AbbVie (ABBV) and Roche’s (RHHBY) Genentech have revealed positive results from the Phase III VIALE-A study, evaluating Venclexta (venetoclax) with azacitidine in people with previously untreated acute myeloid leukemia (AML) who were ineligible for intensive induction chemotherapy.
The results were featured in the 25th European Hematology Association Virtual Congress Press Briefing on June 13.
“The significant survival benefits observed in the VIALE-A study reinforce the potential utility of this Venclexta-based combination for people with this aggressive disease” commented Levi Garraway, CMO at Genentech.
Indeed, AML is the most common type of aggressive leukemia in adults, which has the lowest survival rate for all types of leukemia. In 2020, it is estimated there will be nearly 20,000 new cases of AML diagnosed in the US, with many older AML patients unable to tolerate intensive induction chemotherapy treatment.
Results from the VIALE-A study showed that the Venclexta combination reduced the risk of death (overall survival [OS]) by 34% compared to azacitidine alone (median OS=14.7 months vs. 9.6 months; HR: 0.66, 95% CI: 0.52–0.85, p<0.001) in people with previously untreated AML.
The Venclexta plus azacitidine combination also led to higher rates of composite complete remission (CR + CR with incomplete blood count recovery [CR + CRi]) at 66.4% compared to 28.3% with azacitidine alone (p<0.001).
Safety for Venclexta plus azacitidine appeared consistent with the known safety profile of these medicines and no unexpected safety signals were identified with the combination.
The study also met its secondary endpoint of CR and CR with partial hematologic recovery (CR + CRh), with the combination showing a CR + CRh of 64.7% compared to 22.8% with azacitidine alone.
Venclexta has previously been granted accelerated approval by the FDA in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of people with newly diagnosed AML aged 75 years or older, or for those ineligible for intensive induction chemotherapy.
The 433-person VIALE-A study is part of Venclexta’s ongoing development program to convert the current accelerated approval to a full approval. Venclexta has also been granted five Breakthrough Therapy Designations by the FDA, including two for previously untreated AML.
Venclexta is jointly commercialized by both AbbVie and Roche in the United States and by AbbVie outside of the United States. It is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein.
Shares in ABBV are currently trading up 4% year-to-date, and analysts have a bullish Strong Buy outlook on the stock with 11 recent buy ratings vs 2 hold ratings. The average analyst price target of $105 translates into 14% upside potential from current levels. (See ABBV stock analysis on TipRanks)
On June 10 RBC Capital’s Randall Stanicky reiterated his AbbVie buy rating and $102 price target following news of the Genmab (GMAB) collaboration to jointly develop and commercialize three of GMAB’s early-stage investigational bispecific antibody product candidates.
“While a balance sheet friendly add to hematology /oncology, the growth story forming on the other side of HUMIRA is under-appreciated and has potential to drive valuation re-rating” he commented.
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