AbbVie Presents Results from Phase I Study of Investigational Oncology Compound ABT-199 at American Society of Clinical Oncology

    AbbVie Presents Results from Phase I Study of Investigational Oncology
   Compound ABT-199 at American Society of Clinical Oncology Annual Meeting

Data in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia and
Non-Hodgkin's Lymphoma

Enrollment in Clinical Trials for ABT-199 Continues

PR Newswire

NORTH CHICAGO, Ill., June 3, 2013

NORTH CHICAGO, Ill., June 3, 2013 /PRNewswire/ --AbbVie (NYSE: ABBV) today
announced results from a Phase I study of ABT-199, an investigational BCL-2
(B-cell lymphoma 2) selective inhibitor, for the treatment of patients with
relapsed/refractory chronic lymphocytic leukemia (CLL), the most common
leukemia in the United States, and relapsed/refractory non-Hodgkin's lymphoma
(NHL). Results from the study were presented at the 2013 Annual Meeting of
the American Society of Clinical Oncology (ASCO).

This Phase I, open-label, multicenter, international trial was designed to
assess the safety, determine the maximum tolerated dose and recommended Phase
II dose, and evaluate the pharmacokinetics of ABT-199 in patients with
relapsed/refractory CLL and NHL. Secondary objectives included preliminary
efficacy, including objective response rate (ORR), duration of response, time
to progression, progression-free survival (PFS) and overall survival (OS).

"The ABT-199 data underscore AbbVie's commitment to the development of
treatments for some of the hardest-to-treat cancers like CLL and NHL," said
Gary Gordon, M.D., divisional vice president, oncology clinical development,
AbbVie. "Early trials of ABT-199 have shown the compound's potential in these
hematological malignancies, which support the continuation of its clinical
development program."

CLL Arm
As of April 2013, 56 patients have enrolled in the CLL arm of the Phase I
trial, and 40 patients are currently active. Study participants were given a
single oral dose of ABT-199, followed by six days without medication, before
continuous once-daily dosing. Due to concerns over tumor lysis syndrome (TLS),
the initial dose was reduced and daily dosing was modified. Single-agent
activity was observed in the trial and warrants further single-agent and
combination trials evaluating ABT-199 in patients with CLL. Dose and schedule
evaluation will continue.

"While still early in the development process, the activity with ABT-199 as a
single-agent supports further investigation of the compound in patients with
CLL, a patient population with a high unmet need for new treatment options,"
said Matthew Davids, M.D., attending physician in the Lymphoma Program of the
Division of Hematologic Malignancies at Dana-Farber Cancer Institute, and
Instructor in Medicine at Harvard Medical School.

During the study, 13 patients discontinued treatment; seven due to progression
of disease and six for other reasons (two due to TLS, two for other illnesses,
one for thromboembolic event and one consent withdrawal). The most common
non-hematological adverse events (AEs) during the study were nausea (36%),
diarrhea (30%), fatigue (25%), upper respiratory tract infection (23%) and
cough (16%). In the first study group, TLS occurred in all three of the
enrolled patients; once the modified dosing schedule was utilized, three of
the 53 patients experienced adverse events of TLS. One fatal adverse event
occurred in a patient with laboratory evidence of TLS.

Preliminary efficacy results showed that 46 of 55 patients (84%) achieved a
response to ABT-199. Specifically, ten patients (18%) achieved a complete
response (CR) or complete response with incomplete bone marrow recovery and 36
patients (65%) achieved a partial response (PR). The study also demonstrated a
response in patients with high-risk markers. A partial response was achieved
by 13 of 16 patients with deletion of the short arm of chromosome 17 (17p
deletion) and 14 of 18 patients with fludarabine-refractory CLL. Later stage
clinical trials are expected.

NHL Arm
As of April 2013, 32 patients have enrolled in the NHL arm of the trial, and
12 are currently active. Patients were given a single oral dose (50-400mg)
followed by six days without medication before being dosed with continuous
once-daily dosing. Due to concerns over TLS, a dose-escalation protocol was
implemented. Patients who were treated with up to 900mg have been evaluated to
date. Single-agent activity was observed in the trial and warrants further
clinical investigation. Dose escalation will continue to determine
maximum-tolerated dose and optimal dosing regimen.

The most common AEs (≥15% of patients) were nausea (36%), diarrhea (26%),
dyspepsia, vomiting, fatigue, pyrexia and cough (16% each). Grade 3/4 AEs
occurring in more than one patient were anemia, neutropenia (four patients
each), febrile neutropenia (two patients) and thrombocytopenia (three
patients). Grade 3/4 thrombocytopenia was not dose dependent. Grade 3 TLS was
seen after the initial dose in one patient with bulky MCL (>10 cm). With a
median follow-up of five months (range 0.5-15), 17 patients have discontinued:
13 due to progression of disease, two due to AEs and two proceeded to bone
marrow transplant (BMT) in ongoing response.

Preliminary efficacy results showed 17 of 32 patients (53%) achieved an
overall response rate (ORR), with one patient experiencing a complete response
and 15 patients experiencing a partial response. Studies are ongoing.

About ABT-199/GDC-0199
ABT-199 is a selective inhibitor of B-cell lymphoma-2 (BCL-2) proteins. The
B-cell lymphoma 2 gene prevents apoptosis of some cells including lymphocytes,
and can be highly expressed in cancers in the lymph nodes, spleen, and other
organs of the immune system. As a BH3-mimetic, ABT-199 is designed to block
the function of the BCL-2 protein by restoring the communication system that
tells cancer cells to self-destruct. Jointly developed by AbbVie and
Genentech, the companies are pioneering BCL-2 research with ABT-199, which is
currently in Phase 1/1b clinical trials for the treatment of CLL, the most
common leukemia in the United States, and several other cancers.

The U.S. Food and Drug Administration (FDA) recently accepted AbbVie's amended
clinical trial protocols for studies of ABT-199 in patients with CLL and
enrollment for ABT-199 clinical trials in CLL, NHL and multiple myeloma has
been re-instated. AbbVie and Genentech expect to move ABT-199 into later-stage
clinical trials in the near future.

About Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia (CLL) is the most common leukemia in the United
States, accounting for a third of the cases diagnosed each year. It is a
slow-progressing cancer of the blood and bone marrow in which the bone marrow
makes too many lymphocytes, a type of white blood cell that helps the body
fight infection. The cause of CLL is unknown, though researchers believe it
may be linked to a genetic mutation.

About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) includes a diverse group of blood cancers that
originates in lymphocytes, a type of white blood cell that are part of the
body's immune system. NHL is the most common hematological cancer, the fifth
leading cause of cancer death and the second fastest growing form of cancer in
the U.S. There are approximately 69,000 new cases of NHL diagnosed in the U.S.
per year and 19,000 deaths are attributed to the disease annually.

Mantle cell lymphoma (MCL) is an aggressive, rapidly progressive subtype of
NHL, and is not curable with standard treatment. The median life expectancy
for a patient with MCL following first relapse is one to two years.

About AbbVie Oncology
The fight against cancer is one of the greatest battles in medicine and the
varied nature of the disease requires a diverse approach that looks at
multiple disease targets in a variety of tumor types. AbbVie's oncology
research is focused on the discovery and development of targeted therapies
that work against the processes cancers need to survive. By investing in new
technologies and approaches, we are breaking ground in some of the most
widespread and difficult-to-treat cancers, including multiple myeloma and
chronic lymphocytic leukemia. Our oncology pipeline includes multiple new
molecules in clinical trials being studied in more than 15 different cancers
and tumor types.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013
following separation from Abbott.The company's mission is to use its
expertise, dedicated people and unique approach to innovation to develop and
market advanced therapies that address some of the world's most complex and
serious diseases.In 2013, AbbVie employs approximately 21,000 people
worldwide and markets medicines in more than 170 countries.For further
information on the company and its people, portfolio and commitments, please
visit www.abbvie.com.Follow @abbvie on Twitter or view careers on our
Facebookor LinkedIn page.

SOURCE AbbVie

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