustained PFS in 80% of previously untreated patients over seven years of treatment duration. It also showed that 32% of highly pre-treated patients whose disease had relapsed maintained PFS. The analysis of the data demonstrated Imbruvica achieved better PFS rates in r/r patients when treated in earlier line settings, especially after one or two prior lines of therapy.
The long-term efficacy data for Imbruvica in CLL/SLL patients may boost the adoption of the drug, thereby, driving its sales higher.
AbbVie’s shares have lost 2.5% this year so far against the industry’s rally of 11.3%.
We remind investors that Venclexta is approved in combination with Rituxan for second or later line CLL/SLL and in combination with a hypomethylating agent (azacitidine or decitabine) or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in elderly patients.
Imbruvica is approved for several indications, which include mantle cell lymphoma, CLL/SLL, Waldenström’s macroglobulinemia, marginal zone lymphoma and chronic graft versus host disease.
While Imbruvica is a blockbuster drug, having recorded $2.9 billion in the first nine months of 2018, Venclexta generated $220 million in the same period. Both the drugs have shown strong growth this year on the back of label expansions in broader patient population. The company is committed to expand the label of the drugs further, evaluating them in several clinical studies.
AbbVie currently has 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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