Juno Therapeutics Announces Complete Response & Corresponding Early Survival Data for JCAR014 in Patients with Ibrutinib-Refr...
December 03 2016 - 10:45AM
Business Wire
-- 88% complete marrow response by flow
cytometry in efficacy-evaluable patients
--100% progression-free and overall survival in
patients with undetectable disease in bone marrow
-- Study data support the development of
JCAR017 in CLL
Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical
company developing innovative cellular immunotherapies for the
treatment of cancer, today announced in a presentation at the 58th
American Society of Hematology (ASH) Annual Meeting encouraging
early data for JCAR014 in patients with chronic lymphocytic
leukemia (CLL) who failed treatment with ibrutinib. Insights from
studies of the translational product, JCAR014, are being applied to
the development of JCAR017 for the treatment of B-cell
malignancies. Both JCAR014 and JCAR017 use a 4-1BB co-stimulatory
domain and defined 1:1 cell ratio of CD4:CD8 T cells.
“The responses and durability we’ve seen in this study are
notable and demonstrate the potential for further investigation of
JCAR017 for patients with relapsed/refractory high-risk CLL,” said
Mark J. Gilbert, M.D., Juno’s Chief Medical Officer. “This is
especially important, given recent data that show these patients,
who progress early on ibrutinib, have poor clinical outcomes with a
median survival of approximately three months. In addition,
emerging response criteria, such as undetectable disease in the
bone marrow at the molecular level by deep sequencing, appear to
correlate with long-term response duration.”
The Phase I study (ASH Abstract #56), conducted by Cameron
Turtle, MBBS, Ph.D., of the Fred Hutchinson Cancer Research Center,
evaluated 24 heavily pre-treated patients, all of whom had failed
ibrutinib, the standard-of-care treatment for CLL. Patients had
received a median of five previous therapies, including three who
failed prior allogeneic stem cell transplants. Patients received
lymphodepletion with either fludarabine/cyclophosphamide (flu/cy)
(N=21) or non-flu/cy (N=3) prior to infusion of JCAR014.
Key data for the flu/cy cohort include:
- Two of 24 (8%) patients developed grade
3-5 severe cytokine release syndrome (sCRS) and 6/24 (25%) patients
developed grade 3-5 severe neurotoxicity. The most frequent
severe Treatment Emergent Adverse Events were febrile neutropenia
(75%), CRS (29%), fever (17%), lung infection (13%), encephalopathy
(13%), and hypotension (13%). There was one treatment-related
mortality (4%) in the trial in a patient who received
flu/cy lymphodepletion, with both grade 5 CRS and cerebral
edema.
- Of 17 efficacy-evaluable patients with
bone marrow disease at the start of the trial and treated with
flu/cy and the two lowest doses of JCAR014, 15/17 (88%) had a
complete marrow response by flow cytometry. Fourteen of the
complete bone marrow response patients had a response assessment by
the more sensitive method of IgH deep sequencing, with 7/14 (50%)
having no detectable disease. All seven of these patients are alive
and progression free with follow-up ranging from 3 to 26 months.
The complete marrow response by flow cytometry was similar in
patients documented to be ibrutinib-refractory at 86% (12/14).
- In patients with PET-avid disease at
baseline and treated with flu/cy and the two lowest doses of
JCAR014, 8/11 (73%) had a partial response (PR) or complete
response (CR) at four weeks, with 7/11 (64%) having a CR.
- In patients evaluated for efficacy at
four weeks using IWCLL criteria and treated with flu/cy and the two
lowest doses of JCAR014, 14/19 (74%) had a PR or CR, with 4/19
(21%) being a CR. All patients with either a CR or PR remain alive,
with follow-up ranging from 3 to 26 months. There is no obvious
early difference in time to progression between a CR and PR by
IWCLL criteria. The response data were similar in patients
documented to be ibrutinib-refractory, with overall response rate
of 69% (11/16) and a CR rate of 25% (4/16).
Plans to study JCAR014 in combination with ibrutinib in CLL are
underway, with a cohort expected to begin enrollment in early 2017.
Juno is evaluating the use of this data with JCAR014 as a
monotherapy and in combination with ibrutinib in support of a
potential Juno-sponsored trial with JCAR017 in CLL.
ASH Investor and Analyst Event and Webcast
The Juno ASH Investor and Analyst Event and webcast will be held
Monday, December 5, 2016 at 8:30 p.m. Pacific Time. The webcast can
be accessed live on the Investor Relations page of Juno's website,
www.JunoTherapeutics.com, and will be available for replay for 30
days following the event.
ABOUT JUNO
Juno Therapeutics is building a fully integrated
biopharmaceutical company focused on re-engaging the body’s immune
system to revolutionize the treatment of cancer. Founded on the
vision that the use of human cells as therapeutic entities will
drive one of the next important phases in medicine, Juno is
developing cell-based cancer immunotherapies based on chimeric
antigen receptor and high-affinity T cell receptor technologies to
genetically engineer T cells to recognize and kill cancer. Juno is
developing multiple cell-based product candidates to treat a
variety of B-cell malignancies as well as solid tumors. Several
product candidates have shown compelling clinical responses in
clinical trials in refractory leukemia and lymphoma conducted to
date. Juno's long-term aim is to leverage its cell-based platform
to develop new product candidates that address a broader range of
cancers and human diseases. Juno brings together innovative
technologies from some of the world's leading research
institutions, including the Fred Hutchinson Cancer Research
Center, Memorial Sloan Kettering Cancer Center, Seattle
Children's Research Institute, the University of California,
San Francisco, and The National Cancer Institute. Juno
Therapeutics has an exclusive license to the St. Jude
Children’s Research Hospital patented technology for
CD19-directed product candidates that use 4-1BB, which was
developed by Dario Campana, Chihaya Imai, and St. Jude
Children’s Research Hospital.
ABOUT THE JUNO-CELGENE COLLABORATION
Celgene Corporation and Juno Therapeutics formed a collaboration
in June 2015 under which the two companies will leverage T cell
therapeutic strategies to develop treatments for patients with
cancer and autoimmune diseases with an initial focus on chimeric
antigen receptor (CAR) and T cell receptor (TCR) technologies. In
April 2016, Celgene exercised its option to develop and
commercialize the Juno CD19 program outside North America and
China.
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, Section 27A of the Securities Act of 1933, and Section 21E of
the Securities Exchange Act of 1934, including statements regarding
Juno’s mission, progress, and business plans, clinical trial
results and the implications thereof, the potential of JCAR017 to
treat patients with CLL, clinical trial plans and timing, and the
potential of the collaboration between Juno and Celgene.
Forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially from such
forward-looking statements, and reported results should not be
considered as an indication of future performance. These risks and
uncertainties include, but are not limited to, risks associated
with: the success, cost, and timing of Juno's product development
activities and clinical trials; Juno's ability to obtain regulatory
approval for and to commercialize its product candidates; Juno's
ability to establish a commercially-viable manufacturing process
and manufacturing infrastructure; regulatory requirements and
regulatory developments; success of Juno's competitors with respect
to competing treatments and technologies; Juno's dependence on
third-party collaborators and other contractors in Juno's research
and development activities, including for the conduct of clinical
trials and the manufacture of Juno's product candidates; Juno's
dependence on Celgene for the development and
commercialization outside of North
America and China of Juno’s CD19 product candidates
and any other product candidates for
which Celgene exercises an option; Juno’s dependence
on JW Therapeutics (Shanghai) Co., Ltd, over which Juno does
not exercise complete control, for the development and
commercialization of product candidates in China; Juno's
ability to obtain, maintain, or protect intellectual property
rights related to its product candidates; amongst others. For a
further description of the risks and uncertainties that could cause
actual results to differ from those expressed in these
forward-looking statements, as well as risks relating to Juno's
business in general, see Juno's Quarterly Report on Form 10-Q filed
with the Securities and Exchange
Commission on November 9, 2016 and Juno’s other
periodic reports filed with the Securities and Exchange
Commission. These forward-looking statements speak only as of the
date hereof. Juno disclaims any obligation to update these
forward-looking statements.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161203005025/en/
Juno Therapeutics, Inc.Investor Relations:Nicole Keith,
206-566-5521nikki.keith@junotherapeutics.comorMedia:Christopher
Williams, 206-566-5660chris.williams@junotherapeutics.com
JUNO THERAPEUTICS, INC. (NASDAQ:JUNO)
Historical Stock Chart
From Mar 2024 to Apr 2024
JUNO THERAPEUTICS, INC. (NASDAQ:JUNO)
Historical Stock Chart
From Apr 2023 to Apr 2024