Data Support Venclexta Combinations As New Treatment Option for AML Interview with:

Nancy Valente, M.D.,
Vice President, Global Hematology Development
Genentech  What is the background for this study?  What are the main findings?

Response: Acute myeloid leukemia, or AML, is a particularly aggressive blood cancer with the lowest survival rate for all types of leukemia.

Many people with this disease are unable to tolerate intensive induction chemotherapy, so additional treatment options are needed and welcomed in this patient population.

At ASH, we presented updated data from two Phase Ib/II studies with longer follow up for Venclexta combinations. These data supported the recent accelerated approval of Venclexta by the FDA for people newly-diagnosed with AML who are unable to tolerate aggressive therapies.

These updated results showed that Venclexta demonstrated complete remission rates (with at least partial blood count recovery, CR+CRh) of 67 percent and 71percent when used in combination with azacitidine or decitabine, respectively ,and 54 percent when used in combination with low-dose cytarabine (LDAC). These responses were durable with a median duration of response of 16 months for patients treated with Venclexta plus azacitadine and 8 months for those treated with Venclexta plus LDAC.

AML is a difficult-to-treat disease and these Venclexta combinations represent an important new treatment option for patients. Venclexta has been granted four breakthrough therapy designations by the FDA, two in AML and two in chronic lymphocytic leukemia (CLL). What should readers take away from your report?

Response: These results further support Venclexta combinations as a new treatment option for people with AML. Venclexta is the first and only FDA-approved medicine designed to selectively bind and inhibit the BCL-2 protein, which helps trigger a natural process that helps cells self-destruct. It represents a new way to help people who have not received treatment for this aggressive type of blood cancer and are unable to tolerate intensive induction chemotherapy. What recommendations do you have for future research as a result of this work?

Response: A robust clinical development program for Venclexta in AML is ongoing, including two ongoing Phase III studies (Viale-A,Viale-C) evaluating Venclexta in combination with azacitidine or with LDAC for people with previously untreated AML who are ineligible for intensive chemotherapy. This is part of a larger development program for Venclexta in multiple blood cancers including CLL, multiple myeloma and non-Hodgkin’s lymphoma (NHL).The benefit of Venclexta has already been demonstrated in adults with previously treated CLL, with or without 17p deletion, with its approval in the U.S. and EU.


Venetoclaxin Combination with Hypomethylating Agents Induces Rapid, Deep, and DurableResponses in Patients with AML Ineligible for Intensive Therapy

ASH 2018 Sunday, December 2, 2018: 8:00 AM

Dec 11, 2018 @ 10:46 pm

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