—74% (14/19) ORR and 68% (13/19) CR rate at 3
months and 50% (7/14) CR at 6 months in core group at dose level
2—
—Across doses, 80% (16/20) of core group
patients in CR at month 3 remain in response at month 6; 92%
(11/12) of core group patients in response at 6 months remain in
response as of data cutoff—
—1% (1/67) severe CRS and 15% (10/67) severe NT
in core group: safety profiles appear similar between full and core
groups—
—Data continue to support better responses at
dose level 2 without dose related toxicity observed for CRS and NT,
compared to dose level 1 in core group—
Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical
company developing innovative cellular immunotherapies for the
treatment of cancer, and Celgene Corporation (NASDAQ: CELG) today
released additional data from the TRANSCEND study of JCAR017
(lisocabtagene maraleucel; liso-cel) in patients with relapsed or
refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (NHL) in a
presentation at the 59th American Society of Hematology (ASH)
Annual Meeting and Exposition.
This press release features multimedia. View
the full release here:
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“We are highly encouraged by the latest efficacy and
tolerability data, particularly at dose level two, as these are
patients with a poor prognosis who need better treatment options,”
said Sunil Agarwal, M.D., Juno’s President of Research and
Development. “These data support a potential best-in-class profile
and further support the importance of a defined cell product. We
continue to enroll our pivotal cohort in DLBCL patients and over
the next twelve to eighteen months we intend to explore earlier
lines of therapy, additional therapeutic areas, and
combinations.”
TRANSCEND is an open-label, multicenter Phase 1 study to
determine the safety, pharmacokinetics, and antitumor activity of
JCAR017 in adult patients with relapsed or refractory diffuse large
B cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma,
follicular lymphoma Grade 3B, and mantle cell lymphoma.
The data were based on a cutoff date of October 9, 2017 and
presented by Jeremy Abramson, M.D., of Massachusetts General
Hospital, who is a Principal Investigator for the TRANSCEND study.
They add to those disclosed on November 1, 2017 in ASH Abstract
#581.
As with previous readouts, the TRANSCEND data were presented for
both the core and full groups. The core group (N=67) includes 29
patients who received dose level two (DL2 = 100 million cells), 34
patients who received dose level one (DL1 = 50 million cells), and
4 patients who received dose level one twice, approximately 14 days
apart.
The core group includes patients with DLBCL (NOS and transformed
from follicular lymphoma) who are ECOG Performance Status 0-1.
These patients represent a high-risk patient population, with
approximately 90% of treated patients having one or more predictors
of poor survival, including double or triple hit lymphoma, being
chemorefractory to front-line or subsequent therapies, never
reaching a complete remission with prior treatments, or never
having undergone an autologous transplant. Enrollment of the
pivotal cohort is ongoing with the core group at DL2.
The full analysis group represents evaluable r/r patients in the
DLBCL cohort (N=91), which includes an additional 24 patients
with poor performance status (ECOG Performance Status 2) or with
niche subtypes of aggressive NHL. In both analysis groups all
efficacy data are based on at least one month of follow-up with a
28-day restaging scan and all safety evaluable data are based on
having received JCAR017 (liso-cel) with at least one month of
follow-up. Product was available for 98% (126/128) of patients
apheresed in the DLBCL cohort.
“The results of this study continue to show the exciting
potential of this CAR T therapy,” said Jay Backstrom, Chief Medical
Officer and Global Head of Regulatory Affairs for Celgene. “Our
collaboration with Juno reflects our commitment to delivering
transformational treatments to patients with blood cancers such as
non-Hodgkin lymphoma.”
Topline data from the presentation as of the October 9, 2017
data cutoff date included:
Responses in core group
- At DL2, the data showed a 3 month
overall response rate (ORR) of 74% (14/19) and a 3 month complete
response (CR) rate of 68% (13/19). Of patients that have reached 6
months of follow-up, 50% (7/14) were in CR. Across doses, 80%
(16/20) of patients with CR at 3 months stayed in CR at 6 months,
and 92% (11/12) of patients in response at 6 months remain in
response as of data cutoff.
- Across doses, median duration of
response (DOR) was 9.2 months and median durability of CR was not
reached.
Tolerability in core group
- 1% (1/67) experienced severe cytokine
release syndrome and 15% (10/67) experienced severe
neurotoxicity.
- 36% (24/67) had any grade CRS and 21%
(14/67) had any grade NT.
- 58% (39/67) had no CRS or NT of any
grade.
- At dose level 1, 3% (1/34) experienced
severe CRS and 21% (7/34) experienced severe NT.
- At dose level 2, 0% (0/29) experienced
severe CRS and 7% (2/29) experienced severe NT.
- 13% (9/67) received tocilizumab and 18%
(12/67) received corticosteroids.
Tolerability across doses in full group
- 1% (1/91) experienced severe CRS and
12% (11/91) experienced severe NT.
- 35% (32/91) had any grade CRS and 19%
(17/91) had any grade NT.
- 60% (55/91) had no CRS or NT of any
grade.
- The most common treatment-emergent
adverse events (TEAEs) other than CRS and NT that occurred at ≥25%
included neutropenia (49%), anemia (38%), fatigue (37%),
thrombocytopenia (29%), nausea (27%), and diarrhea (25%). The most
common TEAEs were similar between core and full groups.
JCAR017 (liso-cel) is a defined composition CD19-directed CAR T
cell product candidate using a 4-1BB costimulatory domain. Juno
believes JCAR017’s clinical profile could enable outpatient
administration. A biologics license application filing is expected
to be completed in the second half of 2018, with approval as early
as the end of 2018.
ASH Investor and Analyst Event and Webcast
The Juno ASH Investor and Analyst Event and webcast will be held
Monday, December 11, 2017 at 8:30 p.m. Eastern 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 developing innovative cellular
immunotherapies for 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 multiple solid tumors and
multiple myeloma. 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 (SCRI), 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. Juno’s product
candidate JCAR017 was developed in collaboration with SCRI and
others. JCAR017 is an investigational CAR T therapy and is not
approved for use in any country.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow Celgene
on Social Media: @Celgene, Pinterest, LinkedIn, FaceBook and
YouTube.
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, which
are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," “outlook” and similar expressions. Forward-looking
statements are based on management’s current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. Celgene and Juno undertake no obligation to update
any forward-looking statement in light of new information or future
events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which
are difficult to predict and are generally beyond the control of
either company. Actual results or outcomes may differ materially
from those implied by the forward-looking statements as a result of
the impact of a number of factors, many of which are discussed in
more detail in the public reports of each company filed with
the Securities and Exchange Commission.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171211005346/en/
Juno Therapeutics, Inc.Investor Relations:Nicole Keith,
206-566-5521nikki.keith@junotherapeutics.comorMedia:Christopher Williams,
206-566-5660chris.williams@junotherapeutics.comorCelgene
CorporationInvestor Relations:Patrick Flanigan,
908-673-9969pflanigan@celgene.comorMedia:Greg Geissman,
908-673-9854ggeissman@celgene.com
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