Celgene Corp. Announces Initial Clinical Data from Ongoing Phase 1/2 Evolve Trial with Anti-BCMA CAR T Therapy JCARH125 in Re...
December 03 2018 - 7:30PM
Business Wire
82% overall response rate observed in heavily
pre-treated patients
9% of patients experienced grade 3/4 cytokine
release syndrome; 7% experienced a grade 3/4 neurological event
Celgene Corporation (NASDAQ:CELG) today announced initial safety
data from its ongoing proof-of-concept trial of JCARH125 in
patients with relapsed/refractory multiple myeloma. JCARH125 is an
investigational BCMA-targeting CAR T cell therapy being developed
by Juno Therapeutics, A Celgene Company. Results were
presented by Sham Mailankody, MBBS, in an oral presentation at the
60th American Society of Hematology (ASH) Annual Meeting and
Exposition in San Diego, CA (Abstract #957).
The data reported from the multicenter, phase 1/2 EVOLVE trial
includes patients who have been treated with JCARH125 in the dose
escalation study. The primary objectives of the phase 1 portion of
the trial are safety and identification of a recommended phase 2
dose. The patients enrolled in the study had to have received at
least three prior lines of multiple myeloma therapy, including an
autologous stem cell transplant for transplant eligible patients, a
proteasome inhibitor, an immunomodulatory drug, and an anti-CD38
monoclonal antibody. Dose escalation is currently ongoing.
“We believe that cellular therapies targeting BCMA will play an
important role in the future treatment of patients with multiple
myeloma,” said Mark Gilbert, M.D., Chief Medical Officer for Juno
Therapeutics, A Celgene Company. “These data from 44 patients in
the EVOLVE trial further support our commitment to innovation in
multiple myeloma clinical research.”
At data cut off, 44 patients have been infused with JCARH125 in
three dose escalation cohorts. These patients were heavily
pretreated, with a median of seven prior lines of therapies (range,
3-23), and 77% had high-risk cytogenetics. Seventy-one percent of
patients experienced grade 1 and 2 cytokine release syndrome (CRS)
with 9% of patients experiencing grade 3/4 CRS. In addition, 18% of
patients experienced grade 1 and 2 neurological events with 7% of
patients experiencing a grade 3/4 event. Other frequent grade 3/4
AEs included neutropenia (86%), anemia (50%), thrombocytopenia
(43%) and infection (14%).
In this first report of JCARH125 data, the median follow up was
only 11 weeks, yet among infused patients, the overall response
rate (ORR) was 82%. At the lowest dose level of 50x106 CAR T cells,
the ORR was 79% and 43% of patients achieved stringent complete
response (sCR) or complete response (CR).
JCARH125 is investigational and has not been approved 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: Twitter, Pinterest, LinkedIn,
Facebook and YouTube.
FORWARD-LOOKING STATEMENTS
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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
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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 our control.
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
Celgene's Annual Report on Form 10-K and other reports filed with
the Securities and Exchange Commission.
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