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Roche Announces Positive Data on Venclexta/Venclyxto at ASH


Roche Holding AG RHHBY announced new data from the phase III MURANO study on Venclexta/Venclyxto (venetoclax) in patients with previously treated chronic lymphocytic leukemia (CLL) at the American Society of Hematology (ASH) 2018 Annual Meeting.

Share price of the company has increased 6.2% year to date compared with the industry’s growth of 13.8%.

We remind investors that the FDA approved Venclexta in combination with Rituxan for second or later line CLL/small lymphocytic lymphoma (SLL) and in combination with a hypomethylating agent (azacitidine or decitabine) or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in elderly patients.

An analysis showed that the combination (Venclextaplus MabThera) reduced the risk of disease progression or death by 84% compared to standard of care in relapsed/refractory chronic lymphocytic leukemia (r/r CLL) —Teva Pharmaceutical’s TEVA Treanda (bendamustine) plus Rituxan (BR) after a median three-year follow-up. Follow up data from the study showed that the Venclexta combination achieved superior results as 71% of patients achieved progression free survival (“PFS”) at 36 months versus 15% of patients in the BR arm.

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.

A separate analysis showed higher rates of minimal residual disease (MRD)-negativity observed with Venclexta/Venclyxto plus MabThera/Rituxan compared to BR were sustained after patients completed treatment (62% versus 13%). These results were observed in majority of patients in the Venclexta/Venclyxto arm, including patients in high-risk subgroups and were consistent with the maintained PFS benefit seen with longer follow-up.

The company also announced updated data from two phase Ib/II (phase Ib M14-358 and phase I/II M14-387) studies in people with previously untreated acute myeloid leukaemia (AML) ineligible for intensive chemotherapy due to coexisting medical conditions. These results showed that among patients who were dependent upon blood transfusions at baseline, about half were able to achieve transfusion independence (the absence of transfusions during any consecutive 56 days during the study treatment period).

Based on earlier results from the M14-358 and M14-387 studies, the FDA granted accelerated approval to Venclexta in combination with a hypomethylating agent (azacitidine or decitabine), or low-dose cytarabine (LDAC), for the treatment of people with newly-diagnosed acute myeloid leukaemia (AML), who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions.

We remind investors that, Venclexta/Venclyxto is being developed by AbbVie ABBV and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the United States, and commercialized by AbbVie outside of the United States.

Zacks Rank & Stock to Consider

Roche is a Zacks Rank #3 (Hold) stock.

A better-ranked stock worth considering is Bristol-Myers Squibb Company BMY sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings per share estimates have increased from $3.63 to $3.87 for 2018 and $3.92 to $4.08 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 11.99%.

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