Genentech Submits Supplemental New Drug Application to FDA for Venclexta Plus Gazyva for Previously Untreated Chronic Lymphocytic Leukemia with Co-Existing Medical Conditions

– Application is being reviewed under FDA’s Real-Time Oncology Review pilot program –

– Combination was granted Breakthrough Therapy Designation, the fifth for Venclexta –

SOUTH SAN FRANCISCO, CA, USA I March 7, 2019 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. The FDA is reviewing the application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

“More than 20,000 people will be diagnosed with untreated chronic lymphocytic leukemia in the United States this year, and many are ineligible for intensive chemotherapy-based options,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are encouraged that this chemotherapy-free, fixed-duration combination is being reviewed under the FDA’s Real-Time Oncology Review pilot program, and we are working closely with the agency to bring this new option to people with previously untreated chronic lymphocytic leukemia as quickly as possible.”

Breakthrough Therapy Designation was granted based on results of the randomized Phase III CLL14 study, evaluating the fixed-duration combination of Venclexta plus Gazyva, compared to Gazyva plus chlorambucil, in people with previously untreated CLL and co-existing medical conditions. The study met its primary endpoint and showed a statistically significant reduction in the risk of disease worsening or death (progression-free survival [PFS] as assessed by investigator) compared to standard-of-care Gazyva plus chlorambucil. Safety for the Venclexta plus Gazyva combination appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Data from the CLL14 study will be presented at an upcoming medical meeting. The CLL14 study is being conducted in cooperation with the German CLL Study Group (GCLLSG), headed by Michael Hallek, M.D., University of Cologne.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.

About the CLL14 Study

CLL14 (NCT02242942) is a randomized Phase III study evaluating the combination of fixed-duration Venclexta plus Gazyva compared to Gazyva plus chlorambucil in patients with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. 432 patients with previously untreated CLL were randomly assigned to receive either a 12-month duration of Venclexta alongside six-month duration of Gazyva (Arm A) or six-month duration of Gazyva plus chlorambucil followed by an additional six-month duration of chlorambucil (Arm B). The primary endpoint of the study is investigator-assessed progression-free survival (PFS). Secondary endpoints include PFS assessed by independent review committee (IRC), minimal residual disease (MRD) status, overall response (OR), complete response (with or without complete blood count recovery, CR/CRi), overall survival (OS), duration of response, event-free survival, time to next CLL treatment and safety. The CLL14 study is being conducted in cooperation with the German CLL Study Group (GCLLSG), headed by Michael Hallek, M.D., University of Cologne.

About CLL

Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia. In the United States, it is estimated that more than 20,000 new cases of CLL will be diagnosed in 2019. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of cancerous cells.

About Venclexta

Venclexta is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to restore the process of apoptosis.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood and other cancers.

In the United States, Venclexta has been granted five Breakthrough Therapy Designations by the U.S. Food and Drug Administration (FDA): in combination with Gazyva for people with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions; in combination with Rituxan for people with relapsed or refractory CLL; as a monotherapy for people with relapsed or refractory CLL with 17p deletion; in combination with hypomethylating agents (azacitidine or decitabine) for people with untreated acute myeloid leukemia (AML) ineligible for intensive chemotherapy; and in combination with low-dose cytarabine for people with untreated AML ineligible for intensive chemotherapy.

About Gazyva

Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system. Gazyva was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the United States, Gazyva is part of a collaboration between Genentech and Biogen.

Combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.

Venclexta Indications

Venclexta is a prescription medicine used:

  • To treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least 1 prior treatment.
  • In combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
    ‒ Are 75 years of age or older, or
    ‒ Have other medical conditions that prevent the use of standard chemotherapy.

Gazyva Indications

Gazyva® (obinutuzumab) is a prescription medicine used:

  • With the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.
  • With the chemotherapy drug, bendamustine, followed by Gazyva alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.
  • With chemotherapy, followed by Gazyva alone in those who responded, to treat stage II bulky, III, or IV FL in adults who have not had previous FL treatment.

About the German CLL Study Group (GCLLSG)

Founded in 1996 and headed by Michael Hallek, M.D., the GCLLSG has been running various Phase III, Phase II and Phase I trials in chronic lymphocytic leukemia (CLL) with the goal to provide optimal treatment to patients suffering from this disease. Among those were landmark trials like the CLL8 and the CLL11 trials which led to the current standard of care in CLL. For many years, GCLLSG has been aiming to improve not just the treatment of younger and physically fit patients, but also that of elderly and less fit patients. These patients are generally underrepresented in clinical trials although they constitute the majority of CLL patients treated by doctors in daily practice. The GCLLSG is an independent non-profit research organization supported by the German Cancer Aid (Deutsche Krebshilfe). http://www.dcllsg.de.

About Genentech in Hematology

For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

SOURCE: Genentech

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